Clinical trial NCT00580645: Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Official title: Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Drinking
Keywords: alcohol
smoking cessation
varenicline
bupropion
smoking cessation medications
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2007-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Drinks Consumed
timeFrame: 2 hour ad-lib drinking period, during the laboratory session (Day 8)
Secondary outcomes:
measure: Alcohol Craving
timeFrame: during laboratory session (Day 8) at baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161.