Do Treatments for Smoking Cessation Affect Alcohol Drinking?

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Bupropion; Ethanol; Varenicline

Criteria

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