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Alcohol is a leading risk factor for death and disease in young people. We compare age-specific characteristics of young people who experience their first ('index') alcohol-related hospitalisation or emergency department (ED) presentation, and whether age at index predicts 12-month rates of readmission.We used a retrospective linked-data cohort of 10,300 people aged 12-20 years with an index alcohol-related hospital and/or ED record in New South Wales, Australia from 2005 to 2013. Age group (early adolescent [12-14 years], late adolescent [15-17 years], young adult [18-20 years]) and diagnosis fields were used in logistic regression analyses and to calculate incidence rates with adjustment for year of index event, sex, socioeconomic disadvantage and residence remoteness.People who experienced their index event in early adolescence (adjusted relative risk ratio [ARRR] 0.45 [95% confidence interval 0.39, 0.52]) or late adolescence (ARRR 0.82 [0.74, 0.90]) were less likely to be male compared to young adults. Early adolescents (ARRR 0.60 [0.51, 0.70]) and late adolescents (ARRR 0.84 [0.76, 0.93]) were less likely to have a hospitalisation index event. Early adolescents (adjusted incidence rate ratio 1.40 [1.15, 1.71]) and late adolescents (adjusted incidence rate ratio 1.16 [1.01, 1.34]) were more likely than young adults to have a subsequent 12-month non-poisoning injury ED presentation.We identified preventable hospital events in young people who have previously experienced an alcohol-related ED presentation or hospitalisation, with age-specific characteristics and outcomes that can be used to inform future health policy and service planning.

Objective: The present study aimed to characterise the intersecting sociodemographic, psychiatric and substance use needs of young people seeking treatment across multiple primary mental health, justice and alcohol and drug services within Australia. Methods: Data from four separate studies (N = 867) that investigated social and emotional wellbeing in young people aged 16-25-years-old were used in the present study (three studies recruited service users; one study recruited community participants) Results: The sociodemographic characteristics of service users differed substantially to the community sample. Service users identified as non-binary, LGBTIQ+ and Aboriginal and/or Torres Strait Islander at substantially greater proportions compared to the community sample. Family violence, involvement in criminal justice, homelessness and child protection services was considerably more common among service users than in the community sample and nearly one-third of service users were disengaged from opportunities for learning and vocational attainment. With respect to psychiatric characteristics, the majority of service users had been diagnosed with two or more psychiatric disorders and, almost two- thirds reported engagement in non-suicidal self- injury across their lifetime. Service users engaged in lower rates of lifetime and harmful alcohol use compared to the community sample; however, they reported significantly higher rates of lifetime and harmful drug use with more than one-third of service users engaged in poly-substance use. Conclusion: The comprehensive examination of the sociodemographic, psychiatric and substance use characteristics of young service users in the present study highlights the intersection of early childhood adversity, adolescent mental ill-health, polysubstance use and psychosocial vulnerabilities across multiple determinants of social and emotional wellbeing. The cohort were indeed representative of some of the most vulnerable in our society. The need for developmentally informed, inter-sectoral systems of care that address the intersecting vulnerabilities of these young Australian service users are discussed

We aimed to evaluate the impact of the Pathways to Comorbidity Care (PCC) training program for alcohol and other drugs (AOD) clinicians to improve the management of comorbidity. Methods: A controlled before-and-after study using PCC training was conducted across 6 matched sites in Australia including 35 clinicians. Controls received standard workplace training. PCC training included seminar presentations, workshops conducted by local "clinical champions," individual clinical supervision, and access to an online information portal. We examined (a) identification (screening, assessment) and treatment (treatment, referral) of comorbidity in practice (N = 10 clinical files per clinician), (b) self-efficacy, knowledge, and attitudes of clinicians. Results: Significant improvements were observed in the PCC group but not the control sites with regards to the rate of clinical files showing identification of comorbidity (+50% v -12% change from baseline, respectively; [X2 (1, N = 340) = 35.29, p = .01] with only a trend for improvements in the rate of files demonstrating treatment of comorbidity [X2 (1, N = 340) = 10.45, p = .06]. There were significant improvements in the PCC relative to the control group for clinician self-efficacy, F(1,33) = 6.40, p = .02 and knowledge and attitudes of comorbidity monitoring, F(1,33) = 8.745, p = .01. Conclusions: The PCC training package may help improve identification of comorbidity, self-efficacy, and attitudes toward screening and monitoring of comorbidity in drug and alcohol settings.

