Tailored text-messaging versus standard Quitline telephone counselling for smoking cessation among people who smoke from a low-socio-economic status background in Australia: A study protocol for a non-inferiority randomized controlled trial (The Quit By Phone Study).

BACKGROUND AND AIMS: Signficant inequalities in tobacco smoking exist, with higher smoking rates among people from low-socio-economic status (low-SES) populations. Tailored technology-based programs for low-SES smoking populations have the potential for high reach, but require effectiveness data from large-scale trials. This trial among Australians who smoke from a low-SES background will determine the effectiveness and cost-effectiveness of tailored text-message (TTM) support compared with standard Quitline (SQL) telephone support service. DESIGN, SETTING AND PARTICIPANTS: This is a two-arm, parallel group, randomized, non-inferiority trial with allocation concealment and blinded outcome assessment in an Australian population within the greater Sydney region in New South Wales. Participants are adults who smoke daily (n = 1246), are interested in quitting and currently receiving a government pension or allowance, and will be recruited via advertisements. INTERVENTION AND COMPARATOR: Participants will be randomized (1:1 ratio) to receive either 12 months of TTM quit support or enrolment in SQL telephone support. MEASUREMENTS: Assessments will be completed at baseline (telephone interview), within 1 month (check-in call), at 3 months (on-line questionnaire) and 12 months (telephone interview) post-randomization. The primary outcome will be 6-month continuous abstinence verified by carbon monoxide breath test at 12-month follow-up. The study will test whether TTM is non-inferior to SQL by a non-inferiority margin of 2%, i.e. the quit rate in the TTM group will be no worse than 2% less than the quit rate in the SQL group. Secondary outcomes will include self-reported continuous and point prevalence abstinence and acceptability and cost-effectiveness of TTM versus SQL. CONCLUSION: Should the tailored text-message support prove non-inferior and more cost-effective than Quitline for this population, this will provide an opportunity for the upscaling of an effective, inexpensive and tailored quit support service. The trial findings will inform cessation treatment policy for priority populations in Australia and globally.

Receipt of the 5As intervention for smoking cessation among people with and without mental health disorders.

Brief interventions for smoking cessation, such as the 5As (ask, assess, advise, assist, arrange) are effective, but limited data are available regarding their delivery to smokers with mental health disorders (MHDs), and whether a disparity in care exists. This study explored the difference in the self-reported receipt of 5As between smokers with and without MHDs in a community setting. Baseline data from 1452 (1206 without and 246 with self-reported MHDs) Australian smokers who participated in a smoking cessation trial were analysed. Participants reported interactions with healthcare providers and receipt of the 5As over the past 12 months. Multivariate logistic regression analysis was employed to investigate the association between receipt of the 5As and MHD status. Smokers with MHDs were significantly more likely to be asked, assessed, advised, and assisted compared to those without MHDs, but arranging follow-up was very low in both groups (7.7% with MHDs and 4.1% without MHDs). This is particularly concerning for vulnerable population like smokers with MHDs, who may struggle more in their quit attempt. The findings highlight the need to enhance the implementation of the 'arrange follow-up' component to improve cessation outcomes and reduce health disparities.

Mental health related adverse events of cytisine and varenicline in smokers with and without mental health disorders: Secondary analysis of a randomized controlled trial.

INTRODUCTION: Little is known about the adverse events (AEs) of cytisine versus varenicline among individuals with mental health disorders (MHDs), highlighting the necessity for further exploration to inform clinical practice. This secondary analysis of clinical trial data aimed to investigate the effect of varenicline vs. cytisine regarding mental-health-related AEs (MH-related AEs) on smokers with and without MHDs. METHODS: Australian daily smokers interested in quitting were randomised to varenicline (84 days) or cytisine (25 days) and categorised by self-reported MHD diagnosis or treatment in the past year (MHD or non-MHD groups). Treatment adherence was assessed by self-reported number of doses taken during the active treatment phase via two check-in calls (at one month), while AEs were evaluated through four phone interviews: two check-in calls (one month) and follow-up calls at four and seven months. Logistic regression analysis compared MH-related AEs between groups, including only participants taking at least one dose. RESULTS: Of 1452 smokers 246 reported MHDs, 725 received cytisine and 727 received varenicline. Median number of doses taken was comparable between MHD (34 cytisine and 12 varenicline) and non-MHD (33 cytisine and 13 varenicline) groups. MH-related AEs were: 14.1 % (n = 30) in MHD (12.5 % in cytisine and 15.4 % in varenicline), and 11.8 % (n = 126) in non-MHD group (10.9 % in cytisine and 13.7 % in varenicline). No significant difference in MH-related AE occurrence was identified between medication groups (aOR=0.96, 95 % CI 0.4 to 2.2, p-value = 0.94). CONCLUSION: Comparable MH-related AEs were observed between smokers with and without MHDs, suggesting that cytisine, like varenicline, may be well-tolerated by those with MHDs. However, larger clinical trials focused on MH-related AEs are needed for more conclusive evidence.

