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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Age between 21 and 75 years.

• Currently seeking treatment for nicotine dependence (smoke at least 10 cigarettes daily) and found to have problem drinking, alcohol abuse or alcohol dependence (non-physiological) as determined by amount of alcohol consumed weekly (Average weekly alcohol consumption (last 30 days), >7 standard drinks (for women) or >14 standard drinks (for men), clinical interview, and AUDIT score > 8.

• Generally healthy, without serious or unstable medical/mental illness(es).

• Smokers only will be included (degree of nicotine dependence will be assessed and included in analysis).

• Able to give voluntary, written, informed consent

Exclusion Criteria:

• More than 30 days of abstinence from alcohol in the prior 90 days.

• History of major alