Inequality in Smoking Cessation Clinical Trials: Excluding Individuals with Mental Health Disorders

Aug.15.2022
Inequality in Smoking Cessation Clinical Trials: Excluding Individuals with Mental Health Disorders
People with mental health disorders are often excluded from smoking cessation clinical trials, highlighting the need for more inclusive research.

Data consistently shows that individuals with mental illness are more likely to smoke than those without, making it crucial to include them in clinical trials related to smoking cessation. Unfortunately, the opposite seems to be true. The commentary, titled "Inequities in smoking cessation clinical trials testing pharmacotherapy: excluding smokers with mental health disorders," aims to examine the practice and reasons behind excluding smokers with mental health disorders from such clinical trials.


A research team has analyzed the Cochrane systematic review database as of September 2020 to obtain evaluations regarding the use of drug therapy for smoking cessation. "We included 279 randomized controlled trials (RCT) from 13 Cochrane reviews. In all studies, 51 (18.3%) explicitly excluded participants with any mental health disorders (MHD), 152 (54.5%) conditionally excluded based on certain MHD criteria, and 76 (27.2%) provided insufficient information to determine inclusion or exclusion. The study found that compared to studies on nicotine replacement therapy, research on using antidepressant medication for smoking cessation was 3.33 times more likely to conditionally exclude smokers with MHD (95% CI 1.38 to 8.01, p=0.007)," the researchers reported.


In fact, their conclusion was that there wasn't enough representation of smokers with MHD in clinical trials examining the safety and efficacy of smoking cessation drugs, but there wasn't enough data collected to explain why. The study emphasized the importance of promoting participation from this minority group in trials.


Psychologically healthy patients find quitting smoking more difficult.


Other studies have also found that individuals with mental health conditions are not only more likely to smoke than those without such conditions, but also have a harder time quitting. As a result, they can greatly benefit from additional support in terms of cessation and access to safer alternatives. This would at least reduce their risk of developing smoking-related illnesses.


However, an article in the Psychiatry Advisor discusses what mental health professionals should keep in mind when using e-cigarettes and warns of dangerous components such as zinc, lead, chromium, manganese, and copper found in various e-cigarette products. Dr. Catherine Striley, Associate Professor and Director of Epidemiology in Psychiatry at the University of Florida, wrote the article and added that while most components in e-liquids can be safely ingested, they may cause harm to the lungs and cardiovascular system.


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