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Introduction and Aims. To examine Australian opioid substitution treatment (OST) prescribers' perceptions of (i) diversion and/or injection of methadone, buprenorphine, buprenorphine-naloxone by patients; and (ii) effectiveness of current treatment policies in minimising the associated risks. Design and Methods. 1278 authorised OST prescribers, identified by each jurisdiction's health department records, were sent a postal survey in 2007. Reminder letters and additional copies of the survey were sent to non-responders at weeks four and eight following the initial mail-out. Respondents went into a draw to win one of ten $100 book vouchers. Results. Although the response rate was 26% (N = 291), participating prescribers served half (49%) of all OST patients in Australia. Prescribers perceived more buprenorphine patients removed supervised doses (7%) and diverted unsupervised doses (20%), compared with methadone patients (1% and 4% respectively) and buprenorphine- naloxone patients (3% and 2% respectively). Prescribers reported significantly more buprenorphine and buprenorphine- naloxone patients injected doses (5% respectively), compared with methadone patients (2%). Non-adherence was identified through patient self-report (51%), and the reports of pharmacists (49%) and other staff (34%). More prescribers were confident in assessing the risk of injection (54%) than diversion (37%). Many prescribers responded 'don't know' to quantitative survey items. Qualitative responses highlighted uncertainties in assessing diversion/injection and whether current responses constituted 'best practice'. Discussion and Conclusions. Australian prescribers perceive most patients adhere with OST, although they may underestimate the levels of diversion. Prescribers' beliefs about patients' behaviours are important and influence decisions to prescribe, medication choice and suitability for unsupervised dosing. The uncertainties in assessing and responding to diversion/injection may be a factor deterring prescribers' participation in OST. (Larance B, Degenhardt L, O'Brien S, Lintzeris N, Winstock A, Mattick RP, Bell J, Ali R. Prescribers' perceptions of the diversion and injection of medication by opioid substitution treatment patients. Drug Alcohol Rev 2011)

Background This study aimed to investigate patient perspectives regarding coming off maintenance opioid substitution treatment (OST). The study explored previous experiences, current interest and concerns about stopping treatment, and perceptions of how and when coming off treatment should be supported. Methods A cross-sectional survey was used. Participants were 145 patients receiving OST at public opioid treatment clinics in Sydney, Australia. Results Sixty-two percent reported high interest in coming off treatment in the next 6 months. High interest was associated with having discussed coming off treatment with a greater number of categories of people (OR=1.72), not citing concern about heroin relapse (OR=3.18), and shorter duration of current treatment episode (OR=0.99). Seventy-one percent reported previous withdrawal attempts and 23% had achieved opioid abstinence for ≥3 months following a previous withdrawal attempt. Attempts most commonly involved jumping off (59%), and doctor-controlled (52%) or self-controlled (48%) gradual reduction. For future attempts respondents were most interested in doctor-controlled (68%) or self-controlled (41%) gradual reduction. Concerns regarding coming off treatment included withdrawal discomfort (68%), increased pain (50%), and relapse to heroin use (48%). Conclusion While some patients may require lifetime maintenance, the issue of coming off treatment is important to many patients and should be discussed regularly throughout treatment and where appropriate supported by a menu of clinical options.

IntroductionChemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and flawed study design. Trials using cannabidiol-rich (CBD) products demonstrate improved efficacy and psychological adverse event profile. No definitive trials have been conducted to support the use of cannabinoids for this indication, nor has the potential economic impact of incorporating such regimens into the Australian healthcare system been established. CannabisCINV aims to assess the efficacy, safety and cost-effectiveness of adding TN-TC11M, an oral THC/CBD extract to guideline-consistent antiemetics in the secondary prevention of CINV.Methods and analysisThe current multicentre, 1:1 randomised cross-over, placebo-controlled pilot study will recruit 80 adult patients with any malignancy, experiencing CINV during moderate to highly emetogenic chemotherapy despite guideline-consistent antiemetics. Patients receive oral TN-TC11M (THC 2.5mg/CBD 2.5 mg) capsules or placebo capsules three times a day on day −1 to day 5 of cycle A of chemotherapy, followed by the alternative drug regimen during cycle B of chemotherapy and the preferred drug regimen during cycle C. The primary endpoint is the proportion of subjects attaining a complete response to CINV. Secondary and tertiary endpoints include regimen tolerability, impact on quality of life and health system resource use. The primary assessment tool is patient diaries, which are filled from day −1 to day 5. A subsequent randomised placebo-controlled parallel phase III trial will recruit a further 250 patients.Ethics and disseminationThe protocol was approved by ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences.Drug supplyTilray.Protocol version2.0, 9 June 2017.Trial registration numberANZCTR12616001036404; Pre-results.

Introduction and Aims.High-dose methadone has been associated with rate-corrected QT (QTc) prolongation and ‘torsade de pointes’. The Medicines and Healthcare products Regulatory Agency (MHRA) advise electrocardiograms (ECGs) for patients on methadone with heart/liver disease, electrolyte abnormalities, concomitant QT prolonging medications/CYP3A4 inhibitors or prescribed methadone >100 mg daily. The percentage of patients fulfilling MHRA criteria for ECG monitoring and prevalence of QT prolongation in patients who had an ECG was assessed. Design and Methods.A cross-sectional study of opioid-dependent patients prescribed opioid maintenance that completed a screening questionnaire prior to referral for an ECG. MHRA criteria were assessed in the referred group. The automated QTc score was analysed with methadone dose, substance use and QT risk factors. Results.Of 155 patients screened; 57.4% (n = 89) fulfilled MHRA criteria for ECG monitoring (75.5% (n = 117) if cocaine included as QT prolonging drug). Eighty-three (53.5%) had ECGs; 19.3% (n = 16) prescribed QT prolonging medication, 22.9% (n = 19) prescribed >100 mg methadone and 47% (n = 39) used cocaine. Mean QTc interval was 429.0 ms (SD 26.4, 351–489). Eighteen per cent exceeded QTc gender-specific thresholds (≥450 ms men and≥470 ms women). Linear regression found total daily methadone dose (β = 0.318, P = 0.003) and stimulant use (β = −0.213, P = 0.043) predictive of QTc length. Discussion.Over half to three-quarters of methadone maintenance patients fulfilled MHRA criteria for ECG monitoring, which has costly implications. QTc prolongation prevalence was 18.1% with no ‘clinically significant’ QTc prolongation >500 ms or torsade de pointes known to be present. Methadone dose and stimulant use were associated with longer QTc intervals. Further research on the clinical management of QTc prolongation with methadone is required.[Mayet S, Gossop M, Lintzeris N, Markides V, Strang J. Methadone maintenance, QTc and torsade de pointes: Who needs an electrocardiogram and what is the prevalence of QTc prolongation? Drug Alcohol Rev 2011;30:388–396]

Background: One of the major issues facing treatment services for alcohol and other drug users (current or ex-) around the world is community backlash, which has led to the closure of some much-needed drug treatment services. Aims: This study investigates the impact on the local community of a Medically Supervised Injectable Maintenance Clinic (MSIMC) implemented as part of the Randomised Injectable Opioid Treatment Trial (RIOTT), a trial into the effectiveness and efficacy of the provision of injectable opioids versus conventional oral methadone. The clinic model is based around a small number of the most entrenched and refractory patients (approx. 30) being treated by the service at any one time. Methods: The clinic and the trial were conceived primarily over 2002–2005, and the clinic began actual clinical operation in October 2005. The research was conducted between July 2005 and October 2007. Methods involved: pre-trial community key informant interviews; two-year follow-up key informant interviews; a...

