Overview

This trial is active, not recruiting.

Condition alcohol drinking
Treatments varenicline, bupropion, placebo
Phase phase 2
Sponsor Yale University
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date April 2007
End date December 2017
Trial size 308 participants
Trial identifier NCT00580645, HIC0702002391, R01AA015596-01

Summary

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking.

Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior and a cue reactivity session assessing their reactivity to alcohol-related cues. Subjects are maintained on study medication for 4 weeks after the laboratory session.

The study is subdivided into three studies based on subject population.

Study 1A enrolls heavy drinking smokers (tested under nicotine deprivation). Study 1B enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Study 1C enrolls smokers (not tested under nicotine deprivation) and nonsmokers who meet criteria for alcohol use disorders.

In Study 1A, volunteers are administered either varenicline (Chantix), bupropion (Zyban), or placebo. In Studies 1B and 1C, volunteers are administered either varenicline (Chantix) or placebo.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Studies 1A and 1B: varenicline 2mg/day Study 1C: varenicline 1mg/day or 2mg/day
varenicline Chantix
Studies 1A and 1B: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered twice daily during laboratory session (day 8) and for 4 weeks after laboratory session. Study 1C: 2mg/day (see above) or 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.
(Experimental)
Study 1A only: Bupropion 300mg/day
bupropion Zyban
Study 1A only: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8) and for 4 weeks after laboratory session.
(Placebo Comparator)
Placebo Controlled
placebo
placebo

Primary Outcomes

Measure
number of drinks consumed
time frame: throughout the laboratory session

Secondary Outcomes

Measure
tobacco and alcohol craving
time frame: during laboratory session
tobacco and alcohol craving
time frame: during the cue reactivity session

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.