Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Yale University

Status and phase

Completed

Phase 2

Conditions

Alcohol Drinking

Treatments

Drug: varenicline

Drug: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00580645

R01AA015596-01 (U.S. NIH Grant/Contract)

HIC0702002391

Details and patient eligibility

About

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.

Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.

Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.

Enrollment

60 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

21 years old or older
Able to read and write in English
Smokers, non-daily smokers, and non-smokers
Heavy Drinkers and/or meet criteria for alcohol use disorders

Exclusion criteria

Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
Significant hepatocellular injury
Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
Women who are pregnant or nursing
Suicidal, homicidal, or evidence of severe mental illness
Prescription of any psychotropic drug in the 30 days prior to study enrollment
Blood donation within the past 8 weeks
Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months
Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
Known allergy to varenicline or taking H2blockers
Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Subjects likely to exhibit clinically significant alcohol withdrawal during the study