Phase 2 N=60 Randomized Triple-blind Treatment

Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Alcohol Drinking

Bottom Line

View on ClinicalTrials.gov: NCT00580645 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Number of Drinks Consumed — 2.1; 2.05; 1.5; 1.7 number of drinks

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: varenicline (Drug); placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Drinks Consumed	2.1; 2.05; 1.5; 1.7; 2.05; 1.5	—
SECONDARY Alcohol Craving	37.24; 34.11; 24.04	—

Summary

The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated. Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior. Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00580645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.