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Aim To review randomized controlled trials to assess efficacy of a prize-based contingency management procedure in reducing substance use (where a drug-free breath or urine sample provides a chance of winning a prize). Methods A meta-analysis was conducted on papers published from January 2000 to February 2013 to determine the effect size of studies comparing prize-based contingency management to a treatment-as-usual control condition (k = 19 studies). Parallel analyses evaluated the efficacy of both short- (k = nine studies) and long-term outcomes (k = six studies) of prize-based contingency management. Results The average end-of-treatment effect size (Cohen’s d) was 0.46 [95% confidence interval (CI) = 0.37, 0.54]. This effect size decreased at the short-term (≤3-month) post-intervention follow-up to 0.33 (95% CI = 0.12, 0.54) and at the 6-month follow-up time-point there was no detectable effect [d = −0.09 (95% CI = −0.28, 0.10)]. Conclusion Adding prize-based contingency management to behavioral support for substance use disorders can increase short-term abstinence, but the effect does not appear to persist to 6 months. [ABSTRACT FROM AUTHOR]

Background and Aims It has been proposed that more use should be made of Bayes factors in hypothesis testing in addiction research. Bayes factors are the ratios of the likelihood of a specified hypothesis (e.g. an intervention effect within a given range) to another hypothesis (e.g. no effect). They are particularly important for differentiating lack of strong evidence for an effect and evidence for lack of an effect. This paper reviewed randomized trials reported in Addiction between January and June 2013 to assess how far Bayes factors might improve the interpretation of the data. Methods Seventy-five effect sizes and their standard errors were extracted from 12 trials. Seventy-three per cent ( n = 55) of these were non-significant (i.e. P > 0.05). For each non-significant finding a Bayes factor was calculated using a population effect derived from previous research. In sensitivity analyses, a further two Bayes factors were calculated assuming clinically meaningful and plausible ranges around this population effect. Results Twenty per cent ( n = 11) of the non-significant Bayes factors were < ⅓ and 3.6% ( n = 2) were > 3. The other 76.4% ( n = 42) of Bayes factors were between ⅓ and 3. Of these, 26 were in the direction of there being an effect (Bayes factor > 1 and < 3); 12 tended to favour the hypothesis of no effect (Bayes factor < 1 and > ⅓); and for four there was no evidence either way (Bayes factor = 1). In sensitivity analyses, 13.3% of Bayes Factors were < ⅓ ( n = 20), 62.7% ( n = 94) were between ⅓ and 3 and 24.0% ( n = 36) were > 3, showing good concordance with the main results. Conclusions Use of Bayes factors when analysing data from randomized trials of interventions in addiction research can provide important information that would lead to more precise conclusions than are obtained typically using currently prevailing methods. [ABSTRACT FROM AUTHOR]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Background and aims Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers. Design Randomized controlled trial with 3- and 6-month follow-ups. Setting United States. Participants Smokers ( n = 94) from 26 states were enrolled (mean age 36, 56% female). Intervention and comparator Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output ( n = 48; abstinent contingent group, AC), or based on submitting CO samples ( n = 46, submission contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. Measures The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0-100-mm visual analog scale. Findings Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups [odds ratio (OR) = 4.4, 95% confidence interval (CI) = 1.6-12.3], but not at the 3- (29.2% AC and 19.6% SC, OR = 1.7, 95% CI = 0.6-4.4) or 6- (22.9% AC and 13.0% SC, OR = 2.0, 95% CI = 0.7-5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, OR = 3.5, 95% CI = 3.1-4.0; 43.4% AC and 24.6% SC, OR = 2.3, 95% CI = 1.6-3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = −10.3 to 23.8 %, F < 1, P = 0.39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO results, and earning money. Conclusions A contingency management/financial incentive program delivered via the internet improved short-term abstinence rates compared with an internet program without the incentives. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [ABSTRACT FROM AUTHOR]

Aims To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. Design A parallel-group randomized controlled trial of brief motivational ( n = 185), reduction ( n = 186) or usual care ( n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. Setting United States. Participants A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. Measurements The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. Findings A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Conclusions Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. [ABSTRACT FROM AUTHOR]

Aims To compare the use of alternative nicotine products, smoking behavior and tobacco biomarker exposure in smokers unwilling to quit who were assigned randomly to normal nicotine content (NNC) cigarettes or very low nicotine content (VLNC) cigarettes. Design Randomized, parallel-arm 8-week study with assignment to VLNC (VLNC 1, n = 53) or NNC (NNC, n = 27) with access to non-cigarette combusted and non-combusted tobacco/nicotine products or to VLNC with access to only non-combusted products (VLNC2, n = 56). Setting Clinics in Minnesota, USA. Participants Smokers uninterested in quitting smoking with a mean [± standard deviation (SD)] age of 44 (± 14) years and smoking 16 (± seven) cigarettes/day; 51% female, 72% white. Measurements During the experimental period, the measures taken included: rate of alternative products used, amount of and abstinence from combusted tobacco used and tobacco exposure biomarkers. Findings There were higher rates of non-combusted alternative tobacco/nicotine product use in both VLNC conditions versus the NNC condition [rate ratio (RR) = 2.18, 95% confidence interval (CI) = 1.94, 2.46 and RR = 1.64, 95% CI = 1.46, 1.85, respectively] and in VLNC1 versus VLNC2 condition (RR = 1.33, 95% CI = 1.23, 1.44), accompanied by reduced biomarkers of exposure primarily in VLNC2 condition compared to NNC condition ( Ps < 0.05). Fewer combusted products were smoked at almost all visits ( Ps ≤ 0.02) and there were higher rates of abstinence for both VLNC conditions compared with the NNC condition (VLNC1 versus NNC: RR = 9.96, 95% CI = 5.01, 19.81; VLNC2 versus NNC: RR = 11.23, 95% CI = 5.74, 21.97). Conclusion The offer of, and instructions to use, reduced nicotine content cigarettes during an 8-week period led to greater use of alternative tobacco/nicotine products compared with continued use of normal nicotine cigarettes and also reductions in smoking rates. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Aims We tested two aims: (1) the teachable moment (TM): whether second-hand smoke exposure (SHSe) feedback motivates cessation in parents of children with asthma versus parents of healthy children (HC); and (2) whether greater intervention intensity [enhanced-precaution adoption model (PAM)] produces greater cessation than a previously tested intervention (PAM). Design and interventions Aim 1: two home visits (asthma education or child wellness), and cessation induction using motivational interviewing and SHSe feedback. Aim 2: post-home-visits, parents with asthmatic children were randomized to PAM (n = 171; six asthma education calls) or enhanced-PAM (n = 170; six asthma education/smoking cessation calls + repeat SHSe feedback). Setting Rhode Island, USA. Participants Parents of asthmatic (n = 341) or healthy (n = 219) children who did not have to want to quit smoking to enroll. Measurements Measurements were given at baseline, 2, 4, 6 and 12 months. Abstinence was bioverified. Outcomes were 7-day and 30-day point prevalence abstinence (ppa) and SHSe (primary) and asthma morbidity (secondary). Findings Aim 1: the TM was supported: parents of asthmatic children were more than twice as likely to achieve 30-day [odds ratio (OR) = 2.60, 95% confidence interval (CI) = 1.22-5.54] and 7-day ppa (OR = 2.26, 95% CI = 1.13-4.51) at 2 months (primary end-point) and have non-detectable levels of SHSe than HCs. Greater treatment intensity yielded stronger TM effects (OR = 3.60; 95% CI = 1.72-7.55). Aim 2: enhanced-PAM was more likely to achieve 30-day ppa at the primary end-point, 4 months (OR = 2.12, 95% CI 1.09-4.12) and improved asthma outcomes versus PAM. Conclusions Smoking cessation intervention (Motivational Interviewing plus biomarker feedback) appear to motivate smoking cessation more strongly among parents of asthmatic children than among parents of healthy children. Increased intervention intensity yields greater smoking cessation among parents of asthmatic children and better asthma outcomes. [ABSTRACT FROM AUTHOR]