BACKGROUND AND AIMS Up to 95% of pregnant women seeking treatment for alcohol and other drug (AOD) use smoke tobacco. Previous reviews indicate few effective smoking cessation treatments for this group. This updated review aimed to identify and measure the efficacy of smoking cessation interventions trialled among pregnant women in AOD treatment settings who smoke tobacco. METHODS A narrative synthesis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Studies involving psychological, behavioural or pharmacological interventions used to treat tobacco use, including electronic nicotine delivery systems, for pregnant women of any age, who smoked tobacco and were seeking/receiving treatment, or in post-treatment recovery for AOD concerns, were reviewed. MEDLINE, PsycINFO, CINAHL, EMBASE and ProQuest databases, grey literature and reference lists were searched, and field experts were contacted for unpublished study data. The Effective Public Health Practice Project tool assessed study quality. The review was pre-registered with PROSPERO no. CRD42018108777. RESULTS Seven interventions (two randomised controlled trials, two single-arm pilot studies, two program evaluations and one causal comparative study) treating 875 women were identified. All were United States (US)-based and targeted women with drug dependence, but not alcohol dependence. Three interventions used contingency management, five provided behavioural counselling, and one offered nicotine replacement therapy. All reported reductions in cigarette consumption; one contingency management-based study demonstrated higher abstinence rates compared with controls at treatment-end that were not maintained at follow-up. Four of six studies were rated as methodologically weak and one unpublished study was not rated. CONCLUSIONS Conclusions about the efficacy of smoking interventions for pregnant women with alcohol and other drug concerns who also smoke tobacco are hindered by the paucity of available data and poor methodological quality of included studies.

There is no effective treatment for methamphetamine withdrawal. This study aimed to determine the feasibility and safety of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine (MA) withdrawal.Open-label, single-arm pilot study, in an inpatient drug and alcohol withdrawal unit assessing a tapering dose of oral lisdexamfetamine dimesylate commencing at 250 mg once daily, reducing by 50 mg per day to 50 mg on Day 5. Measures were assessed daily (days 0-7) with 21-day telephone follow-up. Feasibility was measured by the time taken to enrol the sample. Safety was the number of adverse events (AEs) by system organ class. Retention was the proportion to complete treatment. Other measures included the Treatment Satisfaction Questionnaire for Medication (TSQM), the Amphetamine Withdrawal Questionnaire and craving (Visual Analogue Scale).Ten adults seeking inpatient treatment for MA withdrawal (9 male, median age 37.1 years [IQR 31.7-41.9]), diagnosed with MA use disorder were recruited. The trial was open for 126 days; enroling one participant every 12.6 days. Eight of ten participants completed treatment (Day 5). Two participants left treatment early. There were no treatment-related serious adverse events (SAEs). Forty-seven AEs were recorded, 17 (36%) of which were potentially causally related, all graded as mild severity. Acceptability of the study drug by TSQM was rated at 100% at treatment completion. Withdrawal severity and craving reduced through the admission.A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting.

BACKGROUND AND AIMS: Opioid agonist treatment is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings world-wide. This study assessed the safety of subcutaneous slow-release depot buprenorphine in custody. SETTING: This is an open-label, non-randomized trial conducted in correctional centres in New South Wales, Australia. Sixty-seven men and women, aged ≥ 18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder currently serving a custodial sentence of ≥ 6 months were recruited between November 2018 and July 2019. Patients not in opioid agonist treatment at recruitment commenced depot buprenorphine; patients already stable on oral methadone treatment were recruited to the comparison arm. INTERVENTION AND COMPARATOR: Depot buprenorphine (CAM2038 weekly for 4 weeks then monthly) and daily oral methadone. Safety was assessed by adverse event (AE) monitoring and physical examinations at every visit. Participants were administered a survey assessing self-reported diversion and substance use at baseline and weeks 4 and 16. FINDINGS: Retention in depot buprenorphine treatment was 92.3%. Ninety-four per cent of patients reported at least one adverse event, typically mild and transient. No diversion was identified. The prevalence of self-reported non-prescribed opioid use among depot buprenorphine patients decreased significantly between baseline (97%) and week 16 (12%, odds ratio = 0.0035, 95% confidence interval = 0.0007-0.018, P

Introduction: The Australian Treatment Outcomes Profile (ATOP) is a brief instrument that measures self-reported substance use, health, and wellbeing in the previous 28 days for people in alcohol and other drug treatment. Previous studies have established the concurrent validity, inter-rater, and test-retest reliability of the tool. The current study sought to identify recommended cutoff scores for ATOP items for psychological health, physical health and quality of life that identify clients reporting clinically significant problems warranting further assessment and/or intervention, compared to cutoffs used by 'gold-standard' measures for these domains. Methods: Clients attending for treatment for problems with opioid (n = 144) or alcohol use (n = 134) completed the ATOP and comparison standardised questionnaires (Kessler-10, Short Form Survey 12 and the Personal Wellbeing Index) with a researcher. Receiver operating characteristics analysis, along with clinician perspectives, were used to recommend cutoff scores for ATOP items indicative of clinically significant problems. Results: A cutoff score of 5 or less out of 10 was identified as an optimal pragmatic cutoff for ATOP items relating to psychological health, physical health and quality of life items with regards to balancing sensitivity, specificity, and application in a treatment setting. Discussion and conclusions: The recommended clinical cutoffs will support clinicians and treatment services to identify clients who require further assessment and follow up for their psychological health, physical health and quality of life. The current study provides further evidence for the utility of the ATOP for individual clinical review, service planning and research.

