NCT00705523

Varenicline (Chantix™) for the Treatment of Alcohol Dependence

A Phase II, Randomized, Double-Blind Pilot Trial of Varenicline (Chantix™) for the Treatment of Alcohol Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the treatment of alcohol dependence.

Detailed description

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.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	varenicline	1.0 mg BID for 12 weeks
DRUG	placebo	BID 12 weeks

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-03-01
• Completion: 2011-12-01
• First posted: 2008-06-26
• Last updated: 2015-06-02
• Results posted: 2015-06-02

Locations

1 site across 1 country: United States