Aims To determine whether the provision of contingencymanagement using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of healthcare resources. Design A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. Settings and participants Data on attendance to vaccination from a UK cluster randomized trial. Intervention Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. Measurement Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. Findings The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programmewas estimated to be £6738 (95% CI = £6297-7172),with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). Conclusions Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%. [ABSTRACT FROM AUTHOR]

Background and Aims While there is broad recognition of the high societal costs of substance use disorders (SUD), treatment rates are low. We examined whether, in the United States, participants with substance or alcohol use disorder would report a greater willingness to enter SUD treatment located in a primary care setting (primary care) or more commonly found specialty care setting in the United States (usual care). Design Randomized survey-embedded experiment. Setting US web-based research panel in which participants were randomized to read one-paragraph vignettes describing treatment in usual care (specialty drug or alcohol treatment center), primary care or collaborative care within a primary care setting. Participants A total of 42 451 panelists aged 18+ were screened for substance or alcohol use disorder using validated diagnostic criteria. Participants included 344 with a substance use disorder and 634 with an alcohol use disorder not in treatment with no prior treatment history. Measures Willingness to enter treatment across vignettes by condition. Findings Among participants with a substance use disorder, 24.6% of those randomized to usual care reported being willing to enter drug treatment compared with 37.2% for primary care [12.6 percentage point difference; 95% confidence interval (CI) = 0.8, 24.4) and 34.0% for collaborative care (9.4 percentage point difference; 95% CI = -2.0, 20.8). Among participants with an alcohol use disorder, 17.6% of those randomized to usual care reported being willing to enter alcohol treatment compared with 20.3% for primary care (2.6 percentage point difference; 95% CI = -4.9, 10.1) and 20.8% for collaborative care (3.1 percentage point difference; 95% CI = -4.3, 10.6). The most common reason for not being willing to enter drug (63%) and alcohol (78%) treatment was the belief that treatment was not needed. Conclusions In the United States, people diagnosed with substance or alcohol use disorders appear to be more willing to enter treatment in a primary care setting than in a specialty drug treatment center. Expanding availability of primary care-based substance use disorder treatment could increase treatment rates in the United States. [ABSTRACT FROM AUTHOR]

Background and Aims Previous studies have reported that people who use a smoking cessation medication while smoking and reduce cigarette consumption spontaneously are three times more likely to stop smoking after a quit date. The aim was to replicate this and assess whether it arises because of willed effortful reduction rather than unwilled reduced drive to smoke caused by medication. Design Secondary analysis of a trial where participants were randomised to smoke as normal or reduce by 75% over 2 weeks prior to quit date, using nicotine replacement therapy (NRT) in both arms. Setting Thirty-one UK primary care practices. Participants A total of 517 adult smokers seeking quitting support in the carbon monoxide (CO) analyses and 421 in the cigarettes/day analyses. Measurements Russell Standard abstinence was recorded 4 weeks after quit date. The randomized groups were combined and the association between reduction and abstinence examined. The second analysis assessed whether this association differed by whether smokers were, or were not, instructed to reduce. Findings In all participants, there was no evidence that reducing cigarettes/day or CO by at least half compared with not reducing predicted abstinence at 4 weeks [risk ratio (RR) = 0.88; 95% confidence interval (CI) = 0.68-1.14 and RR = 1.20; 95% CI = 1.00-1.44, respectively]. However, in smokers instructed to reduce, CO reduction was associated with 4-week abstinence (RR = 1.52; 95% CI = 1.16-2.00), but not among people advised not to reduce (RR = 0.91; 95% CI = 0.67-1.24). Conclusions Smoking reduction prior to a target quit date while on a smoking cessation medication may only predict subsequent abstinence when smokers are consciously attempting to reduce. [ABSTRACT FROM AUTHOR]

Aims In pregnant smoking cessation trial participants, to estimate (1) among women abstinent at the end of pregnancy, the proportion who re-start smoking at time-points afterwards (primary analysis) and (2) among all trial participants, the proportion smoking at the end of pregnancy and at selected time-points during the postpartum period (secondary analysis). Methods Trials identified from two Cochrane reviews plus searches of Medline and EMBASE. Twenty-seven trials were included. The included trials were randomized or quasi-randomized trials of within-pregnancy cessation interventions given to smokers who reported abstinence both at end of pregnancy and at one or more defined time-points after birth. Outcomes were validated biochemically and self-reported continuous abstinence from smoking and 7-day point prevalence abstinence. The primary random-effects meta-analysis used longitudinal data to estimate mean pooled proportions of re-starting smoking; a secondary analysis used cross-sectional data to estimate the mean proportions smoking at different postpartum time-points. Subgroup analyses were performed on biochemically validated abstinence. Results The pooled mean proportion re-starting at 6 months postpartum was 43% [95% confidence interval (CI) = 16-72%, I2 = 96.7%] (11 trials, 571 abstinent women). The pooled mean proportion smoking at the end of pregnancy was 87% (95% CI = 84-90%, I2 = 93.2%) and 94% (95% CI = 92-96%, I2 = 88%) at 6 months postpartum (23 trials, 9262 trial participants). Findings were similar when using biochemically validated abstinence. Conclusions In clinical trials of smoking cessation interventions during pregnancy only 13% are abstinent at term. Of these, 43% re-start by 6 months postpartum. [ABSTRACT FROM AUTHOR]