Background and Aims The Australian Treatment Outcomes Profile (ATOP) is a brief instrument measuring recent substance use, risk profile and general health and wellbeing among clients attending alcohol and other drug (AoD) treatment services. This study evaluates the ATOP for concurrent validity, inter-rater and test–re-test reliability among alcohol and opioid treatment groups. Design For concurrent validity and inter-rater reliability, participants completed an ATOP with a clinician and an ATOP plus standardized questionnaires (time-line follow-back, Opiate Treatment Index, Kessler-10, 12-item Short Form Survey, World Health Organization Quality of Life-BREF, Personal Wellbeing Index) with a researcher within 3 days. For test–re-test reliability, participants completed two ATOPs with a researcher within a 3-day interval. Setting Outpatient AoD treatment centres in Australia. Participants For testing concurrent validity and inter-rater reliability, 278 participants were recruited by advertisements in waiting-rooms or clinician invitation during 2016 to 2018. A further 94 participants were recruited to examine test–re-test reliability. Measurements Statistical tests used for concurrent validity and test–re-test reliability were Pearson’s and Spearman’s rank order correlations for continuous variables, and Cohen’s κ for nominal variables. Inter-rater reliability was assessed using Krippendorf’s α. Findings Most Australian Treatment Outcomes Profile items returned excellent or moderate validity and reliability. For the main substances used—alcohol, cannabis and benzodiazepines—concurrent validity, inter-rater reliability and test–re-test reliability all reached excellent or good agreement (0.72–0.96). Psychological health, physical health and quality of life showed fair to strong agreement with their comparator scales (0.47–0.85). Conclusions The Australian Treatment Outcomes Profile is a validated and reliable instrument for assessing recent substance use and clinical risk, health and welfare among alcohol and opioid clients in alcohol and other drug treatment settings. Its ability to reliably measure complex constructs, such as psychological and physical health, against longer scales makes it suitable for integration into routine clinical care, enabling regular monitoring of patient outcomes and safety parameters.

A practice change intervention demonstrated improvements in the provision of antenatal care addressing alcohol consumption. The aim of this study was to explore whether the effectiveness of the intervention differed between subgroups of pregnant women and types and location of maternity services.Post-hoc exploratory subgroup analyses of the outcomes from a randomised stepped-wedge controlled trial conducted with all public maternity services within three sectors of a local health district in Australia.Two outcomes (receipt of alcohol assessment and complete care) measured at two visit types (initial and subsequent) were included in analyses. Logistic regression models explored interactions between pre-post differences and subgroups of women (age, Aboriginal origin, education level, disadvantage, gravidity and alcohol consumption in pregnancy) and services (geographic remoteness, service and provider type/s) that have been reported to be associated with variation in guideline implementation.Surveys from 5694 women were included in the analyses. For the initial visit, no significant differential intervention effects between subgroups of women or type/location of services were found for either outcome. For subsequent visits, the intervention effect differed significantly only between Aboriginal origin subgroups (Aboriginal OR: 1.95; 95% CI: 0.99-3.85; non-Aboriginal OR: 5.34; 95% CI: 4.17-6.83; p0.01) and women's alcohol consumption in pregnancy subgroups (consumed alcohol OR: 1.28; 95% CI: 0.59-2.78; not consumed alcohol OR: 5.22; 95% CI: 4.11-6.65; p0.001) for assessment of alcohol consumption.These exploratory results suggest that the intervention may have had similar effects between different subgroups of women and types and location of services, with the exception of women who were non-Aboriginal and women who had not consumed alcohol, for whom the intervention was potentially more effective.The practice change intervention could be implemented with different maternity service and provider types to effectively support improvements in antenatal care addressing alcohol consumption. These exploratory results provide further data for hypothesis generation regarding targeted areas for the testing of additional strategies that enable Aboriginal women to benefit equally from the intervention, and to ensure those women most in need of care, those consuming alcohol during pregnancy, have their care needs met.