Tailoring CONSORT-SPI to improve the reporting of smoking cessation intervention trials: An expert consensus study.

BACKGROUND AND AIMS: Inadequate reporting of smoking cessation intervention trials is common and leads to significant challenges for researchers. The aim of this study was to tailor CONSORT (Consolidated Standards of Reporting Trials)-SPI (Social and Psychological Interventions) guidelines to improve reporting of trials of behavioural interventions to promote smoking cessation. METHOD: Informed by missing data from the IC-SMOKE (Intervention and Comparison group support provided in SMOKing cEssation) systematic review project, this study used a multi-stage Delphi process to examine which items could be added or modified to improve the reporting of smoking cessation trials. The first stage involved an on-line survey of 17 international experts in smoking cessation and trial methodology voting on the importance of items for inclusion in the updated guidelines. This was followed by a face-to-face expert consensus meeting attended by 15 of these experts, where the final inclusion and exclusion of new items and modifications were agreed upon. A nine-point Likert scale was used to establish consensus, with suggested modifications requiring agreement of 75% or more. Disagreements in the first stage were presented again at the second stage for discussion and a second round of voting. Only items which reached the threshold for agreement were included. RESULTS: The experts agreed on the inclusion of 10 new items and the specification of 12 existing items. This included modifications that could apply to trials more widely (e.g. the rationale for the comparator), but also modifications that were very specific to smoking cessation trials (e.g. the reporting of smoking cessation outcomes). CONCLUSIONS: A Delphi study has developed a modified CONSORT-SPI guideline (CONSORT-SPI-SMOKE) to improve the reporting of trials of behavioural interventions to promote smoking cessation.

Development and Validation of LC-MS/MS Method for Determination of Cytisine in Human Serum and Saliva.

Cytisine (CYT) is a quinolizidine alkaloid used for nicotine addiction treatment. Recent clinical trial data regarding cytisine confirm its high effectiveness and safety as a smoking cessation treatment. CYT's popularity is growing due to its increased availability and licensing in more countries worldwide. This increased use by smokers has also resulted in an urgent need for continued drug research, including developing appropriate analytical methods for analyzing the drug in biological samples. In this study, a simple, fast, and reliable method combining hydrophilic interaction liquid chromatography and electrospray ionization quadrupole time of flight mass spectrometry (HILIC/ESI-QTOF-MS) for the determination of CYT in human serum and saliva was developed and validated. This was undertaken after the previous pre-treatment of the sample using solid-phase extraction (SPE). A hydrophilic interaction liquid chromatography (HILIC) column with a silica stationary phase was used for chromatographic analysis. In a linear gradient, the mobile phase consisted of acetonitrile (ACN) and formate buffer at pH 4.0. The proposed method was fully validated and demonstrated its sensitivity, selectivity, precision, and accuracy. The method was successfully applied to determine CYT in serum and, for the first time, in saliva. The findings indicate that saliva could be a promising non-invasive alternative to measure the free concentration of CYT.

Utilising the Implementation of Integrated Care to Develop a Pragmatic Framework for the Sustained Uptake of Service Innovations (SUSI).

