At a glance
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Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation
In Brief
A Phase 4 clinical trial evaluating Chantix, Behavioral Counseling Sessions, and 2 other interventions for Smoking Cessation and Alcohol Drinking. Completed, enrolled 122 participants across 1 site.
Detailed Summary
The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.
Study Details
Timeline
Interventions
Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions \[0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day\]
One-to-one behavioral counseling sessions with a trained therapist
Nicotine patches provided over 12 week participation
Identical in appearance to varenicline \[0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day\]