Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Phase 2

Completed

• Conditions: Alcohol Drinking
• Interventions: Drug: varenicline; Drug: placebo

• Registration Number: NCT00580645
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-25
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2017-11-20
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Results First Posted: 2018-02-07
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
varenicline	varenicline	varenicline 1mg/day or 2mg/day
Placebo	placebo	Placebo Controlled

Primary Outcome Measures

Name	Time	Method
Number of Drinks Consumed	2 hour ad-lib drinking period, during the laboratory session (Day 8)	number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session

Secondary Outcome Measures

Name	Time	Method
Alcohol Craving	during laboratory session (Day 8) at baseline	alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)

Trial Locations

Locations (1)

Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory; 🇺🇸 New Haven, Connecticut, United States