The provision of integrated care (IC) across alcohol and other drug (AOD) and mental health (MH) services represents the best practice, yet the consistent delivery of IC in routine practice rarely occurs. Our hypothesis is that there is no practical or feasible systems-change approach to guide staff, researchers, or consumers through the complex transition that is required for the sustained uptake of IC across diverse clinical settings. To address this gap, we combined clinical and consumer expertise with the best available research evidence to develop a framework to drive the uptake of IC. The goal was to develop a process that is both standardised by the best available evidence and can be tailored to the specific characteristics of different health services. The result is the framework for Sustained Uptake of Service Innovation (SUSI), which comprises six core components that are applied in a specified sequence and a range of flexible activities that staff can use to deliver the core components according to their circumstances and preferences. The SUSI is evidence-based and practical, and further testing is currently underway to ensure it is feasible to implement in different AOD and MH services.

"I didn't even know headspace had the drug thing until today": A socio-ecological analysis of access to drug and alcohol interventions in integrated youth health care services.

BACKGROUND: With 150 centers Australia-wide, the headspace National Youth Mental Health Foundation is an exemplary integrated youth health service. Headspace centers provide medical care, mental health interventions, alcohol and other drug (AOD) services, and vocational support to Australian young people (YP) aged 12 to 25 years. Co-located headspace salaried youth workers, private health care practitioners (e.g. psychologists, psychiatrists, and medical practitioners) and in-kind community service providers (e.g. AOD clinicians) form coordinated multidisciplinary teams. This article aims to identify the factors influencing the access to AOD interventions for YP, in the Australian rural headspace setting; as perceived by YP, their family and friends, and headspace staff. METHODS: The study purposively recruited YP (n = 16), their family and friends (n = 9), and headspace staff (n = 23) and management (n = 7) in four headspace centers in rural New South Wales, Australia. Recruited individuals participated in semistructured focus groups about the access to YP AOD interventions in the headspace setting. The study team thematically analyzed the data through the lens of the socio-ecological model. RESULTS: The study identified convergent themes across groups and found several barriers to the access of AOD interventions; 1) YP's personal factors, 2) YP's family and peer attitudes, 3) practitioner skills, 4) organizational processes and 5) societal attitudes were all identified as negatively impacting access to YP AOD interventions. Practitioners' client-centered stance, and the youth-centric headspace model were factors that were considered as enablers of engagement of YP with an AOD concern. INTERPRETATION: While this Australian example of an integrated youth health care model is well placed to provide YP AOD interventions, a mismatch existed between practitioner capability and YP needs. The sampled practitioners described limited AOD knowledge, and low confidence in providing AOD interventions. At the organizational level, multiple AOD intervention supply and utilization issues occurred. Taken together, these problems likely underlie previous findings of poor service utilization and low user satisfaction. CONCLUSION: Clear enablers exist for AOD interventions to be better integrated into headspace services. Future work should determine how this integration can be achieved and what early intervention means in relation to AOD interventions.

A systematic review of factors associated with sustained smoking abstinence in people experiencing severe mental illness following participation in a smoking intervention.

OBJECTIVE: People experiencing severe mental illness report higher rates of tobacco smoking than the general population, while rates of quitting and sustaining abstinence are considerably lower. This systematic review aimed to identify factors associated with sustained abstinence in people experiencing severe mental illness following a smoking intervention. METHOD: Searches were conducted in PubMed, PsycInfo, Scopus, Embase, Emcare, CINAHL and Cochrane Library from the inception of the e-databases until June 2022. Selection criteria included randomised and non-randomised studies of smoking cessation interventions in which most of the participants were experiencing severe mental illness, and reported a follow-up of 3 months or longer. From an initial 1498 unique retrieved records, 26 references were included detailing 17 smoking cessation intervention studies and 3 relapse prevention intervention studies. Risk of bias was assessed using the RoB2 tool for randomised study designs and the ROBINS-I tool for non-randomised designs. RESULTS: Participation in smoking interventions was associated with higher odds of abstinence in the medium-term, but not long-term follow-ups. There was insufficient evidence that any other factors impact sustained abstinence. Most studies were considered to have some risk of bias, largely due to insufficient availability of analysis plans. CONCLUSION: Despite an abundance of studies investigating smoking cessation in smokers experiencing severe mental illness, there is limited knowledge on the factors associated with staying quit. The inclusion of people experiencing severe mental illness in large-scale randomised control trials, in which predictors of sustained abstinence are measured in the medium and long term are needed to address this important question.

The Australasian Professional Society on Alcohol and other Drugs' submission to the consultation draft National Tobacco Strategy 2022-2030.