Issues. There is a shortage of high-quality intervention-based evidence in the drug and alcohol misuse field. That is, evidence based on replicated effects using rigorous methodology, to establish a causal knowledge base around ethical, cost-effective methods relevant to clinical practice. The knowledge base in this field is limited participant recruitment challenges; difficulty generalising results from single-centre studies; lack of research culture; issues in managing research teams; incentives for descriptive research; and limited expertise in research design and working in multidisciplinary teams. Approach. An Australian national multicentre collaboration is proposed to overcome these barriers, and reduce the burden of drug and alcohol misuse by increasing the number of high-quality clinical trials in this field. It would involve: selecting a representative sample of centres nation-wide with expertise in specific drug and alcohol issues; creating an expert multidisciplinary team to facilitate clinical trials; simultaneous recruitment and implementation of clinical trials across centres; establishing a virtual infrastructure; forming an independent data-integrity and methodology review panel; and attracting and allocating funding for clinical trials. Implications. The ability to allocate funding, the involvement of multidisciplinary experts in drug and alcohol research, and the establishment of infrastructure and procedures are likely to result in the national multicentre group's capacity to prescribe the type of research conducted under its auspices. Conclusion. The proposed initiative is likely to increase the volume of high-quality clinical trials in the Australian drug and alcohol field, a key step towards reducing the burden of drug and alcohol misuse.[Sanson-Fisher R, Brand M, Shakeshaft A, Haber P, Day C, Conigrave K, Mattick R, Lintzeris N, Teesson M. Forming a national multicentre collaboration to conduct clinical trials: Increasing high-quality research in the drug and alcohol field. Drug Alcohol Rev 2010;29;469–474]

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IntroductionMethamphetamine dependence is a growing public health concern. There is currently no pharmacotherapy approved for methamphetamine dependence. Lisdexamfetamine (LDX) dimesylate, used in the treatment of attention-deficit hyperactivity disorder and binge eating disorder, has potential as an agonist therapy for methamphetamine dependence, and possible benefits of reduced risk of aberrant use due to its novel formulation.Methods and analysisA double-blind randomised controlled trial will be used to evaluate the efficacy of LDX in reducing methamphetamine use. The target sample is 180 participants with methamphetamine dependence of ≥2 years, using ≥14 days out of the previous 28, who have previously attempted but not responded to treatment for methamphetamine use. Participants will be randomly assigned to receive either a 15-week intervention consisting of induction (1 week of 150 mg LDX or placebo), maintenance (12 weeks of 250 mg LDX or placebo) and reduction (1 week of 150 mg LDX or placebo and 1 week of 50 mg LDX or placebo). All participants will be given access to four sessions of cognitive–behavioural therapy as treatment as usual and receive a 4-week follow-up appointment. The primary outcomes are efficacy (change from baseline in days of methamphetamine use by self-report for the last 28 days at week 13 and urinalyses confirmation of methamphetamine use) and safety (treatment-related adverse events). Secondary outcomes are total number of days of self-report methamphetamine use over the 12-week active treatment, longest period of abstinence during treatment period, percentage of achieving ≥21 days abstinence, craving, withdrawal, dependence, retention, bloodborne virus transmission risk behaviour, criminal behaviour, as well measures of abuse liability, physical and mental health, other substance use, cognitive performance, psychosocial functioning, treatment retention and satisfaction. Additionally, the study will assess the cost-effectiveness of LDX relative to the placebo control.Ethics and disseminationThe study has been approved by the Human Research Ethics Committee of St. Vincent’s Hospital, Sydney, Australia (HREC/16/SVH/222). Contact the corresponding author for the full trial protocol.Trial registration numberACTRN12617000657325; Pre-results.

Introduction and Aims: The use of opioid substitution therapy (OST) is a widely used and effective treatment for opioid dependence, yet many Australian general practitioners (GPs) authorised to administer OST, prescribe to very few or no patients. This is a particular issue within Victoria that places greater reliance on a small number of active OST prescribing GPs, compared with other jurisdictions. Given the unmet demand for treatment, the provision of accurate figures on the OST prescribing practices of Victorian GPs is necessary for workforce planning. This study aimed to ascertain information on the prescribing patterns ofVictorian GPs in their first 5 years after training, and elicit any trends that may explain their reluctance to prescribe OST. Design and Methods: The prescribing patterns over a 5 year period of 168 Victorian GPs who became first authorised to prescribe OST during the years 2001–2004 were examined by accessing the Victorian Department of Human Services OST individual patient treatment permit data. Results: Forty-six per cent of these GPs never held a patient permit, and at any one time, approximately two-thirds did not hold a permit.The majority of active prescribers were treating fewer than 10 patients and only 12.5% ever prescribed to more than 50 patients. Discussion and Conclusions: The study suggests the Victorian GP workforce is inadequate to address the demand for OST. Many more GPs will need to be recruited, and encouraged to prescribe for more patients. Further research is required to identify barriers to GP OST prescribing.

TPS10128Background: Up to half of patients receiving chemotherapy of moderate or high emetic risk experience CINV despite optimal anti-emetic prophylaxis. Limited evidence suggests cannabinoid medi...

Benzodiazepines (BZDs) are widely used by heroin users not in treatment, and by patients in methadone and buprenorphine (BPN) treatment. This review examines the epidemiology of BZD use by opioid users, and the range of harms that are associated with BZD use in this group, including the association of BZD use with opioid-related mortality. Preclinical and clinical data regarding pharmacokinetic and pharmacodynamic interactions between methadone, buprenorphine, and BZDs are reviewed. An overview of treatment approaches for managing BZD use in this population is presented, including strategies for minimizing abuse and addressing BZD dependence.

Objectives: To examine the levels and predictors of injection of buprenorphine– naloxone (BNX) — a combination of a partial opioid agonist and an opioid antagonist for treating opioid dependence — which was specifically developed to limit injecting. Comparison was made with injecting of two other opioid substitution treatment medications, methadone and buprenorphine (BPN); severe harms have been documented after injection of the latter. Design and participants: Injecting was studied in regular injecting drug users (“IDUs”) and current opioid substitution treatment clients (“clients”). Regular IDUs are interviewed annually in each Australian capital city (about 900 per year) and data for 2003–2007 were used; 399 clients were interviewed in 2007. Data on injection of opioid substitution treatment medications between 2003 and 2007 were adjusted for availability of medications (from national sales data for methadone, BPN and BNX). Predictors of injecting were analysed by multiple regression analyses. Setting: Capital cities of all Australian states and territories. Main outcome measure: Injection of opioid substitution treatment medications among individuals both in and out of treatment. Results: In the year after its introduction in Australia, BNX was injected less frequently and by fewer regular IDUs and clients compared with BPN, particularly when differences in the availability of medications were taken into account. Some individuals did nonetheless regularly inject BNX. Injection of methadone, BPN and BNX was more likely to occur among those injecting other pharmaceutical opioids. Conclusions: A partial opioid agonist–antagonist combination appears to be less commonly and less frequently injected by clients in treatment and IDUs who are not.

