Technologies for Supporting Individuals and Caregivers Living With Fetal Alcohol Spectrum Disorder: Scoping Review.

Background: Fetal alcohol spectrum disorder (FASD) is a common developmental disability that requires lifelong and ongoing support but is often difficult to find due to the lack of trained professionals, funding, and support available. Technology could provide cost-effective, accessible, and effective support to those living with FASD and their caregivers. Objective: In this review, we aimed to explore the use of technology available for supporting people living with FASD and their caregivers. Methods: We conducted a scoping review to identify studies that included technology for people with FASD or their caregivers; focused on FASD; used an empirical study design; were published since 2005; and used technology for assessment, diagnosis, monitoring, or support for people with FASD. We searched MEDLINE, Web of Science, Scopus, Embase, APA PsycINFO, ACM Digital Library, JMIR Publications journals, the Cochrane Library, EBSCOhost, IEEE, study references, and gray literature to find studies. Searches were conducted in November 2022 and updated in January 2024. Two reviewers (CZC and HW) independently completed study selection and data extraction. Results: In total, 17 studies exploring technology available for people with FASD showed that technology could be effective at teaching skills, supporting caregivers, and helping people with FASD develop skills. Conclusions: Technology could provide support for people affected by FASD; however, currently there is limited technology available, and the potential benefits are largely unexplored.

Sexualised drug use among gay and bisexual men in New Zealand: Findings from a national cross-sectional study.

INTRODUCTION: New Zealand has a unique illicit drug market, gay cultures and drug use patterns. Minimal attention has been given to how drug use shapes sexual practice, especially in the era of biomedical HIV prevention among gay and bisexual men (GBM). METHODS: An online cross-sectional study of GBM ('Flux NZ') adapted from an Australian study was undertaken to explore connections between drug use, sexual practice, health and community. We describe drug use patterns, then identify three discrete groups determined by intensity of recent (past 6 months) sexual practice: no recent sex, recent sex and recent sexualised drug use. We examine factors associated with these groups and identify factors independently predicting sexualised drug use. RESULTS: Of 739 participants, almost a third had engaged in group sex (29%), 17.5% were taking pre-exposure prophylaxis (PrEP), 6.5% were HIV positive. Overall, 59.5% had recently used illicit drugs (16.9% methylenedioxymethamphetamine, 6% methamphetamine, 3.3% gamma-hydroxybutyrate acid, 1.4% ketamine). Sexualised drug use was common (35.7%). Those engaged in sexualised drug use were connected to gay community and had a high uptake of biomedical HIV prevention. Independent predictors of sexualised drug use included being sexually adventurous, knowing their HIV status, having more than 10 recent sexual partners, engaging in group sex and sex at a sex-on-site venue. DISCUSSION AND CONCLUSIONS: Many GBM engaging in sexualised drug use manage HIV transmission risks through regular testing, PrEP and HIV treatment. HIV prevention efforts should target GBM with less intensive sexual behaviour but who may be at comparatively higher risk of HIV transmission.

Adapting an Evidence-Based e-Learning Cognitive Behavioral Therapy Program Into a Mobile App for People Experiencing Gambling-Related Problems: Formative Study.

