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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00705523 |
The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.
Condition | Intervention | Phase |
---|---|---|
Alcoholism |
Drug: varenicline Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence |
Estimated Enrollment: | 40 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: varenicline
1.0 mg BID for 12 weeks
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2: Placebo Comparator |
Drug: placebo
BID 12 weeks
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By both providing a low level of reinforcement and down-grading any "high" associated with concurrent administration of the abused drug, combined agonist/antagonist therapies promote both initial and sustained abstinence. Based on varenicline's specific affinity for the nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors. That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural reward circuitry activated by alcohol use.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania Treatment Research Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jennifer G Plebani, PhD 215-222-3200 ext 152 plebani_j@mail.trc.upenn.edu | |
Principal Investigator: Jennifer G Plebani, PhD | |
Sub-Investigator: Kyle M Kampman, MD |
Principal Investigator: | Jennifer G Plebani, PhD | University of Pennsylvania, Treatment Research Center |
Responsible Party: | University of Pennsylvania ( Jennifer G. Plebani, Ph.D. ) |
Study ID Numbers: | ChA - 807226 |
Study First Received: | June 24, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00705523 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
alcohol treatment nicotinic acetylcholine receptors pharmacotherapy outpatient |
Mental Disorders Alcoholism Substance-Related Disorders Disorders of Environmental Origin |
Acetylcholine Alcohol-Related Disorders Ethanol |