QuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification.

INTRODUCTION: The QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service. METHODS: QuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an NVP. Treatment adherence and acceptability, self-reported abstinence, cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms were assessed at 6 and 12 weeks. Results are reported for complete cases and for abstinence outcomes, penalized imputation results are reported where missing is assumed smoking. RESULTS: Retention on was 63% at 6 weeks and 50% at 12 weeks. At 12 weeks, 68% of the NRT group reported using combination NRT while 96% of the NVP group used the device. Acceptability ratings for the products were high in both groups. At 12 weeks, 14% of the NVP group and 18% of the NRT group reported not smoking at all in the last 7 days. Mean CPD among continued smokers decreased significantly between baseline to 12 weeks in both groups; from 19.91 to 4.72 for the NVP group (p < .001) and from 20.88 to 5.52 in the NRT group (p < .001). Cravings and withdrawal symptoms significantly decreased for both groups. CONCLUSIONS: Clients completing residential withdrawal readily engaged with smoking cessation post-treatment when given the opportunity. Further research is required to identify the most effective treatments postwithdrawal for this population at elevated risk of tobacco-related harm. TRIAL REGISTRATION NUMBER: ACTRN12617000849392. IMPLICATIONS: This pilot study showed that smoking cessation support involving options for nicotine replacement and Quitline-delivered cognitive behavioral counseling is attractive to people after they have been discharged from SUD treatment. Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked. Some participants self-reported abstinence from cigarettes-around one in five reported having quit smoking cigarettes at 12 weeks postdischarge. The results have significant public health implications for providing quit support following discharge from SUD treatment.

Staying Quit After Release (SQuARe) trial protocol: a randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia.

INTRODUCTION: Smoke-free policies have been introduced in prisons internationally. However, high rates of relapse to smoking after release from prison indicate that these policies typically result in short-term smoking cessation only. These high rates of relapse, combined with a lack of investment in relapse prevention, highlight a missed opportunity to improve the health of a population who smoke tobacco at two to six times the rate of the general population. This paper describes the rationale and design of a randomised controlled trial, testing the effectiveness of a caseworker-delivered intervention promoting smoking cessation among former smokers released from smoke-free prisons in Victoria, Australia. METHODS AND ANALYSIS: The multicomponent, brief intervention consists of behavioural counselling, provision of nicotine spray and referral to Quitline and primary care to promote use of government-subsidised smoking cessation pharmacotherapy. The intervention is embedded in routine service delivery and is administered at three time points: one prerelease and two postrelease from prison. Control group participants will receive usual care. Smoking abstinence will be assessed at 1 and 3 months postrelease, and confirmed with carbon monoxide breath testing. Linkage of participant records to survey and routinely collected administrative data will provide further information on postrelease use of health services and prescribed medication. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Corrections Victoria Research Committee, the Victorian Department of Justice Human Research Ethics Committee, the Department of Human Services External Request Evaluation Committee and the University of Melbourne Human Research Ethics Committee. Results will be submitted to major international health-focused journals. In case of success, findings will assist policymakers to implement urgently needed interventions promoting the maintenance of prison-initiated smoking abstinence after release, to reduce the health disparities experienced by this marginalised population. TRIAL REGISTRATION NUMBER: ACTRN12618000072213; Pre-results.

Systematic Review of Factors Influencing Smoking Following Release From Smoke-Free Prisons.

INTRODUCTION: Given the current proliferation of prison smoke-free policies internationally, and the multiple benefits of continued smoking abstinence for correctional populations, improved understanding of factors influencing postrelease smoking abstinence is required to inform support strategies aimed at individuals exiting smoke-free prisons. METHODS: We systematically searched health, social science, and criminal justice databases for studies relating to smoking behaviors among people released from smoke-free prisons. Studies were included if: they were published between January 1, 2000 and July 26, 2017; they were published in English; the population was people who were incarcerated or formerly incarcerated in prisons with total smoke-free policies; and the reported outcomes included measures of: (1) prerelease intention to smoke or remain abstinent from smoking following release, (2) smoking relapse or abstinence following release, or (3) quit attempts following postrelease smoking relapse. Both authors independently screened returned citations to assess eligibility and reviewed studies for methodological quality using the Effective Public Health Practice Project's Quality Assessment Tool for Quantitative Studies. RESULTS: Fifteen of 121 publications were included. The evidence base in this area is small, almost exclusively US-based, and is mostly methodologically weak. Interventions delivered both pre and postrelease, that strengthen intention to quit, integrate with other substance-use treatment, and facilitate social support for quitting may help maintain postrelease smoking abstinence. CONCLUSIONS: There is an urgent need for high-quality research to inform interventions to reduce high smoking relapse rates upon release from smoke-free prisons, to extend the multiple benefits of continued smoking abstinence into the community. IMPLICATIONS: Interventions designed to help people remain abstinent from tobacco following release from smoke-free prisons are an important opportunity to improve the health, finances, and well-being of this vulnerable population.

Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial.

BACKGROUND: Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more common and rapid compared with the general population of smokers. New ways to address smoking in this population are needed. Electronic nicotine devices (ENDs) or electronic cigarettes hold significant potential as both cessation aids and harm reduction support. This study focuses on the potential of ENDs to facilitate smoking cessation and to sustain it in the medium term among people in treatment for AOD use. The aim of this trial is to explore the effectiveness, feasibility and acceptability of ENDs for smoking cessation compared with combination nicotine replacement therapy (NRT) for clients after discharge from a smoke-free AOD residential withdrawal service. METHODS/DESIGN: The study is a pragmatic randomised controlled trial. In total, 100 participants will be recruited following admission to a smoke-free residential withdrawal service in Melbourne, Australia. Participants will complete a baseline survey and be randomised to either the END group (n = 50) or the NRT group (n = 50) prior to discharge. Both groups will receive telephone counselling support from quitline. Follow-up measures will be assessed at 6 and 12 weeks following discharge. The primary outcome is continuous abstinence from smoking at 12 weeks post discharge. Secondary outcomes include: 7-day point prevalence from smoking, point prevalence abstinence from all nicotine (including NRT and ENDs), cravings and withdrawal, time to relapse, and treatment adherence (use of NRT, ENDs and quitline). DISCUSSION: This is the first randomised controlled trial to assess the effectiveness and acceptability of ENDs within a population dependent on AOD, a priority group with very high levels of smoking. The research will test a model of how to incorporate novel smoking cessation support into a period of high treatment receptiveness. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12617000849392 . Registered on 8 June 2017.

Nicotine Withdrawal, Relapse of Mental Illness, or Medication Side-Effect? Implementing a Monitoring Tool for People With Mental Illness Into Quitline Counseling.

BACKGROUND: Smokers with mental illness and their health care providers are often concerned that smoking cessation will worsen mental health. Smokers with mental illness tend to be more nicotine-dependent and experience more severe symptoms of nicotine withdrawal, some of which are difficult to distinguish from psychiatric symptoms. In addition, smoking cessation can increase the blood levels and hence side effects of some psychotropic medications. Improved monitoring of nicotine withdrawal and medication side effects may help distinguish temporary withdrawal symptoms from psychiatric symptoms and facilitate targeted treatment to help smokers with mental illness manage the acute phase of nicotine withdrawal. OBJECTIVE: The aim of this research was to examine the acceptability and feasibility to quitline counselors of implementing structured assessments of nicotine withdrawal and common medication side effects in people with mental illness who are quitting smoking using a telephone smoking cessation service. METHODS: Monitoring involves administering (once pre-cessation and at each contact post-cessation) (1) the Minnesota Nicotine Withdrawal Scale, assessing eight symptoms: anger, anxiety, depression, cravings, difficulty concentrating, increased appetite, insomnia, and restlessness and (2) an adverse side effects checklist of 5 to 10 symptoms, for example, dry mouth and increased thirst. Following a 1-day update training in mental health, quitline counselors were asked to offer these assessments to callers disclosing mental illness in addition to usual counseling. Group interviews with counselors were conducted 2 months later to examine implementation barriers and benefits. RESULTS: Barriers included awkwardness in integrating a new structured practice into counseling, difficulty in limiting some callers to only the content of new items, and initial anxieties about how to respond to changes in some symptoms. Benefits included the ability to provide objective feedback on changes in symptoms, as this identified early benefits of quitting, provided reassurance for clients, and provided an opportunity for early intervention where symptoms worsened. CONCLUSIONS: Structured monitoring of withdrawal symptoms and medication side effects was able to be integrated into the quitline's counseling and was valued by counselors and clients. Given evidence of its benefits in this limited pilot study, we recommend it be considered for larger-scale adoption by quitlines.

Helping smokers with depression to quit smoking: collaborative care with Quitline.

OBJECTIVES: To report smokers' evaluations and uptake of Quitline-doctor comanagement of smoking cessation and depression, a key component of the Victorian Quitline's tailored call-back service for smokers with a history of depression and to explore its relationship to quitting success. DESIGN, PARTICIPANTS AND SETTING: Prospective study followed Quitline clients disclosing doctor-diagnosed depression (n = 227). Measures were taken at baseline (following initial Quitline call), posttreatment (2 months) and 6 months from recruitment (77% and 70% response rates, respectively). MAIN OUTCOME MEASURES: Uptake of comanagement (initiated by fax-referral to Quitline), making a quit attempt (quit for 24 hours), sustained cessation (> 4 months at 6-month follow-up). RESULTS: At 2-month follow-up, 83% thought it was a good idea to involve their doctor in their quit attempt, 74% had discussed quitting with their doctor, and 43% had received comanagement. In all, 72% made a quit attempt, 37% and 33% were abstinent posttreatment and at 6 months, respectively, and 20% achieved sustained cessation. Among participants who discussed quitting with their doctor, those receiving comanagement were more likely to make a quit attempt than those who did not receive comanagement (78% v 63%). Participants with comanagement also received more Quitline calls (mean 4.6 v 3.1) - a predictor of sustained cessation. Exacerbation of depression between baseline and 6 months was reported by 18% of participants but was not related to cessation outcome. CONCLUSION: Quitline-doctor comanagement of smoking cessation and depression is workable, is valued by smokers, and increases the probability of quit attempts. Smoking cessation did not increase the risk of exacerbation of depression.

The potential of quitlines to increase smoking cessation.

Quitlines are increasingly becoming a core smoking cessation resource. This paper canvasses the potential of quitlines and briefly reviews the evidence for their utility. Quitlines can be an effective means of helping smokers quit. They can provide a triage service helping to direct smokers to the most appropriate assistance, and they can provide cessation help, either one-off sessions or systematic programmes of call-back counselling. Quitlines have features that uniquely place them to provide effective, accessible and affordable cessation help to large numbers and they can be modified readily to meet the needs of groups with special needs, including the capacity to act as part of co-ordinated care with face-to-face services. Quitlines are likely to become an even more important part of tobacco control infrastructure over the next few years.

Can transtheoretical model measures predict relapse from the action stage of change among ex-smokers who quit after calling a quitline?

This study explored whether transtheoretical model (TTM) measures could predict relapse from the action stage, i.e., during the first 6 months of smoking cessation. Predictors of relapse were examined between time 2 (3-month) and time 3 (6-month) assessments (n = 247), and also between time 3 (6-month) and time 4 (12-month) assessments (n = 204). Consistent predictors of relapse included lower self-efficacy and determination to quit and higher temptations to smoke. Some predictors of relapse changed according to how long a person had already been quit for. Contrary to the TTM, greater behavioral change process use predicted relapse among people who had already quit for less than a month, and did not prevent relapse among those who had already quit for a month or more between time 2 and time 3. Cross-sectional analyses showed significant decreases in temptations to smoke and in the use of some of the change processes, which stabilised at about 1 month post-cessation. The findings suggest that there may be a stage boundary at around 1 month post-cessation, and question the homogeneity, and hence validity, of the TTM-defined action stage of change.

What is the right thing at the right time? Interactions between stages and processes of change among smokers who make a quit attempt.

C. A. Perz, C. C. DiClemente, and J. P. Carbonari (1996) claim support for the transtheoretical model notion that success in smoking cessation involves doing the right thing at the right time: emphasising experiential change processes during the contemplation and preparation stages and shifting to behavioral process activities during action. A key methodological limitation of Perz et al. was their failure to control for stage of change, a measure that has been shown to be predictive of cessation. This study replicates the prospective findings of Perz et al. in a different data set, then controls for stage of change when it is predictive of cessation, and finds that the measures of "appropriate" change process use developed by Perz et al. no longer predict cessation. The authors conclude that stage of change, in particular the distinction between smoking and not smoking, is more important than change process use in predicting cessation outcomes.