The study investigates patient preferences and beliefs and treatment program factors related to the decision to prescribe either buprenorphine or methadone to opiate-dependent patients. The sample (N = 192) was recruited from 10 addiction treatment services in London. Data were collected by means of a single structured interview conducted with patients commencing a treatment episode at the participating agencies. Data on patient demographics, beliefs, attitudes, and preferences were collected using a structured interview. Data regarding treatment goals and prescribed medication were collected from interviews with clinical staff. Oral methadone had a higher preference rating than buprenorphine. Clinical prescribing practices were influenced by patient preferences (both positive and negative), by prior treatment experiences, and by current treatment goals. Patient preferences and beliefs about opioid agonist medications served as an important influence upon clinical prescribing practices. The odds of being prescribed buprenorphine were three times greater among those patients who reported a preference for buprenorphine. The odds of receiving a prescription for methadone were about twice as great among those for whom methadone was the more preferred medication. Preferences were related to previous treatment experiences with these opioid agonists, and for patients in both groups, personal experience was the most important source of information about the treatment options. Buprenorphine was more likely to be prescribed for short-term detoxification and methadone for maintenance treatment.

Femoral (or groin) injecting is an emerging public health challenge to all drug-related services within the UK. Recent work in the area has proposed that groin injecting in the UK has moved from being a ‘risk boundary’ to an ‘acceptable behaviour’. This article uses data from 10 in-depth qualitative interviews with service users from a supervised injectable opiate treatment service in South London to report on pathways to, and reasons for, groin injecting. Our findings indicate that even though groin injecting constitutes a risk boundary for some injectors, the practice is no longer heavily stigmatised and is perceived by some to be an acceptable risk. Narratives also pointed to the importance of peers in the initiation of groin injecting. Interviewees described the groin as a site of ‘last resort’ in contrast to ‘convenience’ groin injectors described in some previous research. We conclude that it might be helpful to distinguish between convenience and last resort groin injectors and support the call for...

Background Femoral vein (or groin) injecting by street drug users is an emerging public health issue in the UK. It has been proposed that groin injecting is becoming normalised among UK injecting drug users (IDUs), yet harm reduction strategies are currently piecemeal and some may be crossing the boundary of responsible provision of information. This paper discusses the interventions available to service providers dealing with groin injecting and explores the utility of ethical frameworks for informing service provider decisions. Methods Methods analysis of possible service provider responses using White and Popovits' ethical decision-making framework. Results The use of ethical frameworks suggest that different types of groin injectors should receive different interventions. Injectors for whom the groin is a site of ‘last resort' should be given information about how to inject there less dangerously, whereas ‘convenience' groin injectors should be actively encouraged to inject elsewhere. Conclusion Groin injecting is a behaviour which represents a boundary for some harm reduction practices (such as providing ‘how to' booklets to all injectors) as well as being an argument for more complex and environmentally appropriate harm reduction responses such as drug consumption rooms and training IDUs to maintain healthier injecting sites.

Objective: To describe hospital presentations related to the use of naltrexone implants, an unlicensed product used in Australia for treating heroin dependence. Design: Retrospective case file audit. Setting: Two Sydney teaching hospitals. Patients: Identified through referrals to Drug and Alcohol Consultation-Liaison services over a 12-month period, August 2006 to July 2007. Main outcome measures: Diagnosis, management and duration of admission. Results: Twelve cases were identified: eight were definitely or probably related to naltrexone implants or the implantation procedure (rapid detoxification). Of these, six patients had severe opiate withdrawal and dehydration, with an average hospital stay of 2.3 days. One patient had an infection at the implant site, and one an underlying anxiety disorder requiring psychiatric admission. Three patients had analgesia complications, and one had unrelated cardiac arrhythmia. Conclusions: These severe adverse events challenge the notion that naltrexone implants are a safe procedure and suggest a need for careful case selection and clinical management, and for closer regulatory monitoring to protect this marginalised and vulnerable population.

Background Benzodiazepine abuse is common among methadone- and buprenorphine-maintained patients; however interactions between these drugs under high dose conditions have not been adequately examined under controlled conditions. Objective To investigate the effects of co-administering diazepam with methadone or buprenorphine under high dose conditions. Design Double-blind, randomly ordered, 2 × 2 cross-over design in which the effects of diazepam dose (0 mg versus 40 mg) and opioid dose (100% versus 150% normal dose) were examined over four sessions in methadone- and buprenorphine-maintained patients. Participants Four methadone- and seven buprenorphine-prescribed patients without concurrent dependence on other substances or significant medical co-morbidity. Measures Physiological (pulse rate, blood pressure, pupil size, respiratory rate and peripheral SpO 2 ), subjective (ARCI, VAS ratings) and performance (reaction time, cancellation task and Digit Symbol Substitution Test, DSST) measures were taken prior to and for 6 h post-dosing. Results High dose diazepam was associated with time-dependent increases in the intensity of subjective drug effects (strength of drug effect, sedation) and decreases in psychological performance (reaction time, DSST) for both methadone and buprenorphine patients. These effects were generally independent of the opioid dose administered. High dose opioid administration (150% normal dose) was associated with reductions in overall SpO 2 levels and performance (reaction time, DSST) in the methadone patients, but had virtually no impact on pharmacodynamic responses in the buprenorphine group. Conclusion High dose diazepam significantly alters subjective drug responses and psychological performance in patients maintained on methadone and buprenorphine.

Use of opioid agonist treatments for prescription opioid (PO) dependence is rapidly increasing. Current guidelines are based on research with heroin users. This study aimed to examine methadone and buprenorphine dose requirements for PO-dependent people.A retrospective case series of PO-dependent patients entering methadone and buprenorphine treatment. Daily oral morphine equivalent (OME) doses at baseline were calculated using standard dose conversion calculations. Dose conversion tables were used to estimate opioid agonist doses, based on starting dose of PO. Baseline methadone and buprenorphine dose at days 7 and 28 were examined. Linear models were fit to the data.Participants (n = 44) were 67% male, mean age 41 years (SD 10 years); 69% reported a pain condition. The methadone group (n = 21) had a mean PO dose of 704.5 mg OME (SD 783.5 mg) prior to treatment, and mean methadone dose of 45.3 mg (SD 13.1 mg) at day 7 and 61.6 mg (SD 20.8 mg) at day 28. The buprenorphine group (n = 23) had a mean PO dose of 771.7 mg OME (SD 867.7 mg) prior to treatment, with a mean dose of 14.6 mg (SD 8.3 mg) at day 7 and 18.1 (SD 8.9 mg) at day 28. Linear relationships were not found between OME and opioid agonist dose.Opioid agonist dosages varied substantially between individuals, and from predicted dosages based on dose conversion tables. Use of conversion tables to guide selection of opioid agonist dosage may compromise patient safety. [Nielsen S, Bruno R, Degenhardt L, Demirkol A, Lintzeris N. Opioid agonist doses for oxycodone and morphine dependence: Findings from a retrospective case series Drug Alcohol Rev 2017;36:311-316].

Sleep disturbance is a hallmark feature of cannabis withdrawal. In this study we explored the effects of lithium treatment supplemented with nitrazepam on objective and subjective measures of sleep quality during inpatient cannabis withdrawal.Treatment-seeking cannabis-dependent adults (n = 38) were admitted for 8 days to an inpatient withdrawal unit and randomized to either oral lithium (500 mg) or placebo, twice daily in a double-blind RCT. Restricted nitrazepam (10 mg) was available on demand (in response to poor sleep) on any 3 of the 7 nights. Dependent outcome measures for analysis included repeated daily objective actigraphy and subjective sleep measures throughout the 8 day detox, subjective cannabis withdrawal ratings, and detoxification completion rates.Based on actigraphy, lithium resulted in less fragmented sleep compared to placebo (p = 0.04), but no other objective measures were improved by lithium. Of the subjective measures, only nightmares were suppressed by lithium (p = 0.04). Lithium did not have a significant impact on the use of nitrazepam. Sleep bout length (p0.0001), sleep efficiency (p0.0001), and sleep fragmentation (p = 0.05) were improved on nights in which nitrazepam was used. In contrast, only night sweats improved with nitrazepam from the subjective measures (p = 0.04). A Cox regression with daily repeated measures of sleep efficiency averaged across all people in the study a predictor suggests that a one-unit increase in sleep efficiency (the ratio of total sleep time to the total time in bed expressed as a percentage) resulted in a 14.6% increase in retention in treatment (p = 0.008, Exp(B) = 0.854, 95% CI = 0.759-0.960). None of the other sleep measures, nor use of lithium or nitrazepam were significantly associated with retention in treatment.Lithium seems to have only limited efficacy on sleep disturbance in cannabis withdrawal. However the nitrazepam improved several actigraphy measures of sleep disturbance, warranting further investigation. Discord between objective and subjective sleep indices suggest caution in evaluating treatment interventions with self-report sleep data only.

The Australian Treatment Outcomes Profile (ATOP) is a brief instrument that assesses a range of substance use, health and well-being measures over the past 28 days. Previously, it has been validated in general adult Australian alcohol and other drug (AOD) treatment populations. However, the increasing number of older-aged clients attending AOD treatment warrants the instrument to be validated for this population. The aim of this study was to validate the ATOP for use in older AOD populations, by comparing it with validated 'gold standard' measures used in older populations.A convenience sample of 99 participants aged ≥50 attending specialist AOD services in Sydney, Australia were administered the ATOP by a researcher, along with alcohol use (AUDIT) and health questionnaires [Physical Health Questionnaire-15, 12-item short-form Health Survey (SF-12) and Geriatric Depression Scale].The ATOP items had strong agreement with the comparison instruments. The highest correlation was between the 28 days alcohol use and the AUDIT. ATOP psychological health scores highly correlated with the SF-12 mental health subscale and the Geriatric Depression Scale, and ATOP physical health scores significantly correlated with the SF-12 physical health subscale and the Physical Health Questionnaire-15. The ATOP Quality of Life score significantly correlated with all health measures. Discussion and Conclusions The ATOP has good concurrent validity with other validated substance use and health measures in an older population. Comparison with general older populations demonstrated the poorer health of this group of older AOD clients in particular.[Lintzeris N, Monds L A, Rivas G, Leung S, Withall A, Draper B. The Australian Treatment Outcomes Profile instrument as a clinical tool for older alcohol and other drug clients: A validation study. Drug Alcohol Rev 2016;35:673-677].

Opioid overdose prevention programs providing take-home naloxone have been expanding internationally. This paper summarises findings and lessons learnt from the Overdose Prevention and Emergency Naloxone Project which is the first take-home naloxone program in Australia implemented in a health care setting.The Project intervention provided education and take-home naloxone to opioid-using clients at Kirketon Road Centre and The Langton Centre in Sydney. The evaluation study examined uptake and acceptability of the intervention; participants' knowledge and attitudes regarding overdose and participants' experience in opioid overdose situations six months after the intervention. Participants completed baseline, post-training and follow-up questionnaires regarding overdose prevention and management which were analysed using repeated measures analysis of variance.Eighty-three people participated in the intervention, with 35 (42%) completing follow-up interviews-51% reporting using naloxone with 30 overdoses successfully reversed. There were significant improvements in knowledge and attitudes immediately following training with much retained at follow-up, particularly regarding feeling informed enough (97%) and confident to inject naloxone (100%).Take-home naloxone programs can be successfully implemented in Australian health settings. Barriers to uptake, such as lengthy processes and misperceptions around interest in overdose prevention, should be addressed in future program implementation.

STUDY OBJECTIVES: To examine sleep disturbances in the POINT cohort study consisting of participants prescribed long-term opioids for chronic noncancer pain (CNCP), and to examine the relationship between sleep and measures of pain, physical and mental health, substance use, and medication use at the baseline interview. METHODS: A convenience sample of 1243 participants with current CNCP and prescription opioid use were recruited from community settings and underwent a structured interview examining subjective sleep symptoms (Medical Outcomes Study [MOS] Sleep Scale and the Sleep Problems Index [SLP-9]), the pain severity and interference using the Brief Pain Inventory (BPI), mental and physical health symptoms, and recent substance and medication use. Linear regression models assessed independent predictors of SLP-9 scores. RESULTS: The median hours of sleep per night was 6 (IQR, 5 to 7.5), with 26% reporting optimal sleep (7 to 8 hours), and a mean SLP-9 score of 47.3 (SD=20.9). In multivariate analysis, age, frequent/severe headaches, BPI pain severity and pain interference scores, moderate to severe anxiety or depression, daily tobacco use, and benzodiazepine use in the past week were significant predictors of SLP-9 scores and sleep quality. Higher MOS respiratory impairment was observed in men, in those with a high body mass index, frequent/severe headaches, and high pain interference scores, and in patients taking anticonvulsants and antipsychotic medications. Opioid use was not associated with SLP-9 or respiratory sleep impairment. CONCLUSIONS: High levels of sleep problems were reported in this community sample of CNCP patients prescribed long-term opioids, and were associated with mental health problems and increased medication use. Nonmedication approaches to addressing sleep problems should be prioritized in this population.

There is increasing concern about the appropriateness of prescribing pharmaceutical opioids for chronic non-cancer pain (CNCP), given the risks of problematic use and dependence. This article examines pharmaceutical opioid dose and dependence and examines the correlates of each.Baseline data were obtained from a national sample of 1,424 people across Australia (median 58 years, 55% female and experiencing pain for a median of 10 years), who had been prescribed opioids for CNCP. Current opioid consumption was estimated in oral morphine equivalent (OME; mg per day), and ICD-10 pharmaceutical opioid dependence was assessed using the Composite International Diagnostic Interview.Current opioid consumption varied widely: 8.8% were taking20 mg OME per day, 52.1% were taking 21-90 mg OME, 24.3% were taking 91-199 mg OME, and 14.8% were taking= 200 mg OME. Greater daily OME consumption was associated with higher odds of multiple physical and mental health issues, aberrant opioid use, problems associated with opioid medication and opioid dependence. A significant minority, 8.5%, met criteria for lifetime ICD-10 pharmaceutical opioid dependence and 4.7% met criteria for past year ICD-10 pharmaceutical opioid dependence. Multivariate analysis found past-year dependence was independently associated with being younger, exhibiting more aberrant behaviors and having a history of benzodiazepine dependence.In this population of people taking opioids for CNCP, consumption of higher doses was associated with increased risk of problematic behaviors, and was more likely among people with a complex profile of physical and mental health problems.

