When compared to remaining on a waitlist, take-home self-administered buprenorphine-naloxone treatment is associated with significant reductions in heroin use for people with DSM-IV-TR heroin dependence. This cost-effective approach may be an efficient strategy to enhance treatment capacity.

BackgroundThe cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches.Methods/DesignA phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment.Four specialist drug and alcohol outpatient clinics in New South Wales, Australia.One hundred forty-two treatment seeking cannabis dependent adults, with no significant medical, psychiatric or other substance use disorders.Nabiximols is an oromucosal spray prescribed on a flexible dose regimen to a maximum daily dose of 32 sprays; 8 sprays (total 21.6 mg tetrahydrocannabinol (THC) and 20 mg cannabidiol (CBD)) four times a day, or matching placebo, dispensed weekly. All participants will receive six-sessions of individual cognitive behavioural therapy (CBT) and weekly clinical reviews.Primary endpoints are use of non-prescribed cannabis (self-reported cannabis use days, urine toxicology), safety measures (adverse events and abuse liability), and cost effectiveness (incremental cost effectiveness in achieving additional Quality Adjusted Life Years). Secondary outcomes include, improvement in physical and mental health parameters, substance use other than cannabis, cognitive functioning and patient satisfaction measures.DiscussionThis is the first outpatient community-based randomised controlled study of nabiximols as an agonist replacement medication for treating cannabis dependence, targeting individuals who have not previously responded to conventional treatment approaches. The study and treatment design is modelled upon an earlier study with this population and more generally on other agonist replacement treatments (e.g. nicotine, opioids).Trial registrationAustralian and New Zealand Clinical Trial Registry: ACTRN12616000103460 (Registered 1st February 2016).Electronic supplementary materialThe online version of this article (10.1186/s12888-018-1682-2) contains supplementary material, which is available to authorized users.

IntroductionWhile tobacco smoking prevalence is falling in many western societies, it remains elevated among high-priority cohorts. Rates up to 95% have been reported in women whose pregnancy is complicated by other substance use. In this group, the potential for poor pregnancy outcomes and adverse physical and neurobiological fetal development are elevated by tobacco smoking. Unfortunately, few targeted and effective tobacco dependence treatments exist to assist cessation in this population. The study will trial an evidence-based, multicomponent tobacco smoking treatment tailored to pregnant women who use other substances. The intervention comprises financial incentives for biochemically verified abstinence, psychotherapy delivered by drug and alcohol counsellors, and nicotine replacement therapy. It will be piloted at three government-based, primary healthcare facilities in New South Wales (NSW) and Victoria, Australia. The study will assess the feasibility and acceptability of the treatment when integrated into routine antenatal care offered by substance use in pregnancy antenatal services.Methods and analysisThe study will use a single-arm design with pre–post comparisons. One hundred clients will be recruited from antenatal clinics with a substance use in pregnancy service. Women must be <33 weeks’ gestation, ≥16 years old and a current tobacco smoker. The primary outcomes are feasibility, assessed by recruitment and retention and the acceptability of addressing smoking among this population. Secondary outcomes include changes in smoking behaviours, the comparison of adverse maternal outcomes and neonatal characteristics to those of a historical control group, and a cost-consequence analysis of the intervention implementation.Ethics and disseminationProtocol approval was granted by Hunter New England Human Research Ethics Committee (Reference 17/04/12/4.05), with additional ethical approval sought from the Aboriginal Health and Medical Research Council of NSW (Reference 1249/17). Findings will be disseminated via academic conferences, peer-reviewed publications and social media.Trial registration numberAustralia New Zealand Clinical Trial Registry (Ref: ACTRN12618000576224).

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.

IntroductionThe prevalence of tobacco smoking in pregnancy remains elevated in some disadvantaged populations of women. One group is those who use alcohol and/or other psychoactive substances during pregnancy, with tobacco use prevalence estimates ranging from 71% to 95%. Although effective evidence-based cessation treatments exist, few women with co-occurring substance use problems successfully stop smoking during pregnancy. There is limited information about treatments that specifically target this group and a summary of the available research is required to assist and enhance the development of innovative cessation interventions. This article describes a protocol for a comprehensive review of studies that have trialled behavioural and/or pharmacological tobacco cessation interventions in populations of pregnant women who are nicotine dependent and use alcohol and/or other psychoactive substances.Methods and analysisThe review will undertake literature searches in MEDLINE, PsycINFO, CINAHL, EMBASE and ProQuest databases, as well as the grey literature. Studies of any design methodology will be included if they describe changes to tobacco smoking behaviours in quantitative terms. No restriction on year of publication or published language will apply. Participants include pregnant women of any age, who smoke tobacco, who are seeking or having treatment, or in post-treatment recovery for the use of psychoactive substances. Interventions are any psychological, behavioural or pharmacological treatments used to treat tobacco use. Outcome measures are any that quantitatively report abstinence or reductions in participant tobacco consumption. Key details and tobacco-related outcomes from included studies will be extracted and tabulated before being narratively synthesised. The systematic review protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines.Ethics and disseminationEthics approval is not required. Findings will be disseminated via peer-reviewed literature, conference presentations, media and social media.PROSPERO registration numberCRD42018108777