BACKGROUND: Many people who experience harm and problems from gambling do not seek treatment from gambling treatment services because of personal and resource barriers. Mobile health (mHealth) interventions are widely used across diverse health care areas and populations. However, there are few in the gambling harm field, despite their potential as an additional modality for delivering treatment and support. OBJECTIVE: This study aims to understand the needs, preferences, and priorities of people experiencing gambling harms and who are potential end users of a cognitive behavioral therapy mHealth intervention to inform design, features, and functions. METHODS: Drawing on a mixed methods approach, we used creators and domain experts to review the GAMBLINGLESS web-based program and convert it into an mHealth prototype. Each module was reviewed against the original evidence base to maintain its intended fidelity and conceptual integrity. Early wireframes, design ideas (look, feel, and function), and content examples were developed to initiate discussions with end users. Using a cocreation process with a young adult, a Maori, and a Pasifika peoples group, all with experiences of problem or harmful gambling, we undertook 6 focus groups: 2 cycles per group. In each focus group, participants identified preferences, features, and functions for inclusion in the final design and content of the mHealth intervention. RESULTS: Over 3 months, the GAMBLINGLESS web-based intervention was reviewed and remapped from 4 modules to 6. This revised program is based on the principles underpinning the transtheoretical model, in which it is recognized that some end users will be more ready to change than others. Change is a process that unfolds over time, and a nonlinear progression is common. Different intervention pathways were identified to reflect the end users' stage of change. In all, 2 cycles of focus groups were then conducted, with 30 unique participants (13 Maori, 9 Pasifika, and 8 young adults) in the first session and 18 participants (7 Maori, 6 Pasifika, and 5 young adults) in the second session. Prototype examples demonstrably reflected the focus group discussions and ideas, and the features, functions, and designs of the Manaaki app were finalized. Attributes such as personalization, cultural relevance, and positive framing were identified as the key. Congruence of the final app attributes with the conceptual frameworks of the original program was also confirmed. CONCLUSIONS: Those who experience gambling harms may not seek help. Developing and demonstrating the effectiveness of new modalities to provide treatment and support are required. mHealth has the potential to deliver interventions directly to the end user. Weaving the underpinning theory and existing evidence of effective treatment with end-user input into the design and development of mHealth interventions does not guarantee success. However, it provides a foundation for framing the intervention's mechanism, context, and content, and arguably provides a greater chance of demonstrating effectiveness.

Alcohol use trajectories across the life course: Influences of childhood predictors and consequences for late-life health.

BACKGROUND: The cumulative, negative health effects of alcohol consumption are exacerbated in older adulthood. We used a 'life course epidemiology' approach to explore how alcohol use trajectories develop across the lifespan, what early life events influence these trajectories and their associations with late-life health. METHODS: Survey data combined with retrospective life course history interviews were collected from 749 non-lifetime alcohol abstainer adults aged 61-81 years (51 % female). Frequency and quantity items of the AUDIT-C assessed alcohol use across each decade of life. Early life factors were childhood socioeconomic status, parental health behaviours, and age of drinking onset. Health outcomes were alcohol-related conditions. RESULTS: Latent class growth analysis yielded two life course trajectories for women: consistently infrequent, low quantity drinking (Group 1: 48 %) and increasingly frequent, low quantity drinking (Group 2: 52 %). Men showed three trajectories: consistently infrequent, low quantity drinking (Group 3: 36 %); increasingly frequent, low quantity drinking (Group 4: 51 %); and drinking with increasing frequency and quantity until midlife, after which consumption gradually declined (Group 5: 13 %). Better childhood socioeconomic status was associated with Groups 2 and 4. Later drinking onset was associated with Groups 1 and 3. Parental alcohol misuse, early drinking initiation and childhood socioeconomic adversity were predictive of Group 5. Those in Group 5 were five-to-seven times more likely to have alcohol-related comorbidities. CONCLUSIONS: Early life experiences influence life course hazardous alcohol use. Interventions across the life course, from childhood, when drinking may be initiated, through to older adulthood, when sensitivity to alcohol increases, are needed.

Ten-Year Trajectories of Alcohol Consumption in Older Adult New Zealanders.

OBJECTIVES: Older adults are often treated as a homogeneous drinking group, but research suggests that they engage with alcohol in various ways, ranging from abstention to heavy drinking. The study aimed to (i) identify subgroups of older adults based on changes in frequency and quantity of alcohol use over 10 years and (ii) examine co-occurring changes in mental and physical health. METHOD: Data were collected biennially between 2006 and 2016 from 2,632 New Zealanders (55-70 years old at baseline). Latent class growth analysis was performed to identify trajectories of alcohol use. Co-occurring changes in physical and mental health were examined using latent growth curve analysis. RESULTS: Five drinking profiles emerged: (i) infrequent, low-quantity consumers; (ii) highly frequent, low-quantity consumers; (iii) moderately frequent, high-quantity consumers; (iv) moderately frequent, low-quantity consumers; and (v) highly frequent, high-quantity consumers. Drinking trajectories demonstrated no change or slight declines in frequency and quantity over time. Frequent and moderately frequent, high-quantity drinking was more prevalent among men, younger participants, and active smokers. Moderately frequent, heavy drinkers were in very poor health. Frequent and moderately frequent, low-quantity drinking was associated with better health and economic well-being. Infrequent, low-quantity consumers were more likely to be women and in poor health. DISCUSSION: The five drinking profiles indicate that older adults engage with alcohol in diverse ways. Two of these patterns indicated potentially hazardous use, which highlights the need for screening and intervention in this age group.