Background Early identification of problems is essential in minimising the unintended consequences of opioid therapy. This study aimed to develop a brief scale that identifies and quantifies recent aberrant behaviour among diverse patient populations receiving long-term opioid treatment. Method 40 scale items were generated via literature review and expert panel ( N = 19) and tested in surveys of: (i) N = 41 key experts, and (ii) N = 426 patients prescribed opioids >3 months (222 pain patients and 204 opioid substitution therapy (OST) patients). We employed item and scale psychometrics (exploratory factor analyses, confirmatory factor analyses and item-response theory statistics) to refine items to a brief scale. Results Following removal of problematic items (poor retest-reliability or wording, semantic redundancy, differential item functioning, collinearity or rarity) iterative factor analytic procedures identified a 10-item unifactorial scale with good model fit in the total sample ( N = 426; CFI = 0.981, TLI = 0.975, RMSEA = 0.057), and among pain (CFI = 0.969, TLI = 0.960, RMSEA = 0.062) and OST subgroups (CFI = 0.989, TFI = 0.986, RMSEA = 0.051). The 10 items provided good discrimination between groups, demonstrated acceptable test–retest reliability (ICC 0.80, 95% CI 0.60–0.89; Cronbach's alpha = 0.89), were moderately correlated with related constructs, including opioid dependence (SDS), depression and stress (DASS subscales) and Social Relationships and Environment domains of the WHO-QoL, and had strong face validity among advising clinicians. Conclusions The Opioid-Related Behaviours In Treatment (ORBIT) scale is brief, reliable and validated for use in diverse patient groups receiving opioids. The ORBIT has potential applications as a checklist to prompt clinical discussions and as a tool to quantify aberrant behaviour and assess change over time.

In April 2014, a tamper-resistant controlled-release oxycodone formulation was released in Australia. We aimed to determine whether there are latent classes of people who tamper with pharmaceutical opioids based on frequency of opioid and illicit drug use, the demographic and clinical profiles of these groups, and if there were changes in use and harms following the introduction.A prospective cohort of 606 people who regularly tamper with pharmaceutical opioids was interviewed January to March 2014 (Wave 1) and May to August 2014 (Wave 2). Latent class analysis identified groups based on non-prescribed opioid, illicit drug and prescribed opioid substitution therapy (OST) use at Wave 1. Regression models examined whether group membership predicted use and harms at Wave 2.Four groups were identified: frequent OST group (39%), mixed OST/heroin group (7%), infrequent pharmaceutical opioid and heroin group (44%) and frequent oxycodone group (25%). Compared with the frequent OST group, the infrequent pharmaceutical opioid/heroin group was more likely to report non-everyday pain and risky alcohol use, and the frequent oxycodone group had higher odds of homelessness. At Wave 2, oxycodone use decreased across groups (odds ratios (OR) ≤ 0.18, p 0.001, particularly for the frequent oxycodone group: OR ≤ 0.05, p 0.001), with reductions in days of use (g ≥ 0.35, p 0.050). Non-prescribed pharmaceutical opioid use, illicit drug use and harms remained stable or decreased.Despite heterogeneity among people who tamper with pharmaceutical opioids, the tamper-resistant formulation was followed by reductions in oxycodone tampering among high-frequency and low-frequency users. There was no evidence of increased use of other opioids or illicit drugs.

Codeine dependence is an emerging public health concern, yet no studies have specifically examined the treatment of codeine dependence. Given the lower potency of codeine it cannot be assumed that buprenorphine dose requirements for heroin dependence will generalise to codeine. This is the first study to examine buprenorphine treatment for codeine dependence.Retrospective case series of 19 codeine-dependent treatment entrants who received sublingual buprenorphine maintenance treatment through six specialist inpatient and outpatient treatment centres. Baseline codeine doses and buprenorphine dose at days 7 and 28 were collected, in addition to details on general demographics, pain and mental health, substance use and outcomes after 28 days of buprenorphine treatment.A significant linear relationship was found between initial codeine dose and dose of buprenorphine given at days 7 and 28 for the codeine dose range of 50-960 mg dayWith increasing presentations relating to codeine dependence, these findings provide important guidance to clinicians. Buprenorphine doses were consistently higher than doses estimated based on the dose of codeine consumed, and were comparable with doses used in the treatment of dependence with heroin and more potent prescription opioids. [Nielsen S, Bruno R, Murnion B, Dunlop A, Degenhardt L, Demirkol A, Muhleisen P, Lintzeris N. Treating codeine dependence with buprenorphine: Dose requirements and induction outcomes from a retrospective case series in New South Wales, Australia. Drug Alcohol Rev 2015].

Cannabis is a common recreational drug that is generally considered to have low addictive potential. However, an increasing number of cannabis users are seeking treatment for dependence on the drug. There is interest in using agonist (substitution) pharmacotherapies to treat cannabis dependence and here we outline a novel approach involving a buccal spray (nabiximols) that contains tetrahydrocannabinol (THC) and cannabidiol (CBD). We review recent research with nabiximols and highlight findings relevant to clinical practice.

We report 2 years of post-marketing surveillance of the diversion and injection of buprenorphine-naloxone (BNX) film following its introduction in 2011.Interviews were conducted with people who inject drugs regularly (PWID) (2004-2013), opioid substitution therapy clients (2013, n = 492) and key experts (n = 44). Key outcomes were unsanctioned removal of supervised doses, diversion, injection and street price. Prevalence of past 6-month injection among PWID was adjusted for background availability of opioid substitution therapy medications using sales data.Among out-of-treatment PWID, the levels of regular (weekly+) BNX film injection were comparable to methadone and BNX tablets, and lower than mono-buprenorphine, adjusting for background availability. Fewer BNX film clients [3%; 95% (CI) 1-5] regularly injected their medication than mono-buprenorphine clients (25%; 95% CI 11-39), but at levels equivalent to those among methadone (3%; 95% CI 1-6) and BNX tablet clients (2%; 95% CI 0-6). Key experts perceived BNX film needed less supervised dosing time as it dissolved rapidly and was harder to remove from the mouth than sublingual tablets; however, removal of supervised doses was higher among BNX film clients (15%; 95% CI: 10-20) than methadone clients (3%; 95% CI 1-6), and not significantly different from BNX tablet (11%; 95% CI 2-21) and mono-buprenorphine clients (31%; 95% CI 16-46).Two years post-introduction, levels of BNX film diversion and injection remained comparable with those for methadone and BNX tablets, and lower than mono-buprenorphine. We found no evidence that BNX film has lower non-adherence and diversion than the tablet formulation. [Larance B, Mattick R, Ali R, Lintzeris N, Jenkinson R, White N, Kihas I, Cassidy R, Degenhardt L. Diversion and injection of buprenorphine-naloxone film two years post-introduction in Australia. Drug Alcohol Rev 2015].

Objectives: To assess the health status of heroin users starting and following 3 months of pharmacotherapy for opioid dependence, and to compare outcomes to a range of other chronic medical illnesses treated with maintenance medication. Methods: The study uses pooled data from 6 clinical trials included in an Australian National Evaluation of Pharmacotherapies for Opioid Dependence. Participants received maintenance pharmacotherapy (oral naltrexone treatment, methadone, or buprenorphine) for the treatment of heroin dependence. Participants’ health status was measured using the Short Form 36 health survey completed before treatment and at 3-month follow-up. Baseline data from 326 heroin-dependent participants starting maintenance treatment, and 3-month follow-up data for the 117 participants retained in trial treatment are presented. Results: Heroin users at entry into pharmacotherapy for opioid dependence were in very poor psychological and physical health in relation to Australian population norms. For the 117 participants retained in treatment, clinically and statistically significant improvements in physical health, and emotional and social health were observed in just 3 months. Importantly, the health status of treated heroin users improves to a comparable or greater degree than that observed with other chronic illnesses treated with maintenance medication. Conclusions: Existing,evidence-basedpharmacotherapiesshould be used in the treatment of heroin dependence with the same long-term care and medical monitoring strategies currently used in the treatment of other chronic illnesses.

