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.

"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.

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.

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.

Outpatient psychosocial substance use treatments for young people: An overview of reviews.

BACKGROUND: Systematic reviews and meta-analyses (reviews) conflict regarding the efficacy and feasibility of substance disorder treatments for young people (YP). This overview of reviews, synthesizes, and methodologically assesses reviews examining substance disorder interventions for YP in outpatient settings. METHODS: Reviews published between 1990 and March 2018 were searched using EBM Reviews, PsycINFO, Embase, Ovid Medline, and Campbell Collaboration. Reviews investigating efficacy and/or feasibility of YP substance disorder treatments in outpatient settings were included. FORTY-THREE REVIEWS MET ALL INCLUSION CRITERIA: To appraise methodological biases, 40 reviews were assessed using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR2) and 3 were narratively assessed. One reviewer (NS) extracted study data and evaluated all 43 reviews. For inter-rater reliability, 13 (30%) reviews were extracted and appraised in duplicate by a second reviewer (JA, RC or ES). Agreement on AMSTAR2 ratings reached 100%. Agreement was moderate; κ = .52 (p < .05), 95% CI (.20, .84). RESULTS: All high quality methodological reviews (n = 6) focused on intervention efficacy and none on treatment feasibility. One (n = 1) high quality review reported evidence for an intervention. Multidimensional Family Therapy (MDFT) has possible efficacy in reducing YP substance use when compared to treatment as usual, Cognitive Behavior Therapy, Adolescent Community Reinforcement Approach and Multifamily Educational Therapy. CONCLUSIONS: Methodological and reporting quality of reviews require improvement. High quality reviews focused on intervention efficacy but treatments commonly lacked evidence. One high quality review found MDFT demonstrated promising outcomes. Reviews examining feasibility of interventions were of low methodological quality.

Cytisine for nicotine addiction treatment: a review of pharmacology, therapeutics and an update of clinical trial evidence for smoking cessation.

AIMS: To review cytisine's history of use, pre-clinical evidence, clinical pharmacokinetics, efficacy, adverse reactions (ARs) and safety for smoking cessation. METHODS: A synoptic review of the use of cytisine as a smoking cessation medication, mechanism of action, pharmacokinetics and safety. Relevant literature on data included in these sections were identified through a search of 11 databases with additional literature obtained from reports and monographs. Three databases (PubMed, EMBASE and www.elibrary.ru) were systematically searched for studies published from 2012 to August 2018 in any language to provide an updated meta-analysis of cytisine's efficacy and ARs for smoking cessation compared with placebo. We pooled the relative risks (RR) of abstinence in the efficacy analysis and RR of ARs, either reported by the authors or calculated from the reports. RESULTS: Cytisine has been in use since 1964 and is currently marketed in 18 countries. Systemic bioavailability from oral ingestion is high and clearance is primarily renal, with minimal or no metabolism. Brain uptake in animal models is moderate. The plasma half-life averages 4.8 hours. Eight studies were included for meta-analysis of efficacy. With heterogeneous results, the overall RR versus placebo of successful continuous abstinence at the longest follow-up was 1.74 [95% confidence interval (CI) = 1.38-2.19]. Nausea, vomiting, dyspepsia, upper abdominal pain and dry mouth that were mild or moderate were the most common ARs, with RR versus placebo 1.10 (95% CI = 0.95-1.28). The cost of cytisine in eastern and central Europe is several-fold less than that of other smoking cessation medications. CONCLUSIONS: Cytisine is a low-cost medication found to increase the likelihood of smoking cessation. The most frequently reported ARs of cytisine involve gastrointestinal symptoms that are mostly reported as either mild or moderate in severity.

A mixed methods randomised control trial to evaluate the effectiveness of the journey to social inclusion - phase 2 intervention for chronically homeless adults: study protocol.

BACKGROUND: Chronic homelessness is a problem characterised by longstanding inability to attain or maintain secure accommodation. Longitudinal research with homeless populations is challenging, and randomised controlled trials that evaluate the effectiveness of intensive, case management interventions aimed at improving housing and health-related outcomes for chronically homelessness people are scant. More research is needed to inform programmatic design and policy frameworks in this area. This study protocol details an evaluation of the Journey to Social Inclusion - Phase 2 program, an intervention designed to reduce homelessness and improve outcomes in chronically homeless adults. METHODS/DESIGN: J2SI Phase 2 is a three-year, mixed methods, multi-site, RCT that enrolled 186 participants aged 25 to 50 years between 07 January 2016 and 30 September 2016 in Melbourne. The intervention group (n = 90 recruited) receives the J2SI Phase 2 program, a trauma-informed intervention that integrates intensive case management and service coordination; transition to housing and support to sustain tenancy; and support to build social connections, obtain employment and foster independence. The comparison group (n = 96 recruited) receives standard service provision. Prior to randomisation, participants completed a baseline survey. Follow-up surveys will be completed every six months for three years (six in total). In addition to self-report data on history of homelessness and housing, physical and mental health, substance use, quality of life, social connectedness and public service utilisation, linked administrative data on participants' public services utilisation (e.g., hospitalisation, justice system) will be obtained for the three-year period pre- and post-randomisation. Semi-structured, qualitative interviews will be conducted with a randomly selected subset of participants and service providers at three time-points to explore changes in key outcome variables and to examine individual experiences with the intervention and standard service provision. An economic evaluation of the intervention and associated costs will also be undertaken. DISCUSSION: Results of this trial will provide robust evidence on the effectiveness of J2SI Phase 2 compared to standard service provision. If the intervention demonstrates effectiveness in improving housing, health, quality-of-life, and other social outcomes, it may be considered for broader national and international dissemination to improve outcomes among chronically homeless adults. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616000162415 (retrospectively registered 10-February-2016).

