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Background and Aims: Long‐acting injectable buprenorphine (LAIB) is a new treatment for opioid use disorder that is generating positive outcomes. Negative effects are typically mild and transient, but can occasionally be serious, resulting in treatment discontinuation/non‐adherence. This paper aims to analyse patients' accounts of how they felt during the first 72 h after initiating LAIB. Methods: Semi‐structured interviews were conducted (June 2021–March 2022) with 26 people (18 males and 8 females) who had started LAIB within the previous 72 h. Participants were recruited from treatment services in England and Wales and were interviewed by telephone using a topic guide. Interviews were audio‐recorded, transcribed and coded. The concepts of embodiment and embodied cognition framed the analyses. Data on participants' substance use, initiation onto LAIB and feelings were tabulated. Next, participants' accounts of how they felt were analysed following the stages of Iterative Categorization. Results: Participants reported complex combinations of changing negative and positive feelings. Bodily experiences included withdrawal symptoms, poor sleep, injection‐site pain/soreness, lethargy and heightened senses inducing nausea ('distressed bodies'), but also enhanced somatic wellbeing, improved sleep, better skin, increased appetite, reduced constipation and heightened senses inducing pleasure ('returning body functions'). Cognitive responses included anxiety, uncertainties and low mood/depression ('the mind in crisis') and improved mood, greater positivity and reduced craving ('feeling psychologically better'). Whereas most negative effects reported are widely recognized, the early benefits of treatment described are less well‐documented and may be an overlooked distinctive feature of LAIB. Conclusions: During the first 72 h after initiating long‐acting injectable buprenorphine, new patients report experiencing a range of interconnected positive and negative short‐term effects. Providing new patients with information about the range and nature of these effects can prepare them for what to expect and help them manage feelings and reduce anxiety. In turn, this may increase medication adherence. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aims: Dr Leslie E. Keeley was perhaps the world's most famous addiction cure doctor at the turn of the 20th century, but mainstream medicine dismissed him as a quack because he dispensed a secret cure. This paper aims to describe Keeley's now largely forgotten story and to draw attention to the role of contextual issues in the acceptance or rejection of any theory of addiction, particularly the neuroscientific theories of the early 21st century. Methods: This study is a qualitative assessment and contextualization of historical documents. Its main sources are archival and are, for the most part, unknown to historians. The paper also offers intellectual and historical context that is drawn from leading historical and sociological analyses. Results: Keeley's addiction cure was dismissed as quackery because it failed to meet the changing standards of late 19th‐century professional medicine. This begs us to consider contextual issues in any assertion of the viability of addiction therapeutics, in the present as well the past. Conclusions: Keeley's near erasure from the historical record was a consequence of a broader, late 19th‐century medical power struggle that took precedence over the testimony of tens of thousands of satisfied patients who claimed that Keeley's cure worked. Context matters in the assessment of the viability of theories of addiction from the past, but also from the present. Historians and social scientists are well placed to make those assessments. [ABSTRACT FROM AUTHOR]

Aims Regression to the mean (RTM) refers to the tendency for a group of cases that differ from the population mean to move (regress) towards the mean, on average, when re-assessed, if scores at the two points are less than perfectly correlated. This paper considers factors that affect the magnitude of RTM and how RTM may impact findings from primary studies and reviews of substance use disorder (SUD) treatment. Design and methods The paper is guided largely by A Primer on Regression Artifacts by Campbell and Kenny. It reviews potential RTM effects in three areas of SUD treatment research. One is the extent to which within-group improvement in comparative treatment trials, including ‘placebo effects’, is a function of RTM. The second is the vulnerability of treatment evaluations employing non-equivalent control group designs to RTM and biased estimates of treatment effects when matching, or statistical equating is used to adjust for pre-existing group differences. The final issue is the impact of RTM in syntheses of research findings on SUD treatments. In particular, the tendency for later studies of a particular intervention to have smaller treatment effect sizes relative to earlier studies is considered as an RTM phenomenon. Findings RTM is a pervasive, but often unrecognized phenomenon that can bias findings in SUD treatment studies and in systematic reviews of that research. Conclusion SUD treatment researchers should be aware of RTM, take any available steps to reduce it, and try to diagnose whether it is still affecting research findings. [ABSTRACT FROM AUTHOR]

