NCT01011907

A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence

Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.

Detailed description

Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical needs. Although there has been some progress with pharmacotherapy for alcohol-dependent individuals, a critical need for the development of novel and additional therapeutic approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had several recent advancements, where clinically as well as commercially successful additions to available treatment options are available and several more are expected in the near future. Based on recent preclinical work, we believe that varenicline has potential to become one of the first among those newly evolving treatments. In this study, participants with nicotine dependence will receive standard varenicline or placebo treatment over the recommended course of 12 weeks. Since our research question addresses whether alcohol drinking also diminishes with varenicline treatment, we will not ask participants to alter alcohol use; we will simply follow their use over time. Study visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be completed include vital signs, blood samples at screening and end of study, urine toxicology screening and the completion of standard questionnaires. No special facilities are required for these procedures. Group therapy (which is not a research procedure, but part of standard nicotine dependence treatment) will take place at the Gallo Center.

Conditions

• Substance Dependence

Interventions

Type	Name	Description
DRUG	varenicline	12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).
DRUG	placebo	12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-07-01
• Completion: 2012-06-01
• First posted: 2009-11-11
• Last updated: 2013-02-25
• Results posted: 2013-02-25

Locations

1 site across 1 country: United States