Tobacco use continues to be a leading cause of death and morbidity globally. At the core of Australia's response to tobacco-related harms is the National Tobacco Strategy which highlights a national collaborative framework to reduce prevalence, and associated health, social and economic impacts of tobacco use. A draft National Tobacco Strategy (2022-2030) has recently been released for consultation and as members of the Australasian Professional Society on Alcohol and other Drugs' Special Interest Group for Smoking Cessation Professionals we provide a commentary on key successes of the previous National Tobacco Strategy, and suggestions for improvement areas to strengthen Australia's policy response to tobacco and e-cigarette-related issues.

Inequity in smoking cessation clinical trials testing pharmacotherapies: exclusion of smokers with mental health disorders.

OBJECTIVES: People suffering from mental health disorder (MHDs) are often under-represented in clinical research though the reasons for their exclusion are rarely recorded. As they have higher rates of smoking and nicotine dependence, it is crucial that they are adequately represented in clinical trials of established pharmacotherapy interventions for smoking cessation. This review aims to examine the practice of excluding smokers with MHDs and reasons for such exclusion in clinical trials evaluating pharmacotherapy treatments for smoking cessation. DATA SOURCE: The Cochrane database of systematic reviews was searched until September 2020 for reviews on smoking cessation using pharmacotherapies. STUDY SELECTION: Randomised controlled trials (RCTs) within the selected Cochrane reviews were included. DATA EXTRACTION: Conducted by one author and independently verified by three authors. DATA SYNTHESIS: We included 279 RCTs from 13 Cochrane reviews. Of all studies, 51 (18.3%) explicitly excluded participants with any MHDs, 152 (54.5%) conditionally excluded based on certain MHD criteria and 76 (27.2%) provided insufficient information to ascertain either inclusion or exclusion. Studies of antidepressant medications used for smoking cessation were found to be 3.33 times more likely (95% CI 1.38 to 8.01, p=0.007) to conditionally exclude smokers with MHDs than explicitly exclude compared with studies of nicotine replacement therapy. CONCLUSION: Smokers with MHDs are not sufficiently represented in RCTs examining the safety and effectiveness of smoking cessation medications. Greater access to clinical trial participation needs to be facilitated for this group to better address access to appropriate pharmacotherapeutic interventions in this vulnerable population.

Household Composition and Smoking Behavior in a Prospective Longitudinal Australian Cohort.

INTRODUCTION: This study estimates the extent to which individuals' smoking cessation and relapse patterns are associated with the smoking behavior of their household members. AIMS AND METHODS: Longitudinal data on household members' smoking behavior was sourced from a representative sample of 12 723 Australians who ever reported smoking between 2001 and 2019. Controlling for a rich set of confounders, multivariate regression analyses were used to predict the likelihood of smoking cessation and relapse given other household members' smoking status and their relationship type. The models were then used to forecast smoking prevalence over 10 years across different household types. RESULTS: Individuals living with a smoking spouse were less likely to quit (OR 0.77 [95% CI 0.72;0.83]) and more likely to relapse (OR 1.47 [95% CI 1.28;1.69]) compared to those living with nonsmoking spouses. Subsequently, the proportion of smokers living with other smoking household members increased by 15% between 2011 and 2019. A 10-year forecast using the smoking cessation and relapse models predicts that, on average, smokers living with nonsmokers will reduce by 43%, while those living alone or with a smoking partner will only reduce by 26% and 28% respectively. CONCLUSIONS: Over time, those who are still smoking are more likely to live with other smokers. Therefore, the current cohort of smokers is increasingly less likely to quit and more likely to relapse. Smoking projection models that fail to account for this dynamic risk may overstate the downstream health benefits and health cost savings. Interventions that encourage smoking cessation at the household level, particularly for spouses, may assist individuals to quit and abstain from smoking. IMPLICATIONS: The current and future paradigm shift in the smoking environment suggests that smoking cessation and relapse prevention policies should consider household structure. Policies designed to affect smoking at the household level are likely to be particularly effective. When estimating the long-term benefits of current smoking policies intrahousehold smoking behavior needs to be considered.

Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial.

BACKGROUND: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]-gum or lozenge) for smoking cessation. METHODS: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. DISCUSSION: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021.  https://www.anzctr.org.au.

