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

Sponsor:	Yale University
Information provided by (Responsible Party):	Sherry McKee, Yale University
ClinicalTrials.gov Identifier:	NCT00580645

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Varenicline tartrate

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 ]
tobacco and alcohol craving [ Time Frame: during the cue reactivity session ] [ Designated as safety issue: No ]

Estimated Enrollment:	308
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: varenicline Studies 1A and 1B: varenicline 2mg/day Study 1C: varenicline 1mg/day or 2mg/day	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
Experimental: Bupropion Study 1A only: Bupropion 300mg/day	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
Placebo Comparator: Placebo 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, 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

Contacts and Locations

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

Contacts

Contact: Sabrina Coppola

203-737-2783

Locations

United States, Connecticut
Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory	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:	Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:	NCT00580645 History of Changes
Other Study ID Numbers:	HIC0702002391, R01AA015596-01
Study First Received:	December 25, 2007
Last Updated:	January 20, 2012
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Yale University:

alcohol
smoking cessation
varenicline
bupropion
smoking cessation medications

Additional relevant MeSH terms:

Alcohol Drinking
Smoking
Drinking Behavior
Habits
Ethanol
Bupropion
Varenicline
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs

Central Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 07, 2012