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

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.