Background Antenatal clinical practice guidelines recommend routine assessment of women’s alcohol consumption during pregnancy. The delivery of advice and referral when necessary are also recommended. However, evidence suggests there are barriers to the uptake of best-care guidelines. Effective, cost-effective and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised through addressing identified barriers. This paper describes the protocol for evaluating the efficiency and affordability of a practice change intervention compared to the usual practice in an implementation trial. Methods The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting. An economic evaluation will be conducted alongside the trial to assess intervention efficiency. A budget impact assessment will be conducted to assess affordability. The prospective trial-based economic evaluation will identify, measure and value key resource and outcome impacts arising from the multi-strategy practice change intervention compared with usual practice. The evaluation will comprise (i) cost-consequence analyses, where a scorecard approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial, and (ii) cost-effectiveness analyses, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for maternal alcohol consumption consistent with the guideline recommendations. Intervention affordability will be evaluated using budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fundholders. Results will be extrapolated to estimate the cost and cost-effectiveness of rolling out the model of care. Discussion Uptake of clinical guidelines requires practice change support. It is hypothesized that the implementation strategy, if found to be effective, will also be cost-effective, affordable and scalable. This protocol describes the economic evaluation that will address these hypotheses. Trial registration Australian and New Zealand Clinical Trials Registry, ACTRN12617000882325. Registered on 16 June 2017

INTRODUCTION AND AIMS: There is a need for detailed information on methamphetamine use in Aboriginal and Torres Strait Islander communities. We describe a national survey on methamphetamine use among Aboriginal and Torres Strait Islander people and non-Indigenous people. DESIGN AND METHODS: Participants aged 16 years or older who reported using methamphetamine in the past year were recruited for a cross-sectional survey through 10 Aboriginal Community Controlled Organisations. Surveys were completed anonymously on electronic tablets. Measures included the Australian Treatment Outcomes Profile, the Severity of Dependence Scale, subscales from Opiate Treatment Index and the Kessler 10. A Chronic Stress Scale was used to assess culturally situated chronic stress factors. RESULTS: Of the 734 participants, 416 (59%) were Aboriginal or Torres Strait Islander and 331 (45%) were female. In the previous year, most participants reported smoking (48.7%) or injecting (34%) methamphetamine and 17.4% reported daily use. Aboriginal and Torres Strait Islander people did not differ significantly from non-Indigenous participants on methamphetamine use patterns (age at first use, frequency of use, main mode of use, injecting risk, poly drug use). Aboriginal and Torres Strait Islander participants felt less able to access health care (32% vs. 48%, P < 0.001), including mental health services (19% vs. 29%, P < 0.002), were less likely to report a mental health diagnosis (50% vs. 60%, P < 0.002) and were more likely to turn to family for support (52% vs. 34%, P < 0.001). DISCUSSION AND CONCLUSIONS: We recruited and surveyed a large sample of Aboriginal and Torres Strait Islander people from which we can derive detailed comparative data on methamphetamine use and related health service needs for Aboriginal and Torres Strait Islander and non-Indigenous Australians.

Introduction and Aims: The Australian Treatment Outcomes Profile (ATOP) is a brief clinical tool measuring recent substance use, health and wellbeing among clients attending alcohol and other drug (AOD) treatment services. It has previously been assessed for concurrent validity and inter-rater reliability. In this study we examine whether it is suitable for administration over the telephone. Design and Methods: We recruited a sample of 107 AOD clients across public sector specialist AOD treatment services in New South Wales, Australia between 2016 and 2018. Participants had a mean age of 47 years and 46% were female. Participants completed a face-to-face ATOP and a phone ATOP with a researcher within 5 days. Comparisons between the two administration modes were undertaken using Spearman’s rank correlation coefficient for continuous or ordinal variables, and Cohen’s Kappa for nominal variables. Results. Among 107 participants, 59% were attending for alcohol treatment and 41% for opioid treatment. Most ATOP items (76%) reached above 0.7 (good) or 0.9 (excellent) agreement between face-to-face and telephone use. Discussion and Conclusions: Our findings suggest that the ATOP is a suitable instrument for telephone monitoring of recent substance use, health and social functioning among AOD clients. Its validation for remote use over the telephone will support staff to monitor clients’ risks and outcomes—of particular relevance in response to the COVID-19 pandemic in which services are increasingly relying on telework approaches to client monitoring.

Background The aim of this analysis was to calculate the incidence of hepatitis C virus (HCV) reinfection and associated factors among 2 clinical trials of HCV direct-acting antiviral treatment in people with recent injecting drug use or currently receiving opioid agonist therapy (OAT). Methods Participants who achieved an end-of-treatment response in 2 clinical trials of people with recent injecting drug use or currently receiving OAT (SIMPLIFY and D3FEAT) enrolled between March 2016 and February 2017 in 8 countries were assessed for HCV reinfection, confirmed by viral sequencing. Incidence was calculated using person-time of observation and associated factors were assessed using Cox proportional hazard models. Results Seventy-three percent of the population at risk of reinfection (n = 177; median age, 48 years; 73% male) reported ongoing injecting drug use. Total follow-up time at risk was 254 person-years (median, 1.8 years; range, 0.2–2.8 years). Eight cases of reinfection were confirmed for an incidence of 3.1/100 person-years (95% confidence interval [CI], 1.6–6.3) overall and 17.9/100 person-years (95% CI, 5.8–55.6) among those who reported sharing needles/syringes. Younger age and needle/syringe sharing were associated with HCV reinfection. Conclusions These data demonstrate the need for ongoing monitoring and improved strategies to prevent HCV reinfection following successful treatment among people with ongoing injecting drug use to achieve HCV elimination. Clinical Trials Registration NCT02336139 and NCT02498015.

