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Review
. 2023 Jul;32(4):489-496.
doi: 10.1136/tobaccocontrol-2021-056843. Epub 2021 Dec 3.

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

Saki Rubaiya Talukder  1 , Julia M Lappin  2   3 , Veronica Boland  2 , Hayden McRobbie  2 , Ryan James Courtney  2
Affiliations
Review

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

Saki Rubaiya Talukder et al. Tob Control. 2023 Jul.

Abstract

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.

Keywords: addiction; cessation; disparities; human rights; nicotine.

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Conflict of interest statement

Competing interests: HM has received honoraria for speaking at smoking cessation meetings and attending advisory board meetings that have been organised by Pfizer. SRT, JML, VB and RJC have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
The PRISMA flow chart of the process of identification and eligibility of studies. Online supplemental table provides details of the 279 included RCTs. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; RCTs, randomised controlled trials.
Figure 2
Figure 2
Proportions of selected studies with unclear exclusion criteria, criteria explicitly excluding all classes of MHDs and criteria conditionally excluding some classes of MHDs categorised by years of publication. Proportions add up to 100% within each year category. MHDs, mental health disorders.
Figure 3
Figure 3
Exclusion criteria used in studies that conditionally excluded smokers with MHDs. Proportion of studies that conditionally excluded MHDs, % does not add up to 100 as categories are not mutually exclusive. MHDs, mental health disorders; nAChR, nicotinic acetylcholine receptor; NRTs, nicotine replacement therapies.
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