Aims Syringe exchange has been suggested as a potential conduit to treatment for drug dependence, but this has never been documented in Europe. The primary aim was to compare the effectiveness of strength-based case management intervention (CMI) against referral only to facilitate treatment attendance in a syringe exchange programme. We also assessed the effectiveness of a syringe exchange programme for referral of heroin-dependent patients to evidence-based treatment with methadone or buprenorphine (buprenorphine-naloxone). Design Single-site, two-group randomized controlled trial. Setting The syringe exchange programme in Malmö, Sweden and an out-patient clinic (research treatment facility) for maintenance treatment, situated outside the hospital area and run by Malmö Addiction Centre. Participants Heroin-dependent patients willing to participate ( n = 75) were referred to maintenance treatment and randomized to either a strength-based case management intervention aiming to facilitate referral ( n = 36) or to referral-only ( n = 39). Intervention The intervention group received an appointment for maintenance treatment and a CMI adjusted to individual patient needs. The CMI was semi-structured, assessing the patients' strengths and needs and identifying what practical help they might need to get to the appointment for maintenance treatment. The control group received an appointment for maintenance treatment. Measures The primary outcome was treatment entry. Findings Among patients who turned up for recruitment interview and randomization, the percentage of patients who started treatment was 95% in the intervention group and 94% in the control group. Treatment entry was unrelated to intervention status [unadjusted odds ratio (OR) = 0.92 (0.12-6.89), P = 1.00 and adjusted OR = 0.96 (0.12-7.83)]. Conclusions A randomized controlled trial in a syringe exchange programme showed no evidence that a strength-based case management intervention improved attendance for treatment over referral alone. Attendance rates were high in both groups. [ABSTRACT FROM AUTHOR]

Aims Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment. Design A parallel-arm, pragmatic individually randomized controlled trial. Setting Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics. Intervention Participants in the experimental group (n = 703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n = 704) received a leaflet currently used in practice. Measurements The primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self#x02010;reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables. Findings There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75-1.16; P = 0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. Conclusions In people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse. [ABSTRACT FROM AUTHOR]

Background and Aims A broadly mandated reduction of the nicotine content (RNC) of cigarettes has been proposed in the United States to reduce the addictiveness of cigarettes, to prevent new smokers from becoming addicted and to facilitate quitting in established smokers. The primary aim of this study was to determine whether following 7 months of smoking very low nicotine content cigarettes (VLNC), and then returning to their own cigarettes, smokers would demonstrate persistently reduced nicotine intake compared with baseline or quit smoking. Methods In a community-based clinic 135 smokers not interested in quitting were randomized to one of two groups. A research group smoked their usual brand of cigarettes, followed by five types of research cigarettes with progressively lower nicotine content, each for 1 month, followed by 6 months at the lowest nicotine level (0.5 mg/cigarette) (53 subjects) and then 12 months with no intervention (30 subjects completed). A control group smoked their usual brand for the same period of time (50 subjects at 6 months, 38 completed). Smoking behavior, biomarkers of nicotine intake and smoke toxicant exposure were measured. Results After 7 months smoking VLNC, nicotine intake remained below baseline (plasma cotinine 149 versus 250 ng/ml, P<0.005) with no significant change in cigarettes per day or expired carbon monoxide (CO). During the 12-month follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low [7.5 versus 2% in controls, not significant). Conclusions In smokers not interested in quitting, reducing the nicotine content in cigarettes over 12 months does not appear to result in extinction of nicotine dependence, assessed by persistently reduced nicotine intake or quitting smoking over the subsequent 12 months. [ABSTRACT FROM AUTHOR]

Aims To examine the effectiveness of a personality-targeted intervention program (Adventure trial) delivered by trained teachers to high-risk (HR) high-school students on reducing marijuana use and frequency of use. Design A cluster-randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty-one secondary schools were randomized to intervention ( n = 12) or control ( n = 9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard deviation) age = 13.7 (0.33) years]. Interventions Brief personality-targeted interventions to students with one of four HR profiles: anxiety sensitivity, hopelessness, impulsivity and sensation-seeking. Measurements Primary outcome: marijuana use. Secondary outcome: frequency of use. Assessed using the Reckless Behaviour Questionnaire at intervals of 6 months for 2 years. Personality risk was measured with the Substance Use Risk Profile Scale. Findings Logistic regression analysis revealed significant intervention effects on cannabis use rates at the 6-month follow-up in the intent-to-treat sample [odds ratio (OR) = 0.67, P = 0.05, 95% confidence interval (CI) = 0.45-1.0] and significant reductions in frequency of use at 12- and 18-month follow-up (β = -0.14, P ≤ 0.05, 95% CI = -0.6 to -0.01; β = -0.12, P ≤ 0.05, 95% CI = -0.54 to 0.0), but this was not supported in two-part latent growth models. Subgroup analyses (both logistic and two-part models) reveal that the sensation-seeking intervention delayed the onset of cannabis use among sensation seekers (OR = 0.25, β = -0.833, standard error = 0.342, P = 0.015). Conclusions Personality-targeted interventions can be delivered effectively by trained school staff to delay marijuana use onset among a subset of high-risk teenagers: sensation-seekers. [ABSTRACT FROM AUTHOR]

Aims The extent of variation attributable to regional differences for the efficacy of brief intervention (BI) to reduce hazardous and harmful alcohol consumption is unclear. The primary aim of this study was to determine overall efficacy of BI at 6- and 12-month follow-up in primary health care (PHC) and emergency department (ED) studies. The secondary aim was to examine whether variance in study outcome can be explained by the geographical region in which trials have taken place (European versus non-European). Methods A systematic review and meta-analysis of randomized controlled trials (RCTs) published before August 2014 was undertaken. Twenty RCTs conducted in PHC settings with a total of 8226 participants (European = 4564/non-European = 3662) and eight RCTs conducted in ED settings with a total of 4799 participants (European = 2465/non-European = 2334) were eligible. Primary outcome measure was reduction in grams of alcohol consumed per week for BI and control groups at 6- and 12-month follow-up. An inverse variance model was applied to measure the effect of treatment in mean differences for BI and control groups at 6- and 12-month follow-up. Variance between study outcomes was explored using subgroup analysis of European versus non-European countries. Results For PHC trials at 6-month follow-up, statistically significant benefits of BI were indicated [mean difference (MD) = −21.98 g/week; 95% confidence interval (CI) = −37.40 to −6.57; P = 0.005]. At 12-month follow-up, statistically significant benefit of BI was evident (MD = −30.86 g/week; 95% CI = −46.49 to −15.23; P = 0.0001). For ED trials at 6-month follow-up, statistically significant benefits of BI were indicated (MD = −17.97 g/week; 95% CI = −29.69 to −6.24; P = 0.003). At 12-month follow-up, statistically significant benefit in favour of BI was evident (MD = −18.21 g/week; 95% CI = −26.71 to −9.70; P < 0.0001). No statistically significant differences were detected in subgroup analyses of outcomes for European versus non-European studies. Conclusions Brief intervention (BI) to reduce alcohol consumption is associated with reducing grams of alcohol consumed per week among hazardous and harmful drinkers at 6- and 12-month follow-up in primary health care and emergency department trials. The geographical region in which trials are undertaken does not appear to explain the variance in trial outcomes for reducing alcohol consumption. [ABSTRACT FROM AUTHOR]

Aim The effectiveness of Preventure was tested on drinking behaviour of young adolescents in secondary education in the Netherlands. Design A cluster randomized controlled trial was carried out, with participants assigned randomly to a two-session coping skills intervention or a control no-intervention condition. Setting Fifteen secondary schools throughout the Netherlands; seven schools in the intervention and eight schools in the control condition. Participants A total of 699 adolescents aged 13-15 years participated, 343 allocated to the intervention and 356 to the control condition, with drinking experience and elevated scores in either negative thinking, anxiety sensitivity, impulsivity or sensation-seeking. Intervention and comparator Preventure is a selective school-based alcohol prevention programme targeting personality risk factors. The comparator was a no-intervention control. Measurements The effects of the intervention on the primary outcome past-month binge drinking, and the secondary outcomes binge drinking frequency, alcohol use, alcohol frequency and problem drinking, were examined. The primary analyses of interest were intervention main effects at 12 months post-intervention. In addition, intervention effects on the linear development of binge drinking using a latent-growth curve approach were examined. Findings Binge drinking rates were not significantly different between the intervention (42.9%) and control group (49.2%) at 12 months follow-up [odds ratio (OR) = 1.05, confidence interval (CI) = 0.99, 1.11]. Intention-to-treat analyses revealed no significant intervention effects on alcohol use (53.9 versus 61.5%; OR = 0.99, CI = 0.86, 1.14) and problem drinking (37.0 versus 44.7%; OR = 1.03, CI = 0.92, 1.10) at 12 months follow-up. The post-hoc latent-growth analyses revealed significant effects on the development of binge drinking ( β = -0.16, P = 0.05), and binge drinking frequency ( β = -0.14, P = 0.05). Conclusion The alcohol prevention programme, Preventure, appears to have little or no effect on overall prevalence of binge drinking in adolescents in the Netherlands but may reduce the development of binge drinking over time. [ABSTRACT FROM AUTHOR]

Aims To determine the efficacy of acamprosate and naltrexone in the treatment of those who are alcohol-dependent in reducing lapse/relapse to alcohol consumption and treatment discontinuation, and to examine whether a proportion of the variance in study outcome can be explained by the country in which the trials have taken place. Method A systematic review and meta-analysis of randomized controlled trials published before September 2013 was conducted. The primary outcome measures were the efficacy of acamprosate or naltrexone in reducing lapse/relapse compared to placebo in the treatment of alcohol dependence and treatment discontinuation. Twenty-two randomized controlled trials (RCTs) of the efficacy of acamprosate met inclusion criteria for the meta-analysis, with a total of 2649 participants in the acamprosate group and 2587 in the placebo group. Twenty-seven RCTs of the efficacy of naltrexone met inclusion criteria for the meta-analysis, with a total of 2253 participants in the naltrexone group and 1946 in the placebo group. A random-effects model using a Mantel-Haenszel method was applied to conduct the meta-analysis. Variance in study outcomes was explored using subgroup analysis of Europe versus the rest of the world (ROW). Results The risk of returning to any drinking at 6 months was significantly lower for acamprosate [risk ratio (RR) = 0.83, 95% confidence interval (CI) = 0.78-0.89]. There was little difference in the risk of participants discontinuing treatment for any reason (RR = 0.91, 95% CI = 0.83-1.00) or due to adverse events (RR = 1.30, 95% CI = 0.96-1.75) for the acamprosate compared to placebo groups. The risk of individuals returning to any drinking at approximately 3 months was reduced significantly for the naltrexone group (RR = 0.92, 95% CI = 0.86-1.00), as was the risk of individuals relapsing to heavy drinking at 3 months (RR = 0.85, 95% CI = 0.78-0.93). There was no significant difference between naltrexone and placebo for the risk of individuals discontinuing treatment for any reason (RR = 0.94, 95% CI = 0.84-1.05). There was a significantly greater risk of participants in the naltrexone group discontinuing treatment due to adverse events compared to placebo (RR = 1.72, 95% CI = 1.10-2.70). Subgroup analysis by country (Europe versus ROW) revealed no difference in risk between acamprosate and placebo for the outcomes returning to any drinking at 6 months and discontinuing treatment due to adverse events. For the outcome discontinuation of treatment for any reason, there was a significant difference in RR between Europe and the ROW (χ2 = 11.65, P <0.001) for acamprosate. Acamprosate was associated with a reduction in risk of discontinuing treatment for Europe (RR = 0.86, 95% CI = 0.79-0.95), but an increase in risk of discontinuing treatment for ROW (RR = 1.23, 95% CI = 1.03-1.48). Conclusions Both acamprosate and naltrexone appear to reduce the risk of individuals returning to drinking alcohol in those who are alcohol-dependent. The country in which a randomized control trial (RCT) for the efficacy of acamprosate and naltrexone is completed does not appear to explain the variance in trial outcomes for returning to drinking alcohol or discontinuing drinking due to adverse effects. However, the country in which the RCT of acamprosate are completed may be important for explaining the variance between studies for the outcome 'discontinuing treatment for any reason'. [ABSTRACT FROM AUTHOR]

Aims Within a parent study examining ovarian hormone effects on smoking cessation in women, we conducted an exploratory short-term trial of varenicline versus transdermal nicotine patch. Design Double-blind double-dummy randomized trial. Setting Single-site out-patient research clinic in the United States. Participants Female smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months ( n = 140). Interventions Participants were randomized to receive a 4-week course of (a) varenicline tablets and placebo patches ( n = 67) or (b) placebo tablets and nicotine patches ( n = 73). Two brief cessation counseling sessions were provided for all participants. Measurements The outcome of primary clinical interest was 2-week end-of-treatment abstinence. Secondary outcomes included 1- and 4-week end-of treatment abstinence and abstinence at a post-treatment follow-up visit occurring 4 weeks after treatment conclusion. Breath carbon monoxide (≤ 10 parts per million) was used to confirm biochemically self-reported abstinence. Findings Two-week end-of-treatment abstinence was achieved by 37.3% (25 of 67) of varenicline participants and by 17.8% (13 of 73) of nicotine patch participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 1.3-6.0, P = 0.011]. One-week (44.8 versus 20.6%, OR = 3.1, 95% CI = 1.5-6.6, P = 0.003) and 4-week (22.4 versus 9.6%, OR = 2.7, 95% CI = 1.0-7.2, P = 0.043) end-of-treatment abstinence similarly favored varenicline, although post-treatment follow-up Russell Standard abstinence was not significantly different between groups (23.9 versus 13.7%, OR = 2.0, 95% CI = 0.8-4.7, P = 0.126). Conclusion In an exploratory 4-week head-to-head trial in female smokers, varenicline, compared with nicotine patch, more than doubled the odds of end-of-treatment abstinence, although this diminished somewhat at post-treatment follow-up. [ABSTRACT FROM AUTHOR]

