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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00580645
First received: December 25, 2007
Last updated: April 8, 2014
Last verified: April 2014

December 25, 2007
April 8, 2014
April 2007
December 2015   (final data collection date for primary outcome measure)
number of drinks consumed [ Time Frame: throughout the laboratory session ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00580645 on ClinicalTrials.gov Archive Site
  • tobacco and alcohol craving [ Time Frame: during laboratory session ] [ Designated as safety issue: No ]
  • tobacco and alcohol craving [ Time Frame: during the cue reactivity session ] [ Designated as safety issue: No ]
tobacco and alcohol craving [ Time Frame: during laboratory session ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Drinking
  • Drug: varenicline

    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.

    Other Name: Chantix
  • Drug: bupropion
    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.
    Other Name: Zyban
  • Drug: placebo
    placebo
  • Experimental: varenicline

    Studies 1A and 1B: varenicline 2mg/day

    Study 1C: varenicline 1mg/day or 2mg/day

    Intervention: Drug: varenicline
  • Experimental: Bupropion
    Study 1A only: Bupropion 300mg/day
    Intervention: Drug: bupropion
  • Placebo Comparator: Placebo
    Placebo Controlled
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
308
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580645
HIC0702002391, R01AA015596-01
Yes
Sherry McKee, Yale University
Yale University
Not Provided
Principal Investigator: Sherry A McKee, PhD Yale University
Yale University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP