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Do Treatments for Smoking Cessation Affect Alcohol Drinking?

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ClinicalTrials.gov Identifier: NCT00580645
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

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.


Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: varenicline Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Actual Study Start Date : April 2007
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: varenicline
varenicline 1mg/day or 2mg/day
Drug: varenicline
2mg/day or 1mg/day with 1-week medication lead-in period.
Other Name: Chantix

Placebo Comparator: Placebo
Placebo Controlled
Drug: placebo
placebo




Primary Outcome Measures :
  1. Number of Drinks Consumed [ Time Frame: 2 hour ad-lib drinking period, during the laboratory session (Day 8) ]
    number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session


Secondary Outcome Measures :
  1. Alcohol Craving [ Time Frame: during laboratory session (Day 8) at baseline ]
    alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580645


Locations
United States, Connecticut
Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Sherry A McKee, PhD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00580645     History of Changes
Other Study ID Numbers: HIC0702002391
R01AA015596-01 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2007    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018

Keywords provided by Sherry McKee, Yale University:
alcohol
smoking cessation
varenicline
bupropion
smoking cessation medications

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Varenicline
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action