Background Regular methamphetamine use is associated with increased rates of psychiatric symptoms. Although there has been a substantial body of research reporting on the effectiveness of psychological treatments for reducing methamphetamine use, there is a paucity of research examining the effects of these treatments on co-occurring psychiatric symptoms. We addressed this gap by undertaking a systematic review of the evidence of the effectiveness of psychological treatments for methamphetamine use on psychiatric symptom outcomes in randomized controlled trials. Methods A narrative synthesis of studies was conducted following the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement to inform methodology. Eight electronic peer-reviewed databases were searched. Ten eligible studies were assessed. Results Most studies found an overall reduction in levels of methamphetamine use and psychiatric symptoms among samples as a whole. Although brief interventions were effective, there is evidence that more intensive interventions have greater impact on methamphetamine use and/or psychiatric symptomatology. Intervention attendance was variable. Conclusions The evidence suggests that a variety of psychological treatments are effective in reducing levels of methamphetamine use and improving psychiatric symptoms. Future research should consider how psychological treatments could maximize outcomes in the co-occurring domains of methamphetamine use and psychiatric symptoms, with increasing treatment attendance as a focus. PROSPERO registration number: CRD42016043657.

AIM Aims were to test the effectiveness of an organizational change intervention integrating smoking cessation treatment into usual alcohol and other drug (AOD) treatment, compared with usual care, on (1) 7-day point prevalence abstinence (PPA) at 8 weeks follow-up; (2) prolonged abstinence; (3) cigarettes smoked per day; (4) number of quit attempts; and (5) offer and use of nicotine replacement therapy (NRT). All outcomes were assessed at 8 weeks and 6.5 months follow-up. DESIGN Cluster-randomized controlled trial, with AOD service as unit of randomization, conducted January 2015-March 2016. SETTING Thirty-two eligible services (provided face-to-face client sessions to ≥ 50 clients/year) in Australia were randomized to control (usual care; n = 15) or intervention (n = 17) groups by an independent blinded biostatistician. PARTICIPANTS Eligible participants (≥ 16 years, current smoker) completed surveys at the service at baseline (n = 896) and telephone follow-up surveys (conducted by blinded assessors) at 8 weeks (n = 471; 53%) and 6.5 months (n = 427; 48%). INTERVENTION Intervention services received an intervention to establish routine screening, assessment and delivery of smoking cessation care. MEASUREMENTS Primary outcome was biochemically verified 7-day PPA at 8-week follow-up. Secondary outcomes included verified and self-reported prolonged abstinence, self-reported 7-day PPA, cigarettes/day, quit attempts and offer and use of NRT. Intention-to-treat analyses were performed, assuming missing participants were not abstinent. FINDINGS At 8 weeks, the findings in verified 7-day PPA between groups [2.6 versus 1.8%, odds ratio (OR) = 1.72, 95% confidence interval (CI) = 0.5-5.7, P = 0.373] were inconclusive as to whether a difference was present. Significantly lower mean cigarettes/day were reported in the intervention group compared to the usual care group at 8 weeks [incidence rate ratio (IRR) = 0.88, 95% CI = 0.8-0.95, P = 0.001] but were similar at 6.5 months (IRR = 0.96, 95% CI = 0.9-1.02, P = 0.240) follow-up. At both follow-ups the intervention group reported higher rates of NRT use. CONCLUSIONS Integrating smoking cessation treatment into addiction services did not significantly improve short-term abstinence from smoking.

Background Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Methods A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 – May 2020) outcome data were collected from randomly selected women post an initial, 27–28 weeks and 35–36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness. Results Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women’s reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26–3.05; p p p p Conclusions The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support. Trial registration Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true

Evidence regarding the acceptability of contingency management is limited. We investigated the willingness of people who inject drugs to participate in a randomised controlled trial (RCT) involving financial incentives to initiate HCV treatment.ETHOS Engage is an observational cohort study of people with a history of injecting drug use who either injected in the past six months or receive opioid agonist therapy (OAT) in Australia. We assessed willingness to participate in a RCT with financial incentives and factors associated with preference for entire incentive ($60) at first clinic visit versus delayed incentive with logistic regression.93% (593/635) of eligible participants agreed to participate in an RCT with financial incentives of which 24% were Aboriginal or Torres Strait Islander, 84% had completed secondary school, and 59% injected drugs in the prior month. Willingness to participate in an RCT increased by amount offered: unspecified (72%), $20 (75%), $60 (80%), and $100 (85%). The preferred incentive distribution method over three clinical visits was entire incentive at first clinical visit (32%). Among those with a preferred distribution method (n = 369), factors associated with entire incentive at first clinic visit were being Aboriginal or Torres Strait Islander (aOR 1.75; 95% CI 1.05-2.94), completion of secondary school (aOR 0.46; 95% CI 0.26-0.83) and mainly injected heroin in month prior (aOR 1.82; 95% CI 1.03-3.20).Most participants were willing to participate in an RCT involving financial incentives to initiate treatment but differed regarding distribution. Study findings inform implementation of incentives in clinical practice.

Mood, sleep and pain problems are common comorbidities among treatment-seeking cannabis-dependent patients. There is limited evidence suggesting treatment for cannabis dependence is associated with their improvement. This study explored the impact of cannabis dependence treatment on these comorbidities.This is a secondary analysis from a 12-week double-blind placebo-controlled trial testing the efficacy of a cannabis agonist (nabiximols) against placebo in reducing illicit cannabis use in 128 cannabis-dependent participants. Outcome measurements including DASS-21 (Depression, Anxiety, and Stress subscales); Insomnia Severity Index (ISI); and Brief Pain Inventory (BPI), were performed at weeks 0, 4, 8, 12 and 24. Each was analysed as continuous outcomes and as binary cases based on validated clinical cut-offs.Among those whose DASS and ISI scores were in the moderate to severe range at baseline, after controlling for cannabis use, there was a gradual decrease in severity of symptoms over the course of the trial. BPI decreased significantly until week 12 and then rose again in the post-treatment period during weeks 12-24. Neither pharmacotherapy type (nabiximols vs placebo) nor number of counselling sessions contributed significant explanatory power to any of the models and were excluded from the final analyses for both continuous and categorical outcomes.Participants in this trial who qualified as cases at baseline had elevated comorbidity symptoms. There was no evidence that nabiximols treatment is a barrier to achieving reductions in the comorbid symptoms examined. Cannabis dependence treatment reduced illicit cannabis use and improved comorbidity symptoms, even when complete abstinence was not achieved.

Background Opioid agonist treatment (OAT) is an effective intervention for opioid dependence. Extended-release buprenorphine injections (BUP-XR) may have additional potential benefits over sublingual buprenorphine. This single-arm trial evaluated outcomes among people receiving 48 weeks of BUP-XR in diverse community healthcare settings in Australia, permitting examination of outcomes when BUP-XR is delivered in standard practice. Methods Participants were recruited from a network of specialist public drug treatment services, primary care and some private practices in three states. Following a minimum 7 days on 8–32 mg of sublingual buprenorphine (±naloxone), participants received monthly subcutaneous BUP-XR injections administered by a healthcare practitioner and completed monthly research interviews. The primary endpoint was retention in treatment at 48 weeks. Findings Participants (n = 100) were 28% women, mean age 44 years with a long history of OAT (median 5.8 years); heroin was the most common opioid of concern (58%). Treatment retention at 24 and 48 weeks was 86% and 75%, respectively. Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09–0.61) or heroin use (OR 0.23; 95%CI: 0.08–0.65) at baseline had lower odds of being retained in treatment to 48 weeks. Reductions in multiple forms of extra-medical drug use were observed. Improvements in quality of life, participation in employment, and treatment satisfaction measures were also observed. Interpretation This real-world implementation study of BUP-XR demonstrated high retention and treatment satisfaction. This study provides important additional data on the uptake and experience of clients, with relevance for policy makers, health service planners, administrators, and practitioners. Funding Indivior. Trial registration ClinicalTrials.gov Identifier: NCT03809143

Introduction Despite decreasing consumption by general populations, use of synthetic cannabinoid receptor agonists (SCRAs) persists in some marginalised groups, including those who use other substances. This article explores SCRA consumption in an Australian cannabis treatment sample, comparing those who report ever using SCRAs with those who have never used SCRAs. Methods A questionnaire orally administered in person to a convenience sample of 154 cannabis treatment service clients from New South Wales, Australia (71% male, median age 35) collected information regarding cannabis and SCRA use including motivations, effects and health-related consequences of use, demographics, other substance use and overall health. Demographic profiles and between-group differences were explored. McNemar tests compared effects of SCRA and cannabis. Logistic regression analysis determined predictors of SCRA use. Results Half (53%) reported lifetime SCRA use; 20% reported previous-month use. The SCRA + cannabis group displayed greater polysubstance use and psychological distress. Reduced dependence on cannabis but higher levels of other substance use may predict SCRA use. Although curiosity motivated initial SCRA consumption, perceived psychoactive strength drove continued use. SCRAs appear to induce more negative side-effects than cannabis. Of the SCRA + cannabis group, 27% sought medical assistance for SCRA use. Most (90%) preferred cannabis to SCRAs, citing superior safety, effects and consistency of cannabis. Conclusions Among clients seeking treatment for cannabis use, SCRA use was relatively common, although not a preferred substance. Hazardous substance use and poor mental health characterised SCRA consumers, highlighting the need for continued monitoring by researchers and treatment providers of SCRA consumption in populations who use substances.

