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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 February 07, 2013
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:
Sabrina Coppola, Phone: 203-737-2783

Summary

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.

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: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: number of drinks consumed

Secondary outcome:

tobacco and alcohol craving

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, 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

Locations and Contacts

Sabrina Coppola, Phone: 203-737-2783

Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory, New Haven, Connecticut 06519, United States; Recruiting
Sherry A McKee, PhD, Principal Investigator
Additional Information

Starting date: April 2007
Last updated: July 5, 2012

Page last updated: February 07, 2013

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