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

This study is currently recruiting participants.
Verified by Yale University, July 2008

Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00580645
  Purpose

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.


Condition Intervention Phase
Alcohol Drinking
Drug: varenicline
Drug: bupropion
Drug: placebo
Phase II

MedlinePlus related topics:   Alcohol Consumption    Smoking    Smoking Cessation   

ChemIDplus related topics:   Varenicline    Bupropion hydrochloride    Bupropion    Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment
Official Title:   Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?

Further study details as provided by Yale University:

Primary Outcome Measures:
  • number of drinks consumed [ Time Frame: throughout the laboratory session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • tobacco and alcohol craving [ Time Frame: during laboratory session ] [ Designated as safety issue: No ]

Estimated Enrollment:   72
Study Start Date:   April 2007
Estimated Study Completion Date:   December 2011
Estimated Primary Completion Date:   December 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
varenicline: Experimental
varenicline 2mg/day
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).
Bupropion: Experimental
Bupropion 300mg/day
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).
Placebo: Placebo Comparator
Placebo Controlled
Drug: placebo
placebo

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580645

Contacts
Contact: Erika Balchunas     203-737-2783    

Locations
United States, Connecticut
Connecticut Mental Health Center & Yale/New Haven Hospital     Recruiting
      New Haven, Connecticut, United States, 06519
      Principal Investigator: Sherry A McKee, PhD            

Sponsors and Collaborators
Yale University

Investigators
Principal Investigator:     Sherry A McKee, PhD     Yale University    
  More Information

Responsible Party:   Yale University School of Medicine ( Sherry McKee, PhD )
Study ID Numbers:   HIC0702002391, R01AA015596-01
First Received:   December 25, 2007
Last Updated:   July 31, 2008
ClinicalTrials.gov Identifier:   NCT00580645
Health Authority:   United States: Institutional Review Board

Keywords provided by Yale University:
alcohol  
smoking cessation  
varenicline  
bupropion  
smoking cessation medications  

Study placed in the following topic categories:
Smoking
Dopamine
Bupropion
Drinking Behavior
Alcohol Drinking
Ethanol

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on August 21, 2008




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