Aims The Randomized Injectable Opioid Treatment Trial ( RIOTT) compared supervised injectable heroin ( SIH) and supervised injectable methadone ( SIM) with optimized oral methadone ( OOM) ( ISRCTN0133807). Heroin addicts (previously unresponsive to treatment) made significant reductions in street heroin use at 6 months when treated with SIH. We now examine secondary outcomes. Design Multi-site randomized controlled trial ( RCT) comparing SIH versus OOM and SIM versus OOM. Setting Three supervised injectable opiate clinics in England. Participants Chronic refractory heroin addicts continuing to inject street heroin virtually daily despite oral substitution treatment ( n = 127), randomized to either SIH( n = 43), SIM( n = 42) or OOM( n = 42). All received high levels of medical and psychosocial support. Measurements Secondary outcomes: wider drug use, crime, health and social functioning at 6 months. Findings At 6 months, no significant differences were found between treatment groups in wider drug use (crack/cocaine, benzodiazepines, alcohol), physical and mental health ( SF-36) or social functioning. Within each treatment group, significant reductions were observed in crime [ SIH = odds ratio ( OR) 0.05; P < 0.001; SIM = OR 0.11; P = 0.002; OOM = OR 0.11; P = 0.003] and money spent per week on illicit drugs ( SIH = mean change £-289.43; P < 0.001; SIM = mean change £-183.41; P < 0.001; OOM = mean change £-162.80; P < 0.001), with SIH significantly more likely to have reduced money spent on illicit drugs versus OOM (mean difference £-92.04; P < 0.001). Significant improvements were seen in physical health for SIH and SIM ( SIH = mean change 3.97; P = 0.008; SIM = mean change 4.73; P = 0.002) and mental health for OOM (mean change 6.04; P = 0.013). Conclusions Supervised injectable heroin treatment and supervised injectable methadone treatment showed no clearly identified benefit over optimized oral methadone in terms of wider drug use, crime, physical and mental health within a 6-month period, despite reducing street heroin use to a greater extent. However, all interventions were associated with improvements in these outcomes. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Aims To examine the efficacy of a brief intervention delivered by a therapist ( TBI) or a computer ( CBI) in preventing cannabis use among adolescents in urban primary care clinics. Design A randomized controlled trial comparing: CBI and TBI versus control. Setting Urban primary care clinics in the United States. Participants Research staff recruited 714 adolescents (aged 12-18 years) who reported no life-time cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI) and 3-, 6- and 12-month assessments. Measurements Using an intent-to-treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use and frequency of delinquency (among 85% completing follow-ups). Findings Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.16%, 16.82%, respectively, P < 0.05), frequency of cannabis use at 3 and 6 months ( P < 0.05) and other drug use at 3 months ( P < 0.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months ( P < 0.05), alcohol use at 6 months ( P < 0.01) and delinquency at 3 months ( P < 0.01). Conclusions Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. [ABSTRACT FROM AUTHOR]

Aims To test the effectiveness of tailored quitline (telephone) counselling among smoking parents recruited into cessation support through their children's primary schools. Design Two-arm randomized controlled trial with 3- and 12-month follow-up. Setting Proactive telephone counselling was administered by the Dutch national quitline. Participants Smoking parents were recruited through their children's primary schools and received either intensive quitline support in combination with tailored supplementary materials ( n = 256) or a standard self-help brochure ( n = 256). Measurements The primary outcome was 7-day point-prevalence abstinence at 12-month follow-up. Also measured were baseline characteristics, use of and adherence to nicotine replacement therapy and pharmacotherapy, smoking characteristics and implementation of a home smoking ban. Findings Parents who received quitline counselling were more likely to report 7-day point-prevalence abstinence at 12-month assessment [34.0 versus 18.0%, odds ratio ( OR) = 2.35, confidence interval ( CI) = 1.56-3.54] than those who received a standard self-help brochure. Parents who received quitline counselling were more likely to use nicotine replacement therapy ( P < 0.001) than those who received a standard self-help brochure. Among parents who did not achieve abstinence, those who received quitline counselling smoked fewer cigarettes at 3-month ( P < 0.001) and 12-month assessment ( P < 0.001), were more likely to make a quit attempt ( P < 0.001), to achieve 24 hours' abstinence ( P < 0.001) and to implement a complete home smoking ban ( P < 0.01). Conclusions Intensive quitline support tailored to smoking parents is an effective method for helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking. [ABSTRACT FROM AUTHOR]

Background and Aims In 2005 the American College of Surgeons passed a mandate requiring that level I trauma centers have mechanisms to identify and intervene with problem drinkers. The aim of this investigation was to determine if a multi-level trauma center intervention targeting both providers and patients would lead to higher-quality alcohol screening and brief intervention ( SBI) when compared with trauma center mandate compliance without implementation enhancements. Design Cluster randomized trial in which intervention site (site n = 10, patient n = 409) providers received 1-day workshop training on evidence-based motivational interviewing ( MI) alcohol interventions and four 30-minute feedback and coaching sessions; control sites (site n = 10, patient n = 469) implemented the mandate without study team training enhancements. Setting Trauma centers in the United States of America. Participants A total of 878 blood alcohol-positive in-patients with and without traumatic brain injury ( TBI). Measurements MI skills of providers were assessed with fidelity coded standardized patient interviews. All patients were interviewed at baseline and 6- and 12-months post-injury with the Alcohol Use Disorders Identification Test ( AUDIT). Findings Intervention site providers consistently demonstrated enhanced MI skills compared with control providers. Intervention patients demonstrated an 8% reduction in AUDIT hazardous drinking relative to controls over the course of the year after injury (relative risk = 0.88, 95%, confidence interval = 0.79, 0.98). Intervention patients were more likely to demonstrate improvements in alcohol use problems in the absence of traumatic brain injury (TBI) ( P = 0.002). Conclusion Trauma center providers can be trained to deliver higher-quality alcohol screening and brief intervention (SBI) than untrained providers, which is associated with modest reductions in alcohol use problems, particularly among patients without TBI. [ABSTRACT FROM AUTHOR]