Betel Nut Use in Vanuatu: Investigating Opportunities to Reduce Harms to Health.

Background: Betel nut chewing is a public health concern in the Asia-Pacific region and is an emerging issue in Vanuatu. Despite the significant health risks associated with betel nut chewing, few interventions have been undertaken to reduce its harm. Objectives: To investigate betel nut use in Vanuatu and to identify opportunities to reduce its harm and possible interventions, framing the responses using the World Health Organization's MPOWER tobacco control model. Method: Qualitative research design, in the form of semi-structured interviews with ten participants with expertise in health, agriculture, education or non-communicable disease in Port Vila, Vanuatu during June 2017. Recorded interviews were transcribed verbatim, and a general inductive approach was used to identify key themes. Results: Participants reported a recent increase in betel nut use in Vanuatu due to the influence from Papua New Guinea and the Solomon Islands. To reduce the harm of betel nut use in Vanuatu, participants suggested policies and strategies that aligned with the MPOWER framework that could be adopted for betel nut control, including restricting cultivation and sale of betel nut in Vanuatu and using radio and existing community networks to reach people with messages about the dangers of betel nut use. Conclusion: Betel nut use may be growing in popularity in Vanuatu, where there are potential policy options to minimize harm. The MPOWER model for tobacco control may be a useful framework to help the Vanuatu government to deliver a comprehensive approach to reducing harm from betel nut use.

E-learning: A Tool to Upgrade the Skills of Health Workers to Address Betel Quid and Areca Nut Chewing.

Background: In the Asia-Pacific region, betel quid and areca nut chewing is a public health concern that requires immediate attention. There is a need to improve knowledge about the harmful effects of betel quid and areca nut chewing and train health care professionals to provide preventive interventions. Objectives: To introduce and evaluate the Pacific Open Learning Health Net (POLHN) online courses about the dangers of betel quid and areca nut. Methods: Two self-paced courses about betel quid and areca nut chewing were developed and offered via the POLHN which predominantly engages health professional working in the Pacific islands. Students completing each of the courses were asked to complete a survey measuring course organization, content, length and comprehension level, evaluation methods, adaption to the Pacific island context, relevance to work and level of interaction. Conclusions: The POLHN courses about the dangers of betel quid and areca nut were well accepted by participants for quality and relevancy to their work. POLHN is the first platform that offers a course in betel quid and areca nut in the Pacific and has the potential to be adopted elsewhere.

Challenges of virtual talking therapies for substance misuse in New Zealand during the COVID-19 pandemic: an opinion piece.

The COVID-19 pandemic requires us to rethink how virtual approaches might work for people who use alcohol and other drugs. Are virtual clinics only suitable for clients with whom clinicians have already formed a therapeutic relationship? How well would virtual clinics work for new clients presenting to services, for clients in acute distress, and for those with complex problems? Addressing the sustained change required to maintain substance-free lives or a safe substance-use life requires robust psychotherapeutic approaches, which have traditionally been delivered through physical contact, whether they are one-to-one or group-based interventions. The challenge during this time of the COVID-19 pandemic is to deliver effective talking therapies while avoiding physical contact. How then should services continue to offer counselling and support in such an environment? How can we learn from the COVID-19 situation to deliver treatment to individuals who may have difficulties attending traditional clinic-based care, such as those in more rural areas with transport difficulties? This article focuses on identifying practical issues and providing some solutions.

Injecting drug use among gay and bisexual men in New Zealand: Findings from national human immunodeficiency virus epidemiological and behavioural surveillance.

