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

This study is currently recruiting participants.

Verified January 2012 by Yale University

First Received on October 22, 2009. Last Updated on January 20, 2012 History of Changes

Sponsor:	Yale University
Information provided by (Responsible Party):	Sherry McKee, Yale University
ClinicalTrials.gov Identifier:	NCT01000987

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

Drug Information available for: Varenicline Varenicline tartrate

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 2013
Estimated Primary Completion Date:	August 2013 (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:	January 20, 2012
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 23, 2012