Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
First received: October 22, 2009
Last updated: May 6, 2016
Last verified: May 2016
The purpose of this study is the examine the effect of varenicline on reactivity to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.

Condition Intervention Phase
Alcohol Reactivity
Drug: varenicline
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Varenicline on Fixed-Dose Alcohol Administration in Participants With Alcohol Use Disorders

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • objective (cognitive function, psychomotor response, physiological reactivity, blood alcohol levels, adverse events) and subjective (craving, mood, intoxication, stimulation, sedation) reactivity to alcohol [ Time Frame: during the fixed dose alcohol sessions ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: varenicline
varenicline 1mg/day or 2mg/day
Drug: varenicline
1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.
Other Name: Chantix
Placebo Comparator: placebo
Drug: placebo


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 21 years old or older
  • Able to read and write in English
  • Smokers and nonsmokers
  • Meet criteria for alcohol use disorders
  • Currently enrolled in NCT00580645

Exclusion Criteria:

  • Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol
  • Significant hepatocellular injury
  • Positive test results 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
  • 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 protocol
  • Subjects likely to exhibit clinically significant alcohol withdrawal during the study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01000987

United States, Connecticut
Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Principal Investigator: Sherry A McKee, PhD Yale University
  More Information

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01000987     History of Changes
Other Study ID Numbers: 0907005525 
Study First Received: October 22, 2009
Last Updated: May 6, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Yale University:
smoking cessation medications

Additional relevant MeSH terms:
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016