Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
Information source: Yale University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Drinking
Intervention: varenicline (Drug); bupropion (Drug); placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Yale University
Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University
The purpose of this study is to examine the effect of smoking cessation medications on
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
Official title: Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: number of drinks consumed
tobacco and alcohol craving
tobacco and alcohol craving
Minimum age: 21 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory, New Haven, Connecticut 06519, United States
Starting date: April 2007
Last updated: April 13, 2015