Official Title: “Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?”

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking in nicotine-deprived smokers. Volunteers are administered either varenicline (Chantix), bupropion (Zyban), or placebo. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a single laboratory session assessing alcohol self-administration behavior.

Connected to this main trial are two additional arms for comparison-contrast purposes. The first arm comprises non-nicotine deprived heavy drinking smokers (n=20), randomized to varenicline (2mg/day) or placebo (0mg/day). The second arm involves heavy drinking non-smokers (n=20), randomized to varenicline (2mg/day) or placebo (0mg/day). All procedures for these additional arms are identical to the parent study.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment

Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

• Drug: varenicline
  • 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 during laboratory session (day 8).
• Drug: bupropion
  • 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).
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: varenicline
  • varenicline 2mg/day
• Experimental: Bupropion
  • Bupropion 300mg/day
• Placebo Comparator: Placebo
  • Placebo Controlled

Primary Measures

• number of drinks consumed
  • Time Frame: throughout the laboratory session
    Safety Issue?: No

Secondary Measures

• tobacco and alcohol craving
  • Time Frame: during laboratory session
    Safety Issue?: No

Inclusion Criteria:

• 21 years old or older
• Able to read and write in English
• Smokers or non-smokers
• Heavy Drinkers

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Sherry A McKee, PhD Principal Investigator Yale University  

Overall Contact: Erika Balchunas 203-737-2783 

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580645

Study ID Number: HIC0702002391

ClinicalTrials.gov Identifier: NCT00580645

Health Authority: United States: Institutional Review Board