Factors associated with Quitline and pharmacotherapy utilisation among low-socioeconomic status smokers.

AIMS: To examine factors associated with Quitline and pharmacotherapy utilisation in low socioeconomic status (low-SES) smokers enrolled in a smoking cessation trial. METHODS: Baseline data was used from a large-scale smoking cessation randomised controlled trial (RCT). Logistic regression models were used to examine predictors of treatment utilisation prior to entering the RCT and perceived effectiveness of past and future use. RESULTS: A total of 1047 smokers consented and prior to enrolment 92% had previously tried to quit smoking, 86% had ever used quit support, 83% had used pharmacotherapy at least once and 38% had ever utilised Quitline. For those who had used pharmacotherapies, 71% used NRT, of which 21% had used dual NRT products. In the last 12-months, 27% utilised Quitline and 50% utilised NRT. Ever use of Quitline was negatively associated with self-efficacy to quit (OR: 0.80; 95% CI: 0.68, 0.94 p < .01) and positively associated with being diagnosed with a mental health condition (OR: 1.50; 95% CI: 1.01, 2.25 p < .05). Recent use of NRT was positively associated with mental health condition (OR: 1.39; 95% CI: 1.02, 1.90 p < .05) and negatively associated with alcohol consumption (OR: 0.69; 95% CI: 0.52, 0.92 p < .01). CONCLUSION: Past use of Quitline and pharmacotherapy treatment was associated with self-efficacy to quit, sociodemographic variables, mental health conditions and alcohol consumption. Community-based strategies that target smoking, mental health and drug and alcohol problems may overcome some of the barriers that prevent low-SES populations from engaging with smoking cessation support.

The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial.

BACKGROUND AND AIMS: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant-based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline. DESIGN: Two-arm, parallel group, randomized, non-inferiority trial, with allocation concealment and blinded outcome assessment. SETTING: Australian population-based study. PARTICIPANTS: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services. INTERVENTION AND COMPARATOR: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12-minute sessions). MEASUREMENTS: Assessments will be undertaken by telephone at baseline, 4 and 7 months post-randomization. Participants will also be contacted twice (2 and 4 weeks post-randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview. COMMENTS: If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world-wide.

Brief intervention on Smoking, Nutrition, Alcohol and Physical (SNAP) inactivity for smoking relapse prevention after release from smoke-free prisons: a study protocol for a multicentre, investigator-blinded, randomised controlled trial.

INTRODUCTION: Smoking remains the leading risk factor for disease burden and mortality worldwide. Heavy Smoking is often associated with poor Nutrition, Alcohol abuse and Physical inactivity (known as 'SNAP'). Australia's first prison smoking ban was introduced in the Northern Territory in July 2013. However, relapse to smoking after release from prison is normative. Holistic and cost-effective interventions are needed to maintain post-release abstinence to realise the potential public health impact of smoke-free prison policies. Rigorous, large-scale trials of innovative and scalable interventions are crucial to inform tobacco control policies in correctional settings. METHODS AND ANALYSIS: This multicentre, investigator-blinded, randomised parallel superiority trial will evaluate the effectiveness of a brief intervention on SNAP versus usual care in preventing smoking relapse among people released from smoke-free prisons in the Northern Territory, Australia. A maximum of 824 participants will be enrolled and randomly assigned to either SNAP intervention or usual care at a 1:1 ratio at baseline. The primary endpoint is self-reported continuous smoking abstinence three months after release from prison, verified by breath carbon monoxide test. Secondary endpoints include seven-day point prevalence abstinence, time to first cigarette, number of cigarettes smoked post release, Health Eating Index for Australian Adults, Alcohol Use Disorder Identification Test-Consumption and International Physical Activity Questionnaire scores. The primary endpoint will be analysed on an intention-to-treat basis using a simple log binomial regression model with multiple imputation for missing outcome data. A cost-effectiveness analysis of the brief intervention will be conducted subsequently. ETHICS AND DISSEMINATION: This study was approved by the University of New South Wales Human Research Ethics Committee (HREC), Menzies HREC and Central Australia HREC. Primary results of the trial and each of the secondary endpoints will be submitted for publication in a peer-review journal. TRIAL REGISTRATION NUMBER: ACTRN12617000217303; Pre-results.

The Methodological Quality and Effectiveness of Technology-Based Smoking Cessation Interventions for Disadvantaged Groups: A Systematic Review and Meta-analysis.

Aims: To assess the methodological quality and effectiveness of technology-based smoking cessation interventions in disadvantaged groups. Method: Four databases (EMBASE, Cochrane, Medline, and PsycInfo) were searched for studies conducted from 1980 to May 2016. Randomized controlled trials that compared a behavioral smoking cessation intervention delivered primarily through a technology-based platform (eg, mobile phone) with a no-intervention comparison group among disadvantaged smokers were included. Three reviewers assessed all relevant studies for inclusion, and one reviewer extracted study, participant and intervention-level data, with a subset crosschecked by a second reviewer. Results: Thirteen studies targeting disadvantaged smokers (n =4820) were included. Only one study scored highly in terms of methodological rigor on EPOC criteria for judging risk of bias. Of the 13 studies using a technology-based platform, most utilized websites (n = 5) or computer programs (n = 5), and seven additionally offered nicotine replacement therapy. Technology-based interventions increased the odds of smoking cessation for disadvantaged groups at 1 month (odds ratio [OR] 1.70, 95% confidence interval [CI] 1.10, 2.63), 3 months (OR 1.30, 95% CI 1.07, 1.59), 6 months (OR 1.29, 95% CI 1.03, 1.62), and 18 months post-intervention (OR 1.83, 95% CI 1.11, 3.01). Conclusion: Few methodologically rigorous studies were identified. Mobile phone text-messaging, computer- and website-delivered quit support showed promise at increasing quit rates among Indigenous, psychiatric and inpatient substance use disorder patients. Further research is needed to address the role technology-based interventions have on overcoming health inequalities to meet the needs of disadvantaged groups. Implications: This review provides the first quantitative evidence of the effectiveness of a range of technology-based smoking cessation interventions among disadvantaged smokers, with separate estimates on the basis of intervention type, and cessation outcome measure. Providing cost-effective, easily accessible and real-time smoking cessation treatment is needed, and innovative technology-based platforms will help reach this endpoint. These interventions need to be tested in larger scale randomized controlled trial designs and target broader disadvantaged groups. Data collection beyond 6 months is also needed in order to establish the efficacy of these intervention approaches on long-term cessation rates among disadvantaged population groups.

"I'm not strong enough; I'm not good enough. I can't do this, I'm failing"- A qualitative study of low-socioeconomic status smokers' experiences with accesssing cessation support and the role for alternative technology-based support.

BACKGROUND: The social gradient in smoking rates persist with an overrepresentation of smoking and its associated harms concentrated within lower socioeconomic status (SES) populations. Low-SES smokers are motivated to quit but face multiple barriers when engaging a quit attempt. An understanding of the current treatment service model from the perspectives of treatment-seeking low-SES smokers is needed to inform the design of alternative smoking cessation support services tailored to the needs of low-SES populations. This qualitative study aimed to: i) explore low-SES smokers' recent quitting experiences; ii) assess factors that impact treatment engagement; and iii) determine the acceptability and feasibility of alternative approaches to smoking cessation. METHOD: Low-SES participants (n = 24) previously enrolled in a smoking cessation RCT participated in either a semi-structured focus group or in-depth telephone interview. Data was obtained and analysed using thematic analysis from October 2015 to June 2016. Analysis was deductive from the interview guide and supplemented inductively. RESULTS: Participants expressed feelings of guilt and shame around their smoking behaviour and experienced stigmatisation for their smoking. Guilt, shame, and stigmatisation negatively impacted treatment seeking behaviours with most avoiding current quit services. Costs of pharmacotherapy and treatment adherence were commonly cited barriers to treatment success. Electronic-cigarettes were perceived to be unsafe due to uncertainty on their legal status and regulatory restrictions. Technology-based text-messaging quit support was endorsed as a more favourable alternative compared to existing behavioural treatment services. CONCLUSION: Stigmatisation was commonly endorsed and acted as an impediment to current treatment utilisation. Electronic-cigarettes may present a viable harm reduction alternative, but their likely uptake in socioeconomically disadvantaged groups in Australia is limited by smokers' uncertainty about their regulation and legality. Mobile phone based cessation support may provide an alternative to telephone counselling and overcome the stigmatisation low-SES smokers face while trying to quit.