Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
Information source: Yale University
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Drinking
Intervention: varenicline (Drug); bupropion (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University
Overall contact:
Naralys Estevez, Phone: 203-974-7555
Summary
The purpose of this study is to examine the effect of smoking cessation medications on
alcohol drinking. Volunteers are administered either varenicline (Chantix), bupropion
(Zyban), or placebo.
Clinical Details
Official title: Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 2: Do Varenicline (Chantix) and Bupropion (Zyban) Change Alcohol Drinking?
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment
Primary outcome: number of drinks consumed
Secondary outcome: tobacco and alcohol craving
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 21 years old or older
- Able to read and write in English
- 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
Locations and Contacts
Naralys Estevez, Phone: 203-974-7555
Connecticut Mental Health Center & Yale/New Haven Hospital, New Haven, Connecticut 06519, United States; Recruiting
Sherry A McKee, PhD, Principal Investigator
Additional Information
Starting date: April 2007
Ending date: December 2011
Last updated: December 26, 2007
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