Predictors of length of treatment, discharge reason, and re-admission to Aboriginal alcohol and other drug residential rehabilitation services in New South Wales, Australia.

INTRODUCTION: Aboriginal clients accessing Aboriginal community-controlled residential alcohol and other drug rehabilitation services in New South Wales, Australia believe they have better outcomes due to culturally appropriate care. However, there is a paucity of published treatment outcome data. This study aims to identify predictors of treatment outcomes based on client characteristics at intake. METHODS: A cross-sectional, retrospective, observational study of 2326 admissions to six services between January 2011 and December 2016. The outcomes were: (i) leaving treatment early; (ii) self-discharge or house discharge (by staff); and (iii) re-admission within two years. The predictors examined were Aboriginal status, age, justice system referral and primary substance of concern. Competing risk and Poisson regression analyses were used to identify trends in the data. RESULTS: The mean age of clients was 33 years, and the majority (56%) stayed at least 6 weeks. Aboriginal clients whose primary substance of concern was stimulants were almost eight times more likely to re-admitted within 2 years than other clients (risk ratio 7.91; P < 0.001). Aboriginal clients who were also referred from justice were more likely to self-discharge (risk ratio 1.87; P < 0.001). Furthermore, Aboriginal clients who were aged older than 30 were less likely to have a re-admission (risk ratio 0.32; P ≤ 0.001). DISCUSSION AND CONCLUSIONS: This study showed client characteristics that are predictive of harmful outcomes include age under 30, justice client, primary substance of use and their interactions. Future research could build on these results to aid ongoing development of residential rehabilitation programs for Aboriginal peoples.

Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.

Cigarette smoking and e-cigarette use among university students in Queensland, Australia and New Zealand: results of two cross-sectional surveys.

OBJECTIVES: Examine the patterns of cigarette smoking and e-cigarette use (vaping), the perceived harm of e-cigarettes compared with tobacco cigarettes, and associations between smoking and vaping with student characteristics. DESIGN: Cross-sectional studies. SETTING: The University of Queensland (UQ), Australia and eight New Zealand (NZ) universities. PARTICIPANTS: Students at UQ: 4957 (70.8% aged <25 years, 63.0% women) and NZ: 1854 (82.5% aged <25 years, 60.1% women). METHODS: Χ2 tests compared smoking by age and gender, and vaping by age, gender and smoking status. Two-sided p<0.05 was considered significant and 95% CIs reported where appropriate. Multinomial logistic regression examined associations between smoking and vaping (exclusive smoking, exclusive vaping, dual use and non-use) with age, gender and student type (domestic vs international). RESULTS: Smoking (UQ vs NZ, 95% CI): ever 45.2% (43.8% to 46.6%) vs 50.0% (47.7% to 52.3%), current 8.9% (8.1% to 9.7%) vs 10.4% (9.1% to 11.9%) and daily 5.2% (4.6% to 5.8%) vs 5.6% (4.6% to 6.7%), and not smoking in indoor 98.3% vs 87.7% or outdoor smoke-free spaces 83.8% vs 65.3%.Vaping (UQ vs NZ, 95% CI): ever 20.9% (19.8% to 22.1%) vs 37.6% (35.4% to 39.9%), current 1.8% (1.5% to 2.2%) vs 6.5% (5.4% to 7.7%) and daily 0.7% (0.5% to 1.0%) vs 2.5% (1.9% to 3.4%), and not vaping in indoor 91.4% vs 79.6% or outdoor smoke-free spaces 84.4% vs 71.3%. Of respondents, 71.7% (70.3% to 73.2%) vs 75.3% (72.9% to 77.6%) perceived e-cigarettes as less harmful than tobacco cigarettes.Men were more likely than women to smoke and vape, and to believe that e-cigarettes are less harmful. Regression models containing all predictors for smoking and vaping were significant and the effect of gender was significant for dual use, exclusive smoking and exclusive vaping (all p<0.01). Men had higher odds for smoking, vaping or dual use. CONCLUSIONS: Results suggest significant differences in patterns of smoking and vaping of university students in Australia and NZ, and a strong influence of gender on smoking and vaping.

A randomised controlled trial of motivational interview for relapse prevention after release from smoke-free prisons in Australia.

PURPOSE: This paper aims to determine whether a single session of a motivational interview (MI) reduces smoking relapse amongst people released from smoke-free prisons. DESIGN/METHODOLOGY/APPROACH: This study sought to recruit 824 ex-smokers from 2 smoke-free prisons in the Northern Territory, Australia. Participants were randomised to receive either one session (45-60 min) face-to-face MI intervention 4-6 weeks prior to release or usual care (UC) without smoking advice. The primary outcome was continuous smoking abstinence verified by exhaled carbon monoxide test (<5 ppm) at three months post-release. Secondary outcomes included seven-day point-prevalence, time to the first cigarette and the daily number of cigarettes smoked after release. FINDINGS: From April 2017 to March 2018, a total of 557 participants were randomised to receive the MI (n = 266) or UC (n = 291), with 75% and 77% being followed up, respectively. There was no significant between-group difference in continuous abstinence (MI 8.6% vs UC 7.4%, risk ratio = 1.16, 95%CI 0.67∼2.03). Of all participants, 66.9% relapsed on the day of release and 90.2% relapsed within three months. On average, participants in the MI group smoked one less cigarette daily than those in the UC within the three months after release (p < 0.01). RESEARCH LIMITATIONS/IMPLICATIONS: A single-session of MI is insufficient to reduce relapse after release from a smoke-free prison. However, prison release remains an appealing time window to build on the public health benefit of smoke-free prisons. Further research is needed to develop both pre- and post-release interventions that provide continuity of care for relapse prevention. ORIGINALITY/VALUE: This study is the first Australian randomised controlled trial to evaluate a pre-release MI intervention on smoking relapse prevention amongst people released from smoke-free prisons.

Nicotine replacement treatment, e-cigarettes and an online behavioural intervention to reduce relapse in recent ex-smokers: a multinational four-arm RCT.

BACKGROUND: Relapse remains an unresolved issue in smoking cessation. Extended stop smoking medication use can help, but uptake is low and several behavioural relapse prevention interventions have been found to be ineffective. However, opportunistic 'emergency' use of fast-acting nicotine replacement treatment or electronic cigarettes may be more attractive and effective, and an online behavioural Structured Planning and Prompting Protocol has shown promise. The present trial aimed to evaluate the clinical effectiveness and cost-effectiveness of these two interventions. DESIGN: A randomised controlled trial. SETTING: English stop smoking services and Australian quitlines, Australian social media and St Vincent's Hospital Melbourne, Fitzroy, VIC. PARTICIPANTS: Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date. The planned sample size was 1400, but the trial was curtailed when 235 participants were recruited. INTERVENTIONS: Participants were randomised in permuted blocks of random sizes to (1) oral nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages (n = 60), (2) the Structured Planning and Prompting Protocol and interactive text messages (n = 57), (3) oral nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages (n = 58) or (4) usual care plus static text messages (n = 59). OUTCOME MEASURES: Owing to delays in study set-up and recruitment issues, the study was curtailed and the primary outcome was revised. The original objective was to determine whether or not the two interventions, together or separately, reduced relapse rates at 12 months compared with usual care. The revised primary objective was to determine whether or not number of interventions received (i.e. none, one or two) affects relapse rate at 6 months (not biochemically validated because of study curtailment). Relapse was defined as smoking on at least 7 consecutive days, or any smoking in the last month at final follow-up for both the original and curtailed outcomes. Participants with missing outcome data were included as smokers. Secondary outcomes included sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used. Two substudies assessed reactions to interventions quantitatively and qualitatively. The trial statistician remained blinded until analysis was complete. RESULTS: The 6-month relapse rates were 60.0%, 43.5% and 49.2% in the usual-care arm, one-intervention arm and the two-intervention arm, respectively (p = 0.11). Sustained abstinence rates were 41.7%, 54.8% and 50.9%, respectively (p = 0.17). Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57). Of participants allocated to nicotine products, 23.1% were using them daily at 6 months. The online intervention received positive ratings from 63% of participants at 6 months, but the majority of participants (72%) completed one assessment only. Coping strategies taught in the Structured Planning and Prompting Protocol were used with similar frequency in all study arms, suggesting that these are strategies people had already acquired. Only one participant used the interactive texting, and interactive and static messages received virtually identical ratings. LIMITATIONS: The inability to recruit sufficient participants resulted in a lack of power to detect clinically relevant differences. Self-reported abstinence was not biochemically validated in the curtailed trial, and the ecological momentary assessment substudy was perceived by some as an intervention. CONCLUSIONS: Recruiting recent ex-smokers into an interventional study proved problematic. Both interventions were well received and safe. Combining the interventions did not surpass the effects of each intervention alone. There was a trend in favour of single interventions reducing relapse, but it did not reach significance and there are reasons to interpret the trend with caution. FUTURE WORK: Further studies of both interventions are warranted, using simpler study designs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11111428. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 68. See the NIHR Journals Library website for further project information. Funding was also provided by the National Health and Medical Research Council, Canberra, ACT, Australia (NHMRC APP1095880). Public Health England provided the funds to purchase the nicotine products in England.

