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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000987
First Posted: October 23, 2009
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sherry McKee, Yale University
  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
Intervention Model: Factorial Assignment
Masking: Triple (Participant, 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 Sherry McKee, 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 ]

Enrollment: 44
Study Start Date: October 2009
Study Completion Date: November 2016
Primary Completion Date: November 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
placebo
Drug: placebo
placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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 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
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): NCT01000987


Locations
United States, Connecticut
Yale Center for Clinical Investigation, Yale Human Behavioral Pharmacology Laboratory
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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
First Submitted: October 22, 2009
First Posted: October 23, 2009
Last Update Posted: November 23, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
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