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

This study is currently recruiting participants.
Verified February 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT01000987
First received: October 22, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Alcohol
U.S. FDA Resources

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 2014
Estimated Primary Completion Date: August 2014 (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
placebo
 Drug: placebo
placebo
Other Name: placebo

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000987

Contacts
Contact: Sabrina Coppola 203-737-2827

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

No publications provided

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: February 21, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Yale University:
alcohol
reactivity
smoking cessation medications

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

ClinicalTrials.gov processed this record on May 21, 2013