Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

• Status: Completed
• Trial end date: 2020-10-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Collaborator: Pfizer
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Smoke 3-30 cigarettes/day

• Desire to quit smoking as indicated on a smoking stages ladder

• Consume >14 (men) or >7 (women) standard alcohol drinks per week (e.g., 1 drink = 12 oz beer, 5 oz wine, 1.5 oz liquor)

• Ability to understand, read, and write in English, at least 8th grade education

• Willing and able to sign an informed consent

• Stable residence and contact information.

Exclusion Criteria:

• Hepatic panel indices > 2 SD

• History of seizures or DTs during alcohol withdrawal

• Unstable medical (e.g., hepatitis, cirrhosis, seizure disorder, recent major cardiovascular event, etc.) or psychiatric disorder (e.g., active hallucinations, severe depression, obsessional thinking, self-injury risking significant blood loss, etc.) deemed by the study physician to be at significant risk for adverse interactions with study medications or measures.

• History of adverse reactions to varenicline (VAR) or nicotine patch

• Current suicidal ideation (past 6 months) and/or history of major suicide attempts.

• For women of child-bearing potential: currently pregnant, lactating, current plans to become pregnant in next three months, or unable to agree to adequate birth control during study participation.