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.

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.