Background Implementation of antenatal clinical guideline recommendations for addressing maternal alcohol consumption is sub-optimal. There is a complete absence of evidence of the cost and cost-effectiveness of delivering practice change interventions addressing maternal alcohol consumption amongst women accessing maternity services. The study sought to determine the cost, cost-consequence and cost-effectiveness of developing and delivering a multi-strategy practice change intervention in three sectors of a health district in New South Wales, Australia. Methods The trial-based economic analyses compared the costs and outcomes of the intervention to usual care over the 35-month period of the stepped-wedge trial. A health service provider perspective was selected to focus on the cost of delivering the practice change intervention, rather than the cost of delivering antenatal care itself. All costs are reported in Australian dollars ($AUD, 2019). Univariate and probabilistic sensitivity analyses assessed the effect of variation in intervention effect and costs. Results The total cost of delivering the practice change intervention across all three sectors was $367,646, of which $40,871 (11%) were development costs and $326,774 (89%) were delivery costs. Labour costs comprised 70% of the total intervention delivery cost. A single practice change strategy, ‘educational meetings and educational materials’ contributed 65% of the delivery cost. Based on the trial’s primary efficacy outcome, the incremental cost effectiveness ratio was calculated to be $32,570 (95% CI: $32,566–$36,340) per percent increase in receipt of guideline recommended care. Based on the number of women attending the maternity services during the trial period, the average incremental cost per woman who received all guideline elements was $591 (Range: $329 - $940) . The average cost of the intervention per eligible clinician was $993 (Range: $640-$1928). Conclusion The intervention was more effective than usual care, at an increased cost. Healthcare funders’ willingness to pay for this incremental effect is unknown. However, the strategic investment in systems change is expected to improve the efficiency of the practice change intervention over time. Given the positive trial findings, further research and monitoring is required to assess the sustainability of intervention effectiveness and whether economies of scale, or reduced costs of intervention delivery can be achieved without impact on outcomes. Trial registration The trial was prospectively registered with the Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

Background Antenatal clinical guidelines recommend that during initial and subsequent antenatal visits all pregnant women: have their alcohol consumption assessed; be advised that it is safest not to consume alcohol during pregnancy and of the potential risks of consumption; and be offered referrals for further support if required. However, the extent to which pregnant women attending public antenatal services receive guideline recommended care at these visits, and the characteristics associated with its receipt, is unknown. The purpose of this study was to examine: 1) pregnant women’s reported receipt of guideline recommended care addressing alcohol consumption during pregnancy; 2) characteristics associated with the receipt of care; and 3) pregnant women’s acceptability of care. Methods From July 2017 – February 2018 a survey (telephone or online) was undertaken with 1363 pregnant women who had recently visited a public antenatal service in one health district in Australia. Receipt and acceptability of recommended care were assessed via descriptive statistics and associations via logistic regression analyses. Results At the initial antenatal visit, less than two thirds (64.3%) of pregnant women reported that they received an assessment of their alcohol consumption and just over one third (34.9%) received advice and referral appropriate to their self-reported level of alcohol consumption since pregnancy recognition. Less than 10% of women received such care at subsequent antenatal visits. Characteristics that significantly increased the odds of receiving all guideline elements at the initial antenatal visit included: less than university attainment (OR = 1.93; 95% CI:1.12, 3.34), not residing in an advantaged area (OR = 2.11; 95% CI:1.17, 3.79), first pregnancy (OR = 1.91; 95% CI:1.22, 2.99) and regional/rural service location (OR = 2.38; 95% CI:1.26, 4.48); and at subsequent visits: younger age (OR = 0.91; 95% CI:0.84, 0.99) and Aboriginal origin (OR = 3.17; 95% CI:1.22, 8.24). Each of the recommended care elements were highly acceptable to pregnant women (88.3–99.4%). Conclusions Although care for alcohol consumption is both recommended by clinical guidelines and highly acceptable to pregnant women, its receipt in public antenatal services is suboptimal. There is a need and an opportunity for interventions to support antenatal care providers to routinely and consistently provide such care to all pregnant women.