An important factor that has thus far limited the effectiveness of pharmacotherapies for patients with alcohol and opioid dependence is poor adherence to medication regimens. This paper presents a review of issues related to medication adherence in patients with these substance use disorders.A literature review was conducted of English language publications relating to medication adherence among patients with alcohol or opioid dependence.The paper places the topic in the context of adherence difficulties among patients with a variety of chronic medical and psychiatric illnesses. Difficulties measuring adherence are discussed, and strategies to improve medication adherence are reviewed. These include specific interventions that prescribing clinicians can implement in their individual meetings with patients; the use of external reinforcers, such as positive and negative contingencies, and involvement of family members or significant others; and specific prescribing and dosing practices that may improve adherence.As the use of pharmacotherapy for substance-dependent patients increases, rigorous and innovative approaches to encourage medication adherence should be sought. [ABSTRACT FROM AUTHOR]

Prescribing nicotine replacement therapy (NRT) or bupropion for smoking cessation is of considerable importance to public health but little is known about prescribing practices. This paper examines general practitioners’ (GPs’) prescribing patterns in Britain where these drugs are reimbursed. The results have implications for other health-care systems considering introducing reimbursement.Postal survey conducted in 2002 of a random sample of 1088 GPs in England and Wales, of whom 642 (59%) responded.Number of requests GPs reported having received from patients for NRT and bupropion over the past month, the number of prescriptions they reported issuing and ratings of attitudes to these medications.GPs reported receiving an average of 4.3 requests for NRT and 1.9 for bupropion in the previous month. They reported issuing 3.5 prescriptions for NRT and 1.2 for bupropion. Almost all GPs accepted that NRT (95%) and bupropion (97%) should be reimbursable on National Health Service (NHS) prescription. However, a significant minority of those who received requests for prescriptions did not issue any (8% for NRT and 26% for bupropion). This was related to whether they thought these products should be available on NHS prescription for both NRT and bupropion (OR = 0.66,P < 0.05), which in turn was related to beliefs about whether smokers should have to pay for treatment themselves, the cost-effectiveness of NRT/bupropion and the low priority they would give NRT/bupropion in the drug budget. For bupropion, concern about side-effects independently predicted not prescribing[odds ratio (OR) = 1.46,P < 0.03].In the British health-care system, which has a well-established system for technology assessment and professionally endorsed guidelines, a significant minority of GPs decline all patient requests for stop-smoking medicines. [ABSTRACT FROM AUTHOR]

Aims To study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. Design A multi-site ( n = 10), two-group, parallel, pragmatic randomized controlled trial. Setting A network of primary health-care centres in the Netherlands. Participants A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Intervention and comparator Patients were randomized to receive individual counselling by a practice nurse (PN) ( n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. Measurements The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Findings Abstinence rates in the PN versus GP groups were 32.2% ( n = 48) versus 39.0% [ n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% ( n = 38) versus 28.8% ( n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Conclusions Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. [ABSTRACT FROM AUTHOR]

Aims Varenicline was compared with transdermal nicotine (NRT) for smokers with current substance use disorders (SUD) for effects on 3-month smoking abstinence (primary outcome) and, secondarily, on 3- and 6 month abstinence while adjusting for medication adherence, and on additional smoking and substance use outcomes. Moderation by major depressive disorder history (MDD) and adherence were investigated. Design Double-blind double-placebo-controlled randomized design, stratifying by MDD, gender and nicotine dependence, with 3 and 6 months follow-up. Setting University offices in Rhode Island, USA. Participants Adult smokers ( n = 137), in SUD treatment, substance abstinent <12 months ( n = 77 varenicline, 60 NRT). Intervention and comparator Twelve weeks of varenicline (2 mg/day, after 1-week dose run-up) or NRT (21 mg/day decreasing to 7 mg/day). Measurements Primary: point-prevalence smoking abstinence (7-day, confirmed) at 3 months. Secondary: point-prevalence abstinence at 6 months, quantity and frequency of smoking and substance use at 3 and 6 months, and within-treatment abstinence, medication adherence and depressive symptoms. Smoking outcome analyses were repeated controlling for adherence and investigating adherence as a moderator. Findings Effects on 3-month abstinence were P < 0.065 without a covariate (Bayes factor 3.35, supporting the effect strongly) and differed significantly when controlling for baseline smoking [varenicline: 13%, NRT: 3%; odds ratio (OR) = 4.81, 95% confidence interval (CI) 1.00, 23.13, P < 0.05]. The threefold difference at 6 months was not significant. Medication effect on abstinence across time was significant ( P < 0.05) covarying adherence and baseline smoking (OR = 6.40, 95% CI = 1.00, 40.93). Medication differences in 3-month abstinence occurred among participants with ≥ 77% adherence ( P < 0.02). No significant medication effects on heavy drinking, drug use or depressive symptoms were found. Conclusions Varenicline appears to improve the chances of achieving at least 3 months of smoking abstinence in smokers with substance use disorders trying to stop, compared with transdermal nicotine patches, the effect being independent of history of depressive disorder. [ABSTRACT FROM AUTHOR]

Aims Varenicline is used in smoking cessation. The aims of the trial were to test for differences between standard 1- and 0.5-mg doses (both twice daily during 8 weeks) in (1) abstinence, (2) adherence and (3) side effects. Design Open-label randomized parallel-group controlled trial with 1-year follow-up. All those randomized were included in the final sample using an intention-to-treat (ITT) approach. Setting Stop-Smoking Clinic of the Virgen Macarena University Hospital in Seville, Spain. Participants The study comprised smokers ( n = 484), 59.5% of whom were men with a mean age of 50.67 years and a smoking history of 37.5 pack-years. Intervention and comparator Participants were randomized to 1 mg ( n = 245) versus 0.5 mg ( n = 239) and received behavioural support, which consisted of a baseline visit and six follow-ups during 1 year. Measurements The primary outcome was continuous self-reported abstinence during 1 year, with biochemical verification. The secondary outcomes were adherence and side effects. Also measured were baseline demographics, medical history and smoking characteristics. Findings Abstinence rates at 1 year were 46.5% with 1 mg versus 46.4% with 0.5 mg [odds ratio (OR) = 0.997; 95% confidence interval (CI) = 0.7-1.43; P = 1.0]; Bayes factor in favour of H0 = 238.507, Bayes factor against H0 = 0.004. Treatment adherence was similar in both regimens (OR = 1.16; 95% CI = 0.8-1.7; P = 0.44). Side effects were reported in 19.3% of cases with 1 mg versus 12.1% with 0.5 mg, although with no significant differences between regimens (OR = 1.73; 95% CI = 0.94-3.18; P = 0.093). Conclusions There appears to be no difference in smoking cessation effectiveness between 1 mg and 0.5 mg varenicline, both administered twice daily for 8 weeks, with similar rates of abstinence (46.5% versus 46.4%), adherence and side effects. [ABSTRACT FROM AUTHOR]

Aims To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [ P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 ( P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. [ABSTRACT FROM AUTHOR]

The article presents drug and pharmaceutical industry news briefs as of August 2016. Great Britain has introduced uniform packaging regulations for tobacco products. The U.S. Food and Drug Administration (FDA) has released regulations on vaping products and electronic cigarettes (e-cigarettes). The European Monitoring Centre on Drugs and Drug Abuse (EMCDDA) released its "European Drug Report" which found a rise in ectasy and synthetic cannabis use in European Union member states.

This section offers news briefs on relating to addiction as of June 2016. It announces the implementation of the Cigarettes and Other Tobacco Products (Packaging and Labelling) Amendment Rules 2014 in India. It reports the prescription drug monitoring to be introduced in Victoria to prevent overdoses, as well as the ruling by the Texas Supreme Court upholding a state Supreme Court decision to impose a special tax on cigarette makers.