An intranasal (IN) diamorphine spray was investigated as a possible alternative to injectable diamorphine for maintenance treatment. Plasma morphine and 6-monoacetylmorphine (6MAM) concentrations and pharmacodynamic responses were measured for 4 h following intravenous (IV) and IN administration of 40 mg diamorphine in 4 patients prescribed injectable diamorphine. The two routes were primarily differentiated by the significantly greater speed and magnitude of peak plasma morphine and 6MAM concentrations for IV versus IN diamorphine. Beyond this initial peak, mean ratings suggested that withdrawal suppression and positive effects were at least as strong for IN compared to IV administration. All subjects gave favourable appraisals of the IN diamorphine spray, citing advantages including ease of use, the avoidance of needle hazards, and reduced stigma. IN administration may be an alternative or supplementary form of diamorphine maintenance and deserves serious further investigation.

Aim To develop and evaluate a brief intervention for reducing risk behaviours associated with HCV transmission in injecting drug users (IDU). Design Randomized controlled trial of an individually tailored brief behavioural intervention (BBI) (experimental) versus a standardized educational intervention (control). Setting Specialist drug treatment facility in Melbourne, Australia. Participants One hundred and forty-five IDU (aged 18 or over, injecting at least weekly in the preceding 6 months) recruited and randomized to the experimental condition (n = 73) or the control condition (n = 72). Interventions The BBI was based on the Blood-Borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ)—a standardized blood-borne virus risk assessment instrument comprising injecting risk, sexual risk and other skin penetration risk subscales. The BBV-TRAQ was used to identify individual HCV risk practices and to tailor the 30-minute experimental BBI. Control participants received a standardized HCV educational session, using current educational materials. Main outcome measures BBV-TRAQ subscale and total scores and measures of participant satisfaction. Results One hundred and twenty-four participants (86%) were followed-up at 4 weeks (±7 days). Analyses revealed a significant reduction in HCV risk behaviours for both groups at 1-month follow-up, with participants in the experimental BBI condition reporting higher overall satisfaction with the intervention compared to the control group. Conclusions Both groups reported significant reductions in risk behaviour, indicating that while BBI methods hold promise for HCV education and prevention, they were not demonstrated to be more effective than the provision of standard educational materials. Future research could evaluate the efficacy of the BBV-TRAQ as a risk behaviour intervention and counselling tool in clinical, NSP and peer education settings.

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primary-care programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed.

This contribution focuses on the use of pharmacotherapies for the management of illicit drug use, specifically heroin and the stimulants cocaine and amphetamines. Treatment pathways for dependent drug users are shown in Figure 1.

Aims The present study aimed to compare the efficacy of levo-alpha-acetylmethadol (LAAM) and methadone, as measured by retention in treatment and heroin use, in a randomized trial conducted under naturalistic conditions. Setting This study is the first randomized trial comparing LAAM with methadone in the primary care setting. Participants were recruited through 29 medical practitioners working in specialist and generalist settings in Australia. Participants Existing methadone maintenance patients, aged 18 years and over and able to give informed consent, were randomized to receive either LAAM or methadone. A total of 93 patients participated. Intervention After being trained in the use of LAAM, existing methadone prescribers were then able to determine an individually tailored treatment regimen for each patient. The trial was an open-label study. Methadone and LAAM dosing was supervised through local community pharmacies. Participation in ancillary services (e.g. counselling) was optional for all patients. The treatment period for the trial was 12 months. Measurements Baseline, 3-, 6- and 12-month interviews were conducted. Outcome measures were retention in treatment, self-reported heroin use and serious adverse events. Findings There were no significant differences between LAAM and methadone on retention in treatment, nor heroin use. There was a trend for LAAM patients to have lower heroin use than methadone patients. of the seven serious adverse events in the LAAM group, three were not drug-related. There were two dosing errors. Conclusions This study demonstrates (a) the efficacy of LAAM as a treatment for heroin dependence, and (b) the capacity for LAAM to be effectively delivered in primary care settings by trained general practitioners and pharmacists. The next challenge is to resolve outstanding safety concerns with LAAM.

Objective: To compare outcomes, costs and incremental cost-effectiveness of heroin detoxification performed in a specialist clinic and in general practice. Design and setting: Randomised controlled trial set in a specialist outpatient drug treatment centre and six office-based general practices in inner city Sydney, Australia. Participants: 115 people seeking treatment for heroin dependence, of whom 97 (84%) were reinterviewed at Day 8, and 78 (68%) at Day 91. Interventions: Participants were randomly allocated to primary care or a specialist clinic, and received buprenorphine for 5 days for detoxification, then were offered either maintenance therapy with methadone or buprenorphine, relapse prevention with naltrexone, or counselling alone. Main outcome measures: Completion of detoxification, engagement in post-detoxification treatment, and heroin use assessed at Days 8 and 91. Costs relevant to providing treatment, including staff time, medication use and diagnostic procedures, with abstinence from heroin use on Day 8 as the primary outcome measure. Results: There were no significant differences in the proportions completing detoxification (40/56 [71%] primary care v 46/59 [78%] clinic), participating in postwithdrawal treatment (28/56 [50%] primary care v 36/59 [61%] clinic), reporting no opiate use during the withdrawal period (13/56 [23%] primary care v 13/59 [22%] clinic), and in duration of postwithdrawal treatment by survival analysis. Most participants in both groups entered postwithdrawal buprenorphine maintenance. On an intention-to-treat basis, self-reported heroin use in the month before the Day 91 interview was significantly lower than at baseline (27 days/month at baseline, 14 days/month at Day 91; P < 0.001) and did not differ between groups. Buprenorphine detoxification in primary care was estimated to be $24 more expensive per patient than treatment at the clinic. The incremental cost-effectiveness ratio reveals that, in this context, it costs $20 to achieve a 1% improvement in outcome in primary care. Conclusions: Buprenorphine-assisted detoxification from heroin in specialist clinic and primary care settings had similar efficacy and cost-effectiveness. Buprenorphine treatment can be initiated safely in primary care settings by trained GPs.

Background: Buprenorphine is used in the treatment of opioid dependence. Due to its pharmacology, the transfer from methadone to buprenorphine may precipitate withdrawal symptoms. Methods: Methadone maintained patients with clinical indicators of stability who were seeking withdrawal from methadone were recruited from three Australian states. Patients on methadone doses between 30 and 40 mg were randomised to transfer to buprenorphine by a fixed dose (transfer at 30 mg methadone) or by a variable dose induction (transfer when ‘uncomfortable’). A third group of patients with methadone doses less than 30 mg were transferred to buprenorphine at their entry methadone dose. Fifty-one patients were inducted onto buprenorphine using the same dosing protocol with the first dose of 4 mg buprenorphine. Following stabilisation on buprenorphine, patients gradually reduced the buprenorphine dose to 0 mg. Withdrawal severity and drug use was monitored. Results: There were no significant difference between the transfer at 30 mg and transfer when ‘uncomfortable’ dosing protocols in severity of withdrawal on transfer from methadone to buprenorphine. Those on doses less than 30 mg reported significantly less withdrawal discomfort at transfer. All but one patient stabilised on buprenorphine. Thirty-eight of the 51 patients inducted onto buprenorphine reached 0 mg. Conclusions: Transfer from methadone to buprenorphine can safely occur from doses of around 30 mg of methadone. Buprenorphine dose reductions were well tolerated. Thirty-one percent of patients were not using heroin or methadone at 1-month follow-up.