Background: Direct-acting antiviral therapy for hepatitis C virus (HCV) infection is safe and effective, but there are little data among people who have recently injected drugs. This study evaluated the efficacy, and safety of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for chronic HCV genotype (G) 1 among people with recent injecting drug use and/or receiving OST. Methods: D3FEAT is an international open-label study that recruited treatment-naive participants with recent injecting drug use (previous 6 months) and/or receiving OST with chronic HCV G1 infection between June 2016 and February 2017 in seven countries. Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir with (G1a) or without ribavirin (G1b) administered twice daily in a one-week electronic blister pack (records timing of each dose) for 12 weeks. The primary endpoint was undetectable HCV RNA 12 weeks post-treatment (SVR12). Results: Among 87 participants (median age 48 years), 23% were female, 8% had cirrhosis, and 90% had G1a. Overall, 71% were receiving OST, 61% injected in the previous six months, 45% injected in the previous month, and 15% injected > daily. Treatment completion was 97% (84 of 87). There were no virological breakthroughs, but three discontinuations (loss to follow-up, n = 1; non-adherence, n = 1; incarceration, n = 1). SVR was 91% (79 of 87, 95% CI, 83%–96%). Five participants who completed treatment did not have SVR (loss to follow-up, n = 1; death, n = 1; virologic relapse, n = 3). Drug use prior to and during treatment did not impact SVR12. Treatment-related adverse events were observed in 46 (53%) patients (six grade 3, no grade 4). Five (6%) patients had at least one serious adverse event (two possibly/probably related to therapy; nausea and myoclonus). Two cases of reinfection were observed. Conclusion: Paritaprevir/ritonavir, ombitasvir, and dasabuvir with or without ribavirin for 12 weeks is effective among people with HCV genotype 1 with recent injecting drug use and/or receiving OST.

BACKGROUND This study investigated treatment adherence among people with recent injecting drug use in a study of sofosbuvir/velpatasvir therapy for HCV infection. METHODS SIMPLIFY is an international open-label, single-arm multicentre study that recruited participants with recent injecting drug use (previous six months) and chronic HCV genotype (G) 1-6 infection between March and October 2016 in seven countries (19 sites). Participants received sofosbuvir/velpatasvir once-daily for 12 weeks administered in a one-week electronic blister pack (records the time and date of each dose) for 12 weeks. We evaluated non-adherence (

Introduction Vaporised nicotine products (VNPs) may be useful smoking cessation aids for people in alcohol and other drug (AOD) treatment, a population with high tobacco-related morbidity and mortality rates. This qualitative study aimed to examine the barriers and facilitators of using VNPs as part of a clinical trial to reduce or quit smoking among people in AOD treatment. Methods Thirteen people in AOD treatment who were participating in a trial of VNPs for smoking cessation (QuitENDs) completed a brief semi-structured interview examining experiences of using VNPs to reduce or quit smoking. Transcribed data was analysed using the iterative categorisation framework. Results Many participants expressed the benefit of having a smoking cessation aid that addressed nicotine cravings and the behavioural hand-to-mouth action to help them reduce or quit smoking. Although many participants reported that VNPs were easy to use, some found maintaining the device to be challenging. Some participants described Australian regulations limiting use of VNPs as reducing their desire to use the device as a cessation aid. Many participants attempting to reduce or quit tobacco and cannabis simultaneously stated that VNPs alone were insufficient to help them reduce or quit tobacco. Conclusions VNPs hold significant promise as smoking cessation aids among people in AOD treatment because of their unique ability to satisfy both nicotine cravings and behavioural habits. However, multiple barriers, such as accessibility, maintenance, and the challenges of reducing other substance use simultaneously also need to be addressed for optimal engagement in clinical trials with VNPs to quit smoking.

INTRODUCTION This paper aimed to document alcohol use during pregnancy and determine predictors of ongoing use, including knowledge and agreement with national alcohol guideline recommendations. METHODS Pregnant women (n = 1179) attending public antenatal services in a Local Health District in NSW, Australia, were surveyed about their alcohol use before pregnancy and after pregnancy recognition, and awareness of, and agreement with, national alcohol guidelines and health-related statements. Respondent characteristics, drinking behaviour and predictors of ongoing drinking during pregnancy were assessed. RESULTS Most women consumed alcohol before pregnancy (79.3%) but the majority (82.0%) stopped following pregnancy recognition. Half the ongoing drinkers only drank on special occasions. Most (63.6%) women were aware of the national guidelines: 78.1% knew the recommendation that consuming no alcohol in pregnancy is safest, 4.6% thought some alcohol was safe and 17.3% were unsure. Predictors [OR (95%CI)] of ongoing drinking were older age [1.11 (1.07, 1.15)]; medium [2.42 (1.46, 4.00)] or high-risk drinking pre-pregnancy [3.93 (2.35, 6.56)]; and agreement that: avoiding alcohol in pregnancy is safest [0.05 (0.006, 0.47)]; avoiding alcohol is important for baby's health [0.14 (0.06, 0.31)] and pregnancy is a good time to change alcohol use for mother's health [0.29 (0.13, 0.63)]. DISCUSSION AND CONCLUSIONS Results emphasise the importance of asking about special occasion drinking, the link between pre-pregnancy drinking and ongoing drinking during pregnancy, and the need to understand why women disagree with the national guideline. To ensure guidelines have their intended benefit, interventions to promote behaviour change relating to alcohol consumption during pregnancy are warranted.