At a glance
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Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
In Brief
A Phase 2 clinical trial evaluating Very low nicotine content cigarettes for Tobacco Use Disorder. Completed, enrolled 775 participants across 2 sites.
Detailed Summary
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including site-specific cancers, heart disease, and premature death. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like those with affective disorders who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.