Aims To evaluate a heroin overdose management training programme for family members based on emergency recovery procedures and take-home naloxone ( THN) administration. Design A two-group, parallel-arm, non-blinded, randomized controlled trial of group-based training versus an information-only control. Setting Training events delivered in community addiction treatment services in three locations in England. Participants A total of 187 family members and carers allocated to receive either THN training or basic information on opioid overdose management ( n = 95 and n = 92, respectively), with 123 participants completing the study. Measurements The primary outcome measure was a self-completion Opioid Overdose Knowledge Scale ( OOKS; range 0-45) and an Opioid Overdose Attitudes Scale ( OOAS; range 28-140) was the secondary outcome measure. Each group was assessed before receiving their assigned condition and followed-up 3 months after. Events of witnessing and managing an overdose during follow-up were also recorded. Findings At follow-up, study participants who had received THN training reported greater overdose-related knowledge relative to those receiving basic information only [ OOKS mean difference, 4.08 (95% confidence interval, 2.10-6.06; P < 0.001); Cohen's d = 0.74 (0.37-1.10)]. There were also more positive opioid overdose-related attitudes among the trained group at follow-up [ OOAS mean difference, 7.47 (3.13-11.82); P = 0.001; d = 0.61 (0.25-0.97)]. At the individual level 35 and 54%, respectively, of the experimental group increased their knowledge and attitudes compared with 11 and 30% of the control group. During follow-up, 13 participants witnessed an overdose with naloxone administered on eight occasions: five among the THN-trained group and three among the controls. Conclusions Take-home naloxone training for family members of heroin users increases opioid overdose-related knowledge and competence and these benefits are well retained after 3 months. [ABSTRACT FROM AUTHOR]

Aims To compare a brief versus a brief plus intensive self-help version of 'Balance', a fully automated online alcohol intervention, on self-reported alcohol consumption. Design A pragmatic randomized controlled trial. Participants in both conditions received an online single session screening procedure including personalized normative feedback. The control group also received an online booklet about the effects of alcohol. The treatment group received the online multi-session follow-up program, Balance. Setting Online study in Norway. Participants At-risk drinkers were recruited by internet advertisements and assigned randomly to one of the two conditions ( n = 244). Measurements The primary outcome was self-reported alcohol consumption the previous week measured 6 months after screening. Findings Regression analysis, using baseline carried forward imputation (intent-to-treat), with baseline variables as covariates, showed that intervention significantly affected alcohol consumption at 6 months (B = 2.96; 95% confidence interval = 0.02-5.90; P = 0.049). Participants in the intensive self-help group drank an average of three fewer standard alcohol units compared with participants in the brief self-help group. Conclusions The online Balance intervention, added to a brief online screening intervention, may aid reduction in alcohol consumption compared with the screening intervention and an educational booklet. [ABSTRACT FROM AUTHOR]

Aims This study performs the first cost-effectiveness analysis ( CEA) of Recovery Management Checkups ( RMC) for adults with chronic substance use disorders. Design Cost-effectiveness analysis of a randomized clinical trial of RMC. Participants were assigned randomly to a control condition of outcome monitoring ( OM-only) or the experimental condition OM-plus- RMC, with quarterly follow-up for 4 years. Setting Participants were recruited from the largest central intake unit for substance abuse treatment in Chicago, Illinois, USA. Participants A total of 446 participants who were 38 years old on average, 54% male, and predominantly African American (85%). Measurements Data on the quarterly cost per participant come from a previous study of OM and RMC intervention costs. Effectiveness is measured as the number of days of abstinence and number of substance use-related problems. Findings Over the 4-year trial, OM-plus- RMC cost on average $2184 more than OM-only ( P < 0.01). Participants in OM-plus- RMC averaged 1026 days abstinent and had 89 substance use-related problems. OM-only averaged 932 days abstinent and reported 126 substance use-related problems. Mean differences for both effectiveness measures were statistically significant ( P < 0.01). The incremental cost-effectiveness ratio for OM-plus- RMC was $23.38 per day abstinent and $59.51 per reduced substance-related problem. When additional costs to society were factored into the analysis, OM-plus- RMC was less costly and more effective than OM-only. Conclusions Recovery Management Checkups are a cost-effective and potentially cost-saving strategy for promoting abstinence and reducing substance use-related problems among chronic substance users. [ABSTRACT FROM AUTHOR]

Aims To assess the efficacy of methylphenidate as a substitution therapy for amphetamine/methamphetamine dependence in Finland and New Zealand. Design Parallel-group, double-blind, randomized placebo-controlled trial. Setting Out-patient care. Participants Amphetamine-/methamphetamine-dependent, aged 16-65 years. Measurements The primary outcome measure was presence/absence of amphetamine/methamphetamine in urine samples collected twice weekly. Secondary measures included treatment adherence, alterations in craving scores and self-reported use. Primary analysis was by intention-to-treat ( ITT). The study drug, methylphenidate (as Concerta®), was up-titrated over 2 weeks to a maximum dose of 54 mg daily and continued for a further 20 weeks. Doses were given under daily supervision at the clinics. Findings Seventy-nine participants were randomized (40 methylphenidate; 39 placebo); 76 received allocated treatment and 27 completed the trial. ITT analysis ( n = 78) showed no statistically significant difference in the percentage of positive urines between the methylphenidate and placebo arms (odds ratio: 0.95, 95% confidence interval: 0.83-1.08). However, there was a significant difference ( P < 0.05) between the active and placebo arms in retention, the placebo arm displaying a significantly lower retention from 6 weeks that persisted until the end of the trial. Conclusions The trial failed to replicate earlier findings suggesting that methylphenidate was superior to placebo. The low retention rate confounded the ability to draw firm conclusions about efficacy. The higher retention rate was observed in the methylphenidate arm. Any replication of this work would need to consider alternatives to the rigid clinic attendance criteria, and consider an increased dose. [ABSTRACT FROM AUTHOR]

Aims To assess the effects of adding motivational interviewing ( MI) counseling to nicotine patch for smoking cessation among homeless smokers. Design Two-group randomized controlled trial with 26-week follow-up. Participants and setting A total of 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/ St Paul, Minnesota, USA. Intervention and measurements All participants received 8-week treatment of 21-mg nicotine patch. In addition, participants in the intervention group received six individual sessions of MI counseling which aimed to increase adherence to nicotine patches and to motivate cessation. Participants in the standard care control group received one session of brief advice to quit smoking. Primary outcome was 7-day abstinence from cigarette smoking at 26 weeks, as validated by exhaled carbon monoxide and salivary cotinine. Findings Using intention-to-treat analysis, verified 7-day abstinence rate at week 26 for the intervention group was non-significantly higher than for the control group (9.3% versus 5.6%, P = 0.15). Among participants who did not quit smoking, reduction in number of cigarettes from baseline to week 26 was equally high in both study groups (−13.7 ± 11.9 for MI versus −13.5 ± 16.2 for standard care). Conclusions Adding motivational interviewing counseling to nicotine patch did not increase smoking rate significantly at 26-week follow-up for homeless smokers. [ABSTRACT FROM AUTHOR]

Aim To test the effectiveness of motivational interviewing ( MI) to reduce the risk of an alcohol exposed pregnancy ( AEP) in a high-risk population. Design Randomized controlled trial. Setting Rural population in the Western Cape, South Africa. Participants A total of 165 women aged 18-44 years at risk of AEP. Intervention Five-session MI intervention. Measurements Structured questionnaires were administered pre-intervention and at 3 and 12 months follow-up. The primary outcome measure was AEP at 12 months. Secondary outcomes were AEP at 3 months, and alcohol use and effective contraception at 3 and 12 months. Findings There was a significant difference in the decline in the proportion of women at risk for an AEP in the MI group at 3 months (50 versus 24.59%; P = 0.004), maintained at 12 months (50.82 versus 28.12%; P = 0.009). In an intention-to-treat analysis these differences were also significant (32.93 versus 18.07%; P = 0.029; and 37.80 versus 21.69%; P = 0.024, respectively). The odds ratio for no longer being at risk of an AEP ( MI versus control) at 12 months was 2.64 [95% confidence interval ( CI): 1.18-5.94]. In the intention-to-treat analysis this ratio was 2.19 (95% CI: 1.05-4.65). Conclusions A five-session motivational interviewing intervention was found to be effective with women at risk of an alcohol-exposed pregnancy, and could be implemented as part of routine primary care clinic services in similar populations. The message of 'no alcohol in pregnancy' should be adapted to include better family planning and early recognition of pregnancy. [ABSTRACT FROM AUTHOR]

Aims To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Design Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling. Setting The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Participants Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues. Measurements The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems ( MEMS)], sexual risk behavior and abstinence from methamphetamine. Findings Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio ( RR) 0.88, 95% confidence interval ( CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms ( MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness ( P < 0.05). Conclusion Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults. [ABSTRACT FROM AUTHOR]

Aims To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Design Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) on Q, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and on Q; and (v) a choice of either alone or the combined program. Setting Australia, via a mix of internet and telephone contacts. Participants A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources ( n = 1335) or cold-contacted from internet panels ( n = 2195). Measurements The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Findings Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio ( OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence ( OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Conclusions Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. [ABSTRACT FROM AUTHOR]

Aims To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Design Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Setting Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants Participants ( n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Measurements Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. Findings The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. Conclusions A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. [ABSTRACT FROM AUTHOR]

