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

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ClinicalTrials.gov Identifier: NCT01000987
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sherry McKee, Yale University

Brief Summary:
The purpose of this study is the examine the effect of varenicline on cognition 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 or disease Intervention/treatment Phase
Alcohol Reactivity Drug: varenicline Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel 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
Study Start Date : October 2009
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Cognitive Function as Measured by Omissions on the CPT [ Time Frame: Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption. ]
    Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324).



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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

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

Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01000987     History of Changes
Other Study ID Numbers: 0907005525
First Posted: October 23, 2009    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: January 2018

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