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

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

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?

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Quitting Smoking Smoking

Drug Information available for: Ethanol Bupropion hydrochloride Bupropion Varenicline

U.S. FDA Resources

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

No publications provided

Responsible Party:	Yale University School of Medicine ( Sherry McKee, PhD )
Study ID Numbers:	HIC0702002391, R01AA015596-01
Study First Received:	December 25, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00580645 History of Changes
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:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Drinking Behavior
Psychotropic Drugs
Alcohol Drinking
Varenicline
Smoking

Dopamine
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Ethanol

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Drinking Behavior
Psychotropic Drugs
Alcohol Drinking

Pharmacologic Actions
Therapeutic Uses
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009