CompletedPhase 2

Varenicline for Smoking Cessation in Heavy Drinking Smokers

30 participantsStarted 2008-10

Plain-language summary

The purpose of this study is to determine whether extended pretreatment with varenicline (Chantix) is more efficacious for smoking cessation than standard pretreatment, how well varenicline is tolerated in heavy drinking smokers, and whether varenicline reduces alcohol consumption.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Between the ages of 18 and 75.
✓. Smoking 5 or more cigarettes per occasion at least 3 times per week.
✓. Fewer than 3 months of smoking abstinence in the past year.
✓. Motivated to stop smoking.
✓. Report exceeding maximum weekly drinking limits every week in the past 4 weeks and exceeding maximum daily drinking limits on at least 1 occasion in the past 4 weeks. Weekly heavy drinking is defined as 8 or more drinks for women and 15 or more drinks for men. Daily heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on an occasion.

Exclusion criteria

✕. Exhibit current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
✕. Any unexplained elevations in liver enzymes (i.e., transaminases, bilirubin)
✕. Clinically significant cardiovascular disease
✕. Uncontrolled hypertension
✕. Hepatic or renal impairment
✕. Severe chronic obstructive pulmonary disease
✕. Diabetes mellitus requiring insulin or oral hypoglycemic medications.
✕. Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg

What they're measuring

Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.

Timeframe: Last 4 weeks of treatment

Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions

Timeframe: First 3 weeks (pretreatment)

Trial details

NCT IDNCT00860028

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05

Results submitted2012-01-03

View on ClinicalTrials.gov More Nicotine Dependence trials