The study aimed to identify the range of buprenorphine doses required to comfortably alleviate symptoms in patients undergoing inpatient heroin withdrawal using a symptom-triggered titration dosing regime, and to identify the patient characteristics that impact upon the buprenorphine dose requirements. The study was conducted in two Australian inpatient withdrawal units, recruiting 63 dependent, injecting heroin users with no recent methadone treatment, dependence on other drugs, or other active medical or psychiatric conditions. In a single (patient) blinded case series, placebo or 2 mg sublingual buprenorphine tablets was administered four times a day according to severity of withdrawal (assessed with Subjective Opiate Withdrawal Scale). Up to 16 mg buprenorphine was available over the first 4 days of the admission, up to 8 mg on day 5, and placebo continued until day 6. Thirty-two subjects completed the dosing regime, with mean (+/-S.D.) daily doses of 3.8+/-2.8 on day 1, 5.8+/-3.2 on day 2, 4.8+/-3.3 on day 3, 2.3+/-2.6 on day 4, 0.8+/-1.3 on day 5, and a total dose of 17.4+/-9.7. Higher buprenorphine doses were required by those patients with more severe psychosocial dysfunction, women, those with more frequent heroin use, and those with more severe dependence on heroin at intake. A dosing regime using sublingual buprenorphine tablets for short inpatient heroin withdrawal is proposed.

Aims To develop a standard measure of blood-borne virus transmission risk behaviour, and examine the underlying psychometric properties. Design The Blood-borne Virus Transmission Risk Assessment Questionnaire (BBV-TRAQ) was developed over three consecutive phases of the original BBV-TRAQ study in adherence to classical scale development procedures, culminating in the recruitment of a development sample of current injecting drug users via convenience and snowball sampling. Setting Needle and syringe programmes (NSPs), medical clinics, alcohol/drug agencies, peer-based and outreach organizations across inner and outer metropolitan Melbourne. Participants Two hundred and nine current injecting drug users. The mean age was 27 years, 68% were male, 65% unemployed, 36% with prison history and 25% in methadone maintenance. Measurements BBV-TRAQ items cover specific injecting, sexual and skin penetration risk practices. BBV-TRAQ characteristics were assessed via measures of internal and test–retest reliability; collateral validation; and principal components analyses. Findings The BBV-TRAQ has satisfactory psychometric properties. Internal (a=0.87), test–retest (r=0.84) and inter-observer reliability results were high, suggesting that the instrument provides a reliable measure of BBV risk behaviour and is reliable over time and across interviewers. A principal components analysis with varimax rotation produced a parsimonious factor solution despite modest communality, and indicated that three factors (injecting, sex and skin penetration/hygiene risks) are required to describe BBV risk behaviour. Conclusions The BBV-TRAQ is reliable and represents the first risk assessment tool to incorporate sufficient coverage of injecting, sex and other skin penetration risk practices to be considered truly content valid. The questionnaire is indicated for use in addictions research, clinical, peer education and BBV risk behaviour surveillance settings.

Aim To determine whether buprenorphine is more effective than clonidine and other symptomatic medications in managing ambulatory heroin withdrawal. Design Open label, prospective randomized controlled trial examining withdrawal and 4-week postwithdrawal outcomes on intention-to-treat. Setting Two specialist, out-patient drug treatment centres in inner city Melbourne and Sydney, Australia. Participants One hundred and fourteen dependent heroin users were recruited. Participants were 18 years or over, and with no significant other drug dependence, medical or psychiatric conditions or recent methadone treatment. One hundred and one (89%) participants completed a day 8 research interview examining withdrawal outcomes, and 92 (81%) completed day 35 research interview examining postwithdrawal outcomes. Interventions Participants randomized to control ( n = 56) (up to 8 days of clonidine and other symptomatic medications) or experimental ( n = 58) (up to 5 days of buprenorphine) withdrawal groups. Following the 8-day withdrawal episode, participants could self-select from range of postwithdrawal options (naltrexone, substitution maintenance, or counselling). Measurements Retention in withdrawal; heroin use during withdrawal; and retention in drug treatment 4 weeks after withdrawal. Secondary outcomes Withdrawal severity; adverse events, and heroin use in the postwithdrawal period. Findings The experimental group had better treatment retention at day 8 (86% versus 57%, P = 0.001, 95% CI for numbers needed to treat (NNT) = 3‐8) and day 35 (62% versus 39%, P = 0.02, 95% CI for NNT = 4‐18); used heroin on fewer days during the withdrawal programme (2.6 ± 2.5 versus 4.5 ± 2.3, P < 0.001, 95% CI = 1‐2.5 days) and in the postwithdrawal period (9.0 ± 8.2 versus 14.6 ± 10, P < 0.01, 95% CI = 1.8‐9.4); and reported less withdrawal severity. No severe adverse events reported. Conclusions Buprenorphine is effective for short-term ambulatory heroin withdrawal, with greater retention, less heroin use and less withdrawal discomfort during withdrawal; and increased postwithdrawal treatment retention than symptomatic medications.

This study aimed to establish a buprenorphine regime suitable for the short-term management of out-patient heroin withdrawal using an open-label, single-group case series. Eighteen dependent injecting heroin users underwent an 8-day withdrawal episode with supervised dosing of sublingual Subutex tablets. Buprenorphine doses were titrated daily over a 5-day period. Fifteen subjects (83%) completed the 5-day regime, and 14 (78%) completed the 8-day withdrawal episode. The mean doses ((SD) were 6.1 (1.2) mg on day 1; 9.6 (1.7) mg on day 2; 10.1 (1.9) mg on day 3; 8.9 (2.0) mg on day 4; 4.1 (1.5) mg on day 5; and a total regime dose of 38.9 (5.8) mg. Withdrawal severity was mild, with minimal rebound upon the cessation of dosing. Five subjects reported no heroin use, and five subjects reported using on only one occasion during the 8 days. An out-patient buprenorphine regime is recommended.

Clinical Question Are different opioid agonist treatments (eg, methadone vs buprenorphine) associated with differences in efficacy for treating prescription opioid dependence, and is long-term maintenance of opioid agonist treatment associated with differences in efficacy compared with opioid taper or psychological treatments alone? Bottom Line For patients who are dependent on prescription opioids, long-term maintenance of opioid agonists is associated with less prescription opioid use and better adherence to medication and psychological therapies for opioid dependence compared with opioid taper or psychological treatments alone. Methadone maintenance was not associated with differences in therapeutic efficacy compared with buprenorphine maintenance treatment. Evidence quality was low to moderate.

