Phase 2
Completed N=60
Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Alcohol Drinking
Source: ClinicalTrials.gov NCT00580645 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Number of Drinks Consumed — 2.1; 2.05; 1.5; 1.7 number of drinks
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.
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 | — |
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
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. Informational only — not medical advice.