Stop smoking services help people to stop smoking over a short period of time. However, nearly three-quarters of quitters return to smoking (i.e. relapse) within 1 year. Effective relapse prevention strategies are needed. Traditional behavioural relapse prevention strategies (e.g. teaching techniques to resist having a cigarette) have not proved effective. However, an earlier study showed that an online programme guiding smokers in stopping smoking and remaining abstinent reduced relapse between 1 week and 6 months. Long-term use of stop smoking medications (e.g. nicotine replacement treatment) can also help, but most successful quitters do not continue to use them. Nicotine mouth spray, lozenges or electronic cigarettes that can quickly help relieve urges to smoke and that ex-smokers can use 'in emergencies' could be a more attractive option. We planned to test these two interventions, on their own and together, in 1400 participants who had quit ≥ 4 weeks previously and who were recruited from English stop smoking services and Australian quitlines. We would then compare these participants with the participants following usual care (i.e. access to stop smoking medications used during the quit attempt for up to 3 months). Owing to delays in study set-up and difficulties in recruiting, the study recruited only 234 participants (n = 131 in Australia and n = 103 in England). We studied participants' reactions to the two interventions and to their combination, and how clinically effective the interventions were. Both interventions were rated positively by most participants. Among the participants in Australia, electronic cigarettes were more popular than medical nicotine products. In England, both products were equally popular. Participants in the online intervention group appreciated the advice on coping strategies, but they rarely completed repeat assessments. In addition, participants who were not in this group used the strategies just as much. There were hints that the interventions may be helpful in preventing relapse. There is an indication that the two interventions combined did not do any better than each on its own, but this requires replication in a larger study. Although the interventions show promise, the small number of participants recruited means that we are unable to make strong conclusions. The study identified areas for future work.

Understanding the client characteristics of Aboriginal residential alcohol and other drug rehabilitation services in New South Wales, Australia.

BACKGROUND: Aboriginal alcohol and other drug residential rehabilitation (residential rehabilitation) services have been providing treatment in Australia of over 50 years. However, there are no studies in Australia or internationally that document characteristics of clients attending Indigenous residential rehabilitation services worldwide. This is the first multi-site paper to describe key client characteristics of six Indigenous (hereafter Aboriginal Australians as the term recommended by the Aboriginal Health and Medical Research Council of New South Wales) residential rehabilitation services in Australia. METHODS: All recorded client admissions between 1 January 2011 to 31 December 2016 were considered from six operating services in the Australian state of New South Wales. Data collected were classified into categories based on demographics, treatment utilisation, substance use, mental health and quality of life characteristics. Means, median and percentages were calculated (where appropriate). RESULTS: There were 2645 admissions across the six services in the study period, with an average of 440 admissions per year across all services. Participants were aged between 26 to 35 years, with fewest participants aged 46 +. Program length ranged from 12 to 52 weeks (mean of 12 weeks). The completion rates and length of stay for each service ranged from less than two to more than 12 weeks. The principal drug of choice was alcohol and amphetamines in half of the services. Not all services used them, but a range of tools were used to measure treatment, substance use and mental health or quality of life outcomes. CONCLUSION: This study is the first internationally to describe the key features of multiple Aboriginal residential rehabilitation services. The variation in tools used to collect client data made it difficult to compare client characteristics across services. Future research could explore predictors of treatment completion, identify opportunities for standardisation in client assessments and validate cultural approaches of care. These efforts would need to be guided by Aboriginal leadership in each service.