INTRODUCTION AND AIMS: Gay and bisexual men (GBM) who inject drugs are disproportionately affected by human immunodeficiency virus (HIV) because of dual transmission risks. New Zealand has a progressive history of harm reduction and was the first country to publicly fund needle exchange programs in 1988 for people who inject drugs (PWID). We combine national HIV epidemiological and bio-behavioural surveillance data to understand HIV risk among this subpopulation. DESIGN AND METHODS: We examine trends in new HIV diagnoses 1996-2018 by mode of transmission, and compare HIV cases attributed to sex between men (MSM-only), MSM/injecting drug use (IDU) and IDU-only. IDU among GBM in a national HIV behavioural surveillance survey was also examined. We compare GBM by IDU status (never, 'recent', previous) and identified predictors of recent IDU. RESULTS: Of 1653 locally-acquired HIV diagnoses 1996-2018, 77.4% were MSM-only, 1.5% MSM/IDU, 1.4% IDU-only and 14.2% heterosexual mode of transmission. On average, just one HIV diagnosis attributed to MSM/IDU and IDU, respectively, occurred per annum. MSM/IDU cases were more likely than MSM-only cases to be indigenous Maori ethnicity. Of 3163 GBM survey participants, 5.4% reported lifetime IDU and 1.2% were recent IDU. Among GBM, HIV positivity was 20% among recent IDU and 5.3% among never injectors. Predictors of recent IDU were: age under 30; more than 20 male partners; female partner; condomless intercourse; HIV positivity. DISCUSSION AND CONCLUSION: New Zealand has averted high endemic HIV rates seen among GBM and PWID in other countries and results have been sustained over 30 years.

Manaaki - a cognitive behavioral therapy mobile health app to support people experiencing gambling problems: a randomized control trial protocol.

BACKGROUND: The low utilisation of current treatment services by people with gambling problems highlights the need to explore new modalities of delivering treatment interventions. This protocol presents the design of a pragmatic randomized control trial aimed at assessing the effectiveness and acceptability of cognitive behavioral therapy (CBT) delivered via a mobile app for people with self-reported gambling problems. METHODS: An innovative CBT mobile app, based on Deakin University's GAMBLINGLESS online program, has been adapted with end-users (Manaaki). Six intervention modules have been created. These are interwoven with visual themes to represent a journey of recovery and include attributes such as avatars, videos, and animations to support end-user engagement. An audio facility is used throughout the app to cater for different learning styles. Personalizing the app has been accomplished by using greetings in the participant's language and their name (e.g. Kia ora Tane) and by creating personalized feedback. A pragmatic, randomized control two-arm single-blind trial, will be conducted in New Zealand. We aim to recruit 284 individuals. Eligible participants are ≥18 years old, seeking help for their gambling, have access to a smartphone capable of downloading an app, able to understand the English language and are willing to provide follow-up information at scheduled time points. Allocation is 1:1, stratified by ethnicity, gender, and gambling symptom severity based on the Gambling Symptom Assessment Scale (G-SAS). The intervention group will receive the full mobile cognitive behavioural programme and the waitlist group will receive a simple app that counts down the time left before they have access to the full app and the links to the data collection tools. Data collection for both groups are: baseline, 4-, 8-, and 12-weeks post-randomisation. The primary outcome is a change in G-SAS scores. Secondary measures include changes in gambling urges, frequency, expenditure, and readiness to change. Indices of app engagement, utilisation and acceptability will be collected throughout the delivery of the intervention. DISCUSSION: If effective, this study will contribute to the improvement of health outcomes for people experiencing gambling problems and have great potential to reach population groups who do not readily engage with current treatment services. ETHICS APPROVAL: NZ Health and Disability Ethics Committee (Ref: 19/STH/204) TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry (ANZCTRN 12619001605189) Registered 1 November 2019.

The Lower-Risk Cannabis Use Guidelines (LRCUG): A ready-made targeted prevention tool for cannabis in New Zealand.

Cannabis use is common, especially among young people, and associated with risks for select acute and chronic adverse health and social outcomes. New Zealand features overall high cannabis use levels, yet may soon follow other jurisdictions and implement legalization of non-medical cannabis use and supply towards public health objectives. While existing cannabis-oriented interventions mainly focus on primary prevention and treatment (e.g., for dependence), key harms from use are crucially influenced by risk factors that can be modified by the user. On this basis, and similar to other health behavior-oriented interventions, 'Lower-Risk Cannabis Use Guidelines' (LRCUG), consisting of 10 recommendation clusters for lower-risk use, were systematically developed in Canada as an evidence-based, targeted prevention tool towards reducing adverse outcomes among cannabis users. We briefly summarize the concept of and experiences with implementation of the LRCUG elsewhere, and describe how their adoption as a population health intervention may serve public health goals of possible cannabis legalization in New Zealand and elsewhere.

Investigating Betel Nut Use, Antecedents and Consequences: A Review of Literature.

Background: Betel nut use is a public health issue in the Asia-Pacific region that is often neglected. To control betel nut use, understanding of the adverse effects of betel nut use and evidence-based policies and strategies is necessary. Objectives: This narrative review aims to characterize the current situation on betel nut use at a global level regarding the epidemiology, pharmacology and toxicology, health effects, treatment options, policies and strategies. Methods: We found 139 existing literature published between 1970-2019 on the Web of Science database and other technical documents to collate the most relevant information on betel nut use. Data were categorized into appropriate themes. Results: The literature demonstrates that there is a lack of up to date statistics on betel nut use. There is limited research on the effect of policies and strategies to control betel nut use. Conclusion: Betel nut-chewing countries should focus on understanding which populations chew betel nut and implement appropriate policies, educational and cessation programs to help control betel nut use.

Hazardous Drinking Prevalence and Correlates in Older New Zealanders: A Comparison of the AUDIT-C and the CARET.

Objectives: The study compared the proportion of older adults identified as drinking hazardously based on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) with the older adult-specific Comorbidity Alcohol Risk Evaluation Tool (CARET) and investigated whether sociodemographics, comorbidities, health, medication use, and alcohol-related risk behaviors explained discrepancies between the screens in classification of hazardousness. Method: The AUDIT-C and the CARET were administered to 3,673 adults aged 55 to 89 years. Classification agreement between the screens was evaluated using Cohen's kappa. Hazardous drinking groups were compared using logistic regression. Results: Analysis indicated moderate agreement between the screens. Drinkers classified as "hazardous on the CARET only" consumed less alcohol, but were more likely to drink-drive. Introducing a drink-driving criterion into the calculation of hazardousness on the AUDIT-C substantially decreased the classification discrepancy between the measures. Discussion: Standard screening can be improved by investigating comorbidities, medication use, and alcohol-related risk behaviors in those initially identified as nonhazardous drinkers.

Ascending single dose pharmacokinetics of cytisine in healthy adult smokers.

1. Cytisine, a partial agonist for the α4ß2-nAChR, is used as a smoking cessation medication. Cytisine's current dosing is complex and involves taking 1.5 mg several times a day. The aim of this study was to explore the effect of dose on the pharmacokinetics and safety of cytisine after a single dose in healthy adult smokers. 2. Participants were assigned to one of three groups (n = 6 in each group) to receive a single oral dose of 1.5, 3 or 4.5 mg of cytisine. Blood samples were collected up to 24 h post dose. Pulse, blood pressure and respiratory rate were measured. Adverse effects were recorded. 3. Cytisine reached peak plasma concentration 1-2 h post dose in all participants irrespective of dose, with no dose-dependent changes in the elimination phase. Mean (SD) cytisine exposure (AUC0-24h) were 81.9 (15.8), 181.9 (40.8) and 254.5 (48.1) ng.h/mL following 1.5, 3 and 4.5 mg, respectively. 4. Cytisine appears to have predictable pharmacokinetics following a single dose of up to 4.5 mg and may be safe given as a single 4.5 mg dose, which is threefold greater than the recommended dose taken at one time. This study is registered in ClinicalTrials.gov (ID:NCT02585024).

Methylenedioxymethamphetamine (MDMA) in Psychiatry: Pros, Cons, and Suggestions.

