Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation, Alcohol Drinking

In brief

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.

Key facts

Study ID

NCT02859142

Run by

University of Chicago

People needed

122

Starts

2018-03-29

Expected to finish

2020-10-15

Last updated by the study team

2021-09-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Addictions Research Laboratory — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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