Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Alcohol Drinking Clinical Trial

Official title:

Do Treatments for Smoking Cessation Affect Alcohol Drinking?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580645
• Other study ID #: HIC0702002391
• Secondary ID: R01AA015596-01
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2007
• Last updated: January 8, 2018
• Start date: April 2007
• Est. completion date: November 2016

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• varenicline
2mg/day or 1mg/day with 1-week medication lead-in period.
• placebo
placebo

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Drinks Consumed	number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session	2 hour ad-lib drinking period, during the laboratory session (Day 8)
Secondary	Alcohol Craving	alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)	during laboratory session (Day 8) at baseline