BACKGROUND: For a number of mental health disorders, including posttraumatic stress disorders (PTSD), there are not many available treatment options. Recently, there has been renewed interest in the potential of methylenedioxymethamphetamine (MDMA) to restore function for patients with these disorders. The primary hypothesis is that MDMA, via prosocial effects, increases the ability of patients to address the underlying psychopathology of the disorder. However, the use of MDMA poses potential problems of neurotoxicity, in addition to its own potential for misuse. METHODS: In this article, the proposed potential of MDMA as an adjunct to psychotherapy for PTSD is evaluated. The rationale for the use of MDMA and the positive results of studies that have administered MDMA in the treatment of PTSD are provided (pros). A description of potential adverse effects of treatment is also presented (cons). An overview of MDMA pharmacology and pharmacokinetics and a description of potential adverse effects of treatments are also presented. Methylenedioxymethamphetamine-produced oxytocin release and decreased expression of fear conditioning as well as one of the MDMA enantiomers (the n R- entaniomer) are suggested as potential mechanisms for the beneficial effects of MDMA in PTSD (suggestions). RESULTS: There is some evidence that MDMA facilitates recovery of PTSD. However, the significant adverse effects of MDMA raise concern for its adoption as a pharmacotherapy. Alternative potential treatments with less adverse effects and that are based on the ubiquitous pharmacology of MDMA are presented. CONCLUSIONS: We suggest that additional research investigating the basis for the putative beneficial effects of MDMA might reveal an effective treatment with fewer adverse effects. Suggestions of alternative treatments based on the behavioral pharmacology and toxicology of MDMA and its enantiomers are presented.

Participant perspectives on the Australian WHO ASSIST Phase III brief intervention for illicit drug use in a primary healthcare setting.

This study explored the experience and self-reported changes in health behaviours of people in a primary healthcare setting who received a brief intervention (BI) for illicit drugs linked to the Alcohol Smoking Substance Involvement Screening Test (ASSIST). Eighty-two participants from a sexual health clinic in Adelaide, South Australia, who were involved in a randomised controlled trial investigating the effectiveness of an ASSIST-linked BI delivered at baseline, were re-interviewed 3 months later and were administered a semi-structured questionnaire designed to elicit participant perspectives on the BI. Overall, participants' comments were positive, with 78% reporting that the BI had some influence on their drug-taking behaviour; 72% reporting they had attempted to reduce drug use. Their comments highlighted several ways in which the BI helped them become 'aware' of the potential risks of using, the risks of continued substance use, the benefits of stopping or cutting down substance use and the strategies they used to change their behaviour. A smaller proportion of participants reported that the BI had no influence. These results indicate the ASSIST-linked BI is a brief, simple-to-administer intervention that provides participants with an opportunity to voluntarily and successfully enter into an intentional process of change.

Alcohol consumption in New Zealand women before and during pregnancy: findings from the Growing Up in New Zealand study.

AIM: To examine alcohol consumption before and during pregnancy in the mothers of a contemporary sample of New Zealand children. METHOD: Analysis of data from the antenatal assessment of 6,822 women enrolled in the Growing Up in New Zealand study, using logistic regression models to examine associations between maternal alcohol use and maternal demographics, pregnancy planning and parity. RESULTS: Seventy-one percent of women drank alcohol before becoming pregnant, 23% during and 13% after the first trimester. The odds of drinking alcohol before pregnancy were significantly higher for younger women who were European or Maori with an unplanned pregnancy and in their first pregnancy; during the first trimester, higher for women who were European or Maori with no secondary school qualification, in their first pregnancy, with an unplanned pregnancy; and in the second and third trimesters, higher for European or Maori women aged 30 and over, in their first pregnancy. CONCLUSIONS: Drinking is common in New Zealand women before pregnancy, particularly among European and Maori women. Some women consume small amounts of alcohol and some engage in heavy drinking in pregnancy. Both are a risk for fetal harm. Population-wide and targeted measures are needed to reduce consumption overall and provide support to specific population groups.

The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial.

BACKGROUND: Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions. METHODS: This is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups. DISCUSSION: People with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates. TRIAL REGISTRATION: Australian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).