Aims To characterize infections and compare obstetric outcomes in opioid-dependent pregnant women who participated in a randomized clinical trial comparing agonist medications, methadone and buprenorphine. Design Incidence of infections was identified as part of the screening medical assessment. As part of a planned secondary analysis, analysis of variance and polytomous logistic regressions were conducted on obstetric outcome variables using treatment randomization condition (maternal maintenance with either methadone or buprenorphine) as the predictor variable, controlling for differences between study sites. Setting Six United States sites and one European site that provided comprehensive treatment to opioid-dependent pregnant women. Participants Pregnant opioid-dependent women ( n = 131) who delivered while participating in the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study. Measurements Obstetric, infectious and other maternal medical complications captured by medical records, physical examination, blood tests and self-report. Neonatal medical complications captured by medical records. Findings Hepatitis C was the most common infection (32.3%), followed by hepatitis B (7.6%) and chlamydia (6.1%) among participants at study enrollment. Maternal methadone versus buprenorphine maintenance was associated with a higher incidence of preterm labor ( P = 0.04) and a significantly higher percentage of signs of respiratory distress in neonates at delivery ( P = 0.05). Other medical and obstetric complications were infrequent in the total sample, as well as in both methadone and buprenorphine conditions. Conclusions Buprenorphine appears to have an acceptable safety profile for use during pregnancy. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real-world conditions has tested this hypothesis. Design and setting Clinical trial conducted across eight US study sites. Participants and measurements Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3-5 of treatment in a randomized, double-blind placebo-controlled trial of 21-mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7-day point-prevalence) at weeks 6 and 10. Findings Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks [8.3% versus 0.8%; relative risk (RR) = 11.0, P < 0.001] and at 10 weeks (9.6% versus 2.6%; RR = 3.7, P < 0.001). Conclusions Continuing treatment to aid smoking cessation with active patches promotes recovery from lapses. Smokers should be encouraged to persist with patch treatment if they lapse to smoking. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To determine whether collaborative behavioral management (CBM) reduces substance use, crime and re-arrest among drug-involved parolees. Design Step'n Out was a randomized behavioral trial of CBM versus standard parole (SP) during 2004-08. CBM adapted evidence-based role induction, behavioral contracting and contingent reinforcement to provide parole officer/treatment counselor dyads with positive tools in addition to sanctions to manage parolees' behavior over 12 weeks. Setting Six parole offices in five states in the USA. Participants Parolee volunteers with a mandate for addiction treatment and a minimum of 3 months of parole ( n = 476). Follow-up was 94% at 3 months and 86% at 9 months. Measurements Drug use and crime in a given month from calendar interviews 3 and 9 months after parole initiation, and re-arrests from criminal justice administrative data. Findings The CBM group had fewer months in which they used their primary drug [adjusted risk ratio (ARR) 0.20, 95% confidence interval (CI): 0.05, 0.78, P = 0.02] and alcohol (ARR 0.38, 95% CI: 0.22, 0.66, P = 0.006) over follow-up. CBM had its greatest effects among parolees who reported marijuana or another 'non-hard' drug as their primary drug; parolees who preferred stimulants or opiates did not benefit. No differences were seen in total crime, re-arrests or parole revocations. Conclusions Collaborative behavioral management may reduce substance use among primary marijuana or other 'non-hard' drug-using parolees without increasing revocations. Because the majority of drug violation arrests in the United States are for marijuana, these findings have important implications for the management of a substantial proportion of the US community correctional population. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To review and analyse in experimentally controlled studies the impact of alcohol consumption on intentions to engage in unprotected sex. To draw conclusions with respect to the question of whether alcohol has an independent effect on the incidence of human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Methods A systematic review and meta-analysis of randomized controlled studies examined the association between blood alcohol content (BAC) and self-perceived likelihood of using a condom during intercourse. The systematic review and meta-analysis were conducted according to internationally standardized protocols (Preferred Reporting Items for Systematic Reviews and Meta-Analyses: PRISMA). The meta-analysis included an estimate of the dose-response effect, tests for publication bias and sensitivity analyses. Results Of the 12 studies included in the quantitative synthesis, our pooled analysis indicated that an increase in BAC of 0.1 mg/ml resulted in an increase of 5.0% (95% CI: 2.8-7.1%) in the indicated likelihood (indicated by a Likert scale) of engaging in unprotected sex. After adjusting for potential publication bias, this estimate dropped to 2.9% (95% CI: 2.0-3.9%). Thus, the larger the alcohol intake and the subsequent level of BAC, the higher the intentions to engage in unsafe sex. The main results were homogeneous, persisted in sensitivity analyses and after correction for publication bias. Conclusions Alcohol use is an independent risk factor for intentions to engage in unprotected sex, and as risky sex intentions have been shown to be linked to actual risk behavior, the role of alcohol consumption in the transmission of HIV and other STIs may be of public health importance. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study aimed to assess the effectiveness of the Örebro prevention programme (ÖPP), an alcohol misuse prevention programme that aims to reduce youth drinking by changing parental behaviour. Design Cluster-randomized trial, with schools assigned randomly to the ÖPP or no intervention. Setting Forty municipal schools in 13 counties in Sweden. Participants A total of 1752 students in the 7th grade and 1314 parents were assessed at baseline. Students' follow-up rates in the 8th and 9th grades were 92.1% and 88.4%, respectively. Measurements Classroom questionnaires to students and postal questionnaires to parents were administered before randomization and 12 and 30 months post-baseline. Findings Two-level logistic regression models, under four different methods of addressing the problem of loss to follow-up, revealed a statistically significant programme effect for only one of three drinking outcomes under one loss-to-follow-up method, and that effect was observed only at the 12-month follow-up. Conclusions The Örebro prevention programme as currently delivered in Sweden does not appear to reduce or delay youth drunkenness. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Dual epidemics of human immunodeficiency virus (HIV) and alcohol use disorders, and a dearth of professional resources for behavioral treatment in sub-Saharan Africa, suggest the need for development of culturally relevant and feasible interventions. The purpose of this study was to test the preliminary efficacy of a culturally adapted six-session gender-stratified group cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use among HIV-infected out-patients in Eldoret, Kenya. Design Randomized clinical trial comparing CBT against a usual care assessment-only control. Setting A large HIV out-patient clinic in Eldoret, Kenya, part of the Academic Model for Providing Access to Healthcare collaboration. Participants Seventy-five HIV-infected out-patients who were antiretroviral (ARV)-initiated or ARV-eligible and who reported hazardous or binge drinking. Measurements Percentage of drinking days (PDD) and mean drinks per drinking days (DDD) measured continuously using the Time line Follow back method. Findings There were 299 ineligible and 102 eligible out-patients with 12 refusals. Effect sizes of the change in alcohol use since baseline between the two conditions at the 30-day follow-up were large [ d = 0.95, P = 0.0002, mean difference = 24.93, 95% confidence interval (CI): 12.43, 37.43 PDD; d = 0.76, P = 0.002, mean difference = 2.88, 95% CI: 1.05, 4.70 DDD]. Randomized participants attended 93% of the six CBT sessions offered. Reported alcohol abstinence at the 90-day follow-up was 69% (CBT) and 38% (usual care). Paraprofessional counselors achieved independent ratings of adherence and competence equivalent to college-educated therapists in the United States. Treatment effect sizes were comparable to alcohol intervention studies conducted in the United States. Conclusions Cognitive-behavioral therapy can be adapted successfully to group paraprofessional delivery in Kenya and may be effective in reducing alcohol use among HIV-infected Kenyan out-patients. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smoking cessation trials generally record information on daily smoking behavior, but base analyses on measures of smoking status at the end of treatment (EOT). We present an alternative approach that analyzes the entire sequence of daily smoking status observations. Methods We analyzed daily abstinence data from a smoking cessation trial, using two longitudinal logistic regression methods: a mixed-effects (ME) model and a generalized estimating equations (GEE) model. We compared results to a standard analysis that takes abstinence status at EOT as outcome. We evaluated time-varying covariates (smoking history and time-varying drug effect) in the longitudinal analysis and compared ME and GEE approaches. Results We observed some differences in the estimated treatment effect odds ratios across models, with narrower confidence intervals under the longitudinal models. GEE yields similar results to ME when only baseline factors appear in the model, but gives biased results when one includes time-varying covariates. The longitudinal models indicate that the quit probability declines and the drug effect varies over time. Both the previous day's smoking status and recent smoking history predict quit probability, independently of the drug effect. Conclusion When analysing outcomes of studies from smoking cessation interventions, longitudinal models with multiple outcome data points, rather than just end of treatment, can makes efficient use of the data and incorporate time-varying covariates. The generalized estimating equations approach should be avoided when using time-varying predictors. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To examine person-specific urge-to-smoke trajectories during the first 7 days of abstinence and the relationship of trajectory parameters to continuous abstinence, demographics, medication and smoking history. Design Hierarchical linear modeling was used to model person-specific trajectories for urge-to-smoke. Setting Two university-based smoking cessation trials. Participants Treatment-seeking smokers in a clinical trial of transdermal nicotine ( n = 275) versus nicotine spray ( n = 239) and of bupropion ( n = 223) versus placebo ( n = 198). Measurements Self-reported urge-to-smoke for 7 days after the planned quit date, and 7-day point prevalence and continuous abstinence at end of treatment (EOT) and 6 months. Findings Urge-to-smoke trajectory parameters (average level, slope, curvature and volatility) varied substantially among individuals, had modest intercorrelations and predicted continuous and point prevalence abstinence at EOT and at 6 months. Higher trajectory level, slope and volatility were all significantly ( P ≤ 0.001) associated with a reduced likelihood of abstinence at EOT (odds ratios 0.44-0.75) and at 6-month follow-up (odds ratios from 0.63 to 0.78), controlling for demographic, medication and smoking use variables. Conclusion Higher urge-to-smoke trajectory parameters of level, slope and volatility (measured over 7 days) predict continuous and 7-day point prevalence at EOT and 6 months. Although there were some associations of trajectory parameters with demographics and smoking history, the associations of trajectory parameters with relapse were relatively uninfluenced by demographics and smoking history. [ABSTRACT FROM AUTHOR]

To examine the effectiveness of smoking reduction counselling plus free nicotine replacement therapy (NRT) for smokers not willing to quit. A total of 1154 Chinese adult smokers not willing to quit but who were interested in reducing smoking were allocated randomly to three arms. Intervention group A1 ( n = 479) received face-to-face counselling on smoking reduction and adherence to NRT at baseline, 1 week and 4 weeks with 4 weeks of free NRT. Group A2 ( n = 449) received the same intervention, but without the adherence intervention. Control group B ( n = 226) received simple cessation advice at baseline. Self-reported 7-day point prevalence of tobacco abstinence and reduction of cigarette consumption (≥50%) at 6 months and continuous use of NRT for 4 weeks at 3 months. Using intention-to-treat analysis, compared to control group B, the intervention groups (A1 + A2) had achieved higher 6-month tobacco abstinence (17.0% versus 10.2%, P = 0.01) and reduction rates (50.9% versus 25.7%, P < 0.001). There was no significant difference in the 4-week NRT adherence rate at 3 months, but group A1 achieved a higher abstinence rate than group A2 at 6 months (20.9% versus 12.9%; P = 0.001). In smokers with no immediate plans to quit, smoking reduction programmes with behavioural support and nicotine replacement therapy are more effective than brief advice to quit. Current guidelines recommend advice to quit on medical grounds as the best clinical intervention in this group of smokers, but smoking reduction programmes offer an alternative and effective option. [ABSTRACT FROM AUTHOR]

To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Single-blind, randomized controlled trial. New Zealand. A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03], had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. [ABSTRACT FROM AUTHOR]