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]

Background No medications have been proven to be effective for cocaine and methamphetamine addiction. Attenuation of drug reward has been the main strategy for medications development, but this approach has not led to effective treatments. Thus, there is a need to identify novel treatment targets in addition to the brain reward system. Aim To propose a novel treatment strategy for stimulant addiction that will focus on medications enhancing cognitive function and attenuating drug reward. Methods Pre-clinical and clinical literature on potential use of cognitive enhancers for stimulant addiction pharmacotherapy was reviewed. Results and conclusions Cocaine and methamphetamine users show significant cognitive impairments, especially in attention, working memory and response inhibition functions. The cognitive impairments seem to be predictive of poor treatment retention and outcome. Medications targeting acetylcholine and norepinephrine are particularly well suited for enhancing cognitive function in stimulant users. Many cholinergic and noradrenergic medications are on the market and have a good safety profile and low abuse potential. These include galantamine, donepezil and rivastigmine (cholinesterase inhibitors), varenicline (partial nicotine agonist), guanfacine (alpha2-adrenergic agonist) and atomoxetine (norepinephrine transporter inhibitor). Future clinical studies designed optimally to measure cognitive function as well as drug use behavior would be needed to test the efficacy of these cognitive enhancers for stimulant addiction. [ABSTRACT FROM AUTHOR]

Background Diversion of methadone outside treatment programs occurs, yet reasons for use of ‘street methadone’ are characterized poorly. Self-medication for withdrawal symptoms is one plausible hypothesis. Among HIV-infected drug users, some antiretroviral medications can reduce potency of methadone, yet any association between such effects and the use of supplemental methadone sources remains undetermined. Objective To estimate the frequency and risk factors for use of street methadone. Methods Injection drug users (IDUs) recruited through extensive community outreach in 1988–89 and 1994 were followed semi-annually with questionnaires about health history, use of licit and illicit drugs including methadone and HIV-related assays. Analyses were performed using generalized estimating equation logistic regression. Results Of 2811 IDUs enrolled and eligible for analysis, 493 people reported use of street methadone over 12 316 person-years of follow-up (4.0/100 person-years). In multivariate analyses, street methadone use was more common among women, whites, those 40–59 years old, those who reported withdrawal symptoms, past methadone program attendance (6–12 months before visit), recent heroin injection with or without cocaine (but not cocaine alone), smoking or sniffing heroin and reported trading sex. Street methadone was not associated with HIV infection or treatment. Conclusion The results suggest that older IDUs still using heroin may be using street methadone to treat signs of withdrawal. The absence of a higher rate of street methadone use in HIV seropositive IDUs reveals that antiretroviral/methadone interactions are not a primary determinant of use outside of treatment settings. [ABSTRACT FROM AUTHOR]

Aims To systematically investigate the effectiveness of voucher-based reinforcement therapy for the treatment of substance use disorders. Methods Effect sizes and 95% confidence intervals were calculated for studies published between January 1991 and March 2004 that utilized voucher-based reinforcement therapy (VBRT) or related monetary-based incentives to treat substance use disorders (SUDs). Findings Thirty studies involved interventions targeting abstinence from drug use using experimental designs where effects on treatment outcome could be attributed to the VBRT intervention. The estimated average effect size (r) for those studies was 0.32 (95% CI 0.26–0.38). Analyses of variables thought to moderate VBRT effect sizes revealed that more immediate voucher delivery and greater monetary value of the voucher were associated with larger effect sizes. Additional studies were identified wherein VBRT was used to target clinic attendance ( n = 6) or medication compliance ( n = 4). VBRT studies targeting attendance produced average effect sizes of 0.15 (95% CI 0.02–0.28), while those that targeted medication compliance produced an average effect of 0.32 (95% CI 0.15–0.47). No significant moderators were identified for these 10 studies. Conclusions Overall, VBRT generated significantly better outcomes than did control treatments. These results further support the efficacy of VBRT, quantify the magnitude of its effects, identify significant moderators and suggest potential directions for future research. [ABSTRACT FROM AUTHOR]