A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence|
- Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
- Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12. [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
- Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study. [ Time Frame: Week 1 to Week 12 ] [ Designated as safety issue: No ]Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.
|Study Start Date:||January 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Drug: varenicline (Chantix) 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).
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).
Other Name: Chantix
Placebo Comparator: placebo
Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
Other Name: Placebo
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.
|United States, California|
|UCSF: Ernest Gallo Clinic and Research Center|
|Emeryville, California, United States, 94608|
|Principal Investigator:||Howard Fields, MD PhD||UCSF: Ernest Gallo CLinic and Research Center|
|Study Director:||Jennifer Mitchell, PhD||UCSF: Ernest Gallo Clinic and Research Center|