Summary Background Classification of patients with pharmaceutical opioid use disorder and dependence varies depending on which definition is used. We compared how WHO's ICD-10 and proposed ICD-11 and the American Psychiatric Association's DSM-IV and DSM-5 classified individuals in a community-based sample of Australians with chronic non-cancer pain for which opioids have been prescribed. Methods We studied participants in the Pain and Opioid IN Treatment (POINT) cohort, a 2 year prospective cohort study of 1514 people prescribed pharmaceutical opioids for their chronic pain who were recruited in 2012–13 from community-based pharmacies across Australia. After giving patients the Composite International Diagnostic Interview about their opioid use, we assessed which patients would be categorised as having disorders of pharmaceutical opioid use by ICD-10, the draft ICD-11, DSM-IV, and DSM-5. We examined agreement between classification systems, and tested the unidimensionality of the syndrome with confirmatory factor analysis. Findings We included 1422 participants (median time of pain disorder 10 years [IQR 5–20]; median length of strong opioid prescription 4 years [IQR 1·5–10·0]; mean age 58 years). Similar proportions of individuals met lifetime criteria for dependence with DSM-IV (127; 8·9%), ICD-10 (121; 8·5%), and ICD-11 (141; 9·9%). Criteria in DSM-5 classified 127 (8·9%) participants with moderate or severe use disorder. There was excellent agreement between ICD-10, ICD-11 and DSM-IV dependence (κ>0·90). However, there was only fair to moderate agreement between ICD-10 and DSM-IV dependence diagnoses, and DSM-5 use disorder (mild, moderate, or severe). There was only good agreement between moderate to severe use disorder in DSM-5 and the other definitions. Criteria for all definitions loaded well on a single factor; the best model fit was for the definition for dependence in the draft ICD-11, the worst was in DSM-5. Interpretation Classification of problematic pharmaceutical opioid use varies across editions of ICD and DSM. The much lower levels of agreement between DSM-5 and other definitions than between other definitions might be attributed to DSM-5 containing an increased number of criteria and treating dependence and problematic use as a continuum. The more parsimonious ICD-11 dependence definition showed excellent model fit and excellent agreement with previous classificatory systems. Funding Australian National Health and Medical Research Council.

Background There is increasing debate about cannabis use for medical purposes, including for symptomatic treatment of chronic pain. We investigated patterns and correlates of cannabis use in a large community sample of people who had been prescribed opioids for chronic non-cancer pain. Methods The POINT study included 1514 people in Australia who had been prescribed pharmaceutical opioids for chronic non-cancer pain. Data on cannabis use, ICD-10 cannabis use disorder and cannabis use for pain were collected. We explored associations between demographic, pain and other patient characteristics and cannabis use for pain. Results One in six (16%) had used cannabis for pain relief, 6% in the previous month. A quarter reported that they would use it for pain relief if they had access. Those using cannabis for pain on average were younger, reported greater pain severity, greater interference from and poorer coping with pain, and more days out of role in the past year. They had been prescribed opioids for longer, were on higher opioid doses, and were more likely to be non-adherent with their opioid use. Those using cannabis for pain had higher pain interference after controlling for reported pain severity. Almost half (43%) of the sample had ever used cannabis for recreational purposes, and 12% of the entire cohort met criteria for an ICD-10 cannabis use disorder. Conclusions Cannabis use for pain relief purposes appears common among people living with chronic non-cancer pain, and users report greater pain relief in combination with opioids than when opioids are used alone.

Background:We aimed to determine the rates of alcohol and substance use in geriatric hospital and community health settings, and to evaluate the performance of screening instruments.Method:A two-phase cross-sectional study was undertaken in geriatric and aged care psychiatry wards and associated community services of a teaching hospital. Participants were screened with the Brief Alcohol Use Disorders Identification Test (AUDIT-C) and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) for other substances; Geriatric Depression Scale-15 for mood; the Connor–Davidson Resilience Scale; and the Subjective Quality of Life scale. Medical conditions were established. Screen positives for risky substance use continued with the full AUDIT, full ASSIST, CAGE, Addenbrooke's Cognitive Examination-Revised, and the Functional Activities Questionnaire. Medical records were reviewed after three months to ascertain recognition and management of substance use.Results:Of 210 participants aged 60+ (mean age 81.9, 63.3% female) without dementia or delirium and Mini Mental State Examination score ≥24, 41 (19.5%) were screen positive – 36 (17.1%) for alcohol, seven for non-medical benzodiazepine use (3.3%) (four alcohol and benzodiazepine) and two for non-medical opioid use (0.95%). Screen positives differed from screen negatives on few demographic or health measures. On the ASSIST, 26 (12.4%) were rated as medium/high risk. The AUDIT-C with cut-point of ≥5 was the optimal measure for detecting risky alcohol use.Conclusions:Many patients in geriatric health services have risky alcohol or substance use, but few clinical features distinguish them from other patients. Routine screening of alcohol and substance use is recommended.

Background There is increasing concern about tampering of pharmaceutical opioids. We describe early findings from an Australian study examining the potential impact of the April 2014 introduction of an abuse-deterrent sustained-release oxycodone formulation (Reformulated OxyContin®). Methods Data on pharmaceutical opioid sales; drug use by people who inject drugs regularly (PWID); client visits to the Sydney Medically Supervised Injecting Centre (MSIC); and last drug injected by clients of inner-Sydney needle-syringe programmes (NSPs) were obtained, 2009-2014. A cohort of n = 606 people tampering with pharmaceutical opioids was formed pre-April 2014, and followed up May-August 2014. Results There were declines in pharmacy sales of 80 mg OxyContin® post-introduction of the reformulated product, the dose most commonly diverted and injected by PWID. Reformulated OxyContin® was among the least commonly used and injected drugs among PWID. This was supported by Sydney NSP data. There was a dramatic reduction in MSIC visits for injection of OxyContin® post-introduction of the new formulation (from 62% of monthly visits pre-introduction to 5% of visits, August 2014). The NOMAD cohort confirmed a reduction in OxyContin® use/injection post-introduction. Reformulated OxyContin® was cheaper and less attractive for tampering than Original OxyContin®. Conclusions These data suggest that, in the short term, introduction of an abuse-deterrent formulation of OxyContin® in Australia was associated with a reduction in injection of OxyContin®, with no clear switch to other drugs. Reformulated OxyContin®, in this short follow-up, does not appear to be considered as attractive for tampering. Language: en

Buprenorphine-naloxone (BNX) film for opioid dependence treatment was introduced in Australia in 2011. A key difference in State policy approaches saw transfer from BNX tablets to BNX film mandated in South Australia (SA) with New South Wales (NSW) and Victoria (VIC) having less stringent policies. This study examined (i) how initiations and transfers were implemented, (ii) the profile and predictors of adverse effects as self-reported by BNX film clients, and (iii) dosing issues.Survey of 334 buprenorphine (BPN), BNX tablet and BNX film clients and semi-structured interviews with 39 key experts (KEs) in 2012. Comparisons are made between clients interviewed in SA versus NSW and VIC combined.Among the 180 current BNX film clients, 23% started treatment on BNX film, 18% requested a transfer to BNX film and 59% (n = 106) reported their clinic/prescriber recommended transfer to BNX film. Among clients who were offered but refused a transfer to BNX film (n = 66), the most common reason was 'I am happy with my current treatment and do not see a reason to change' (53%). Some opioid substitution therapy clients and KE viewed transfers as 'forced' (i.e. no choice of buprenorphine formulation). Multivariable regression showed residing in SA (vs. NSW/VIC) and a shorter length of current treatment episode were associated with more BNX film-attributed adverse effects but clinic/prescriber-recommended transfer was not.The introduction of BNX film in Australia varied across States. A perception of restricted choice in medication may have undermined initial acceptance in SA.