drugset / Trial / NCT01928758

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders

NCT01928758

RandomizedParallel-groupDouble-blindHealth-services research

Summary

The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain either a) nicotine content similar to their preferred usual brand of cigarettes, or b) nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine content in the Reduced Nicotine Content group without significant increases in tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the Reduced Nicotine Content group as compared with the control group.

Timeline

Start
2015-09
Primary completion
2018-01-11
Completion
2018-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 0.2 mg
Subject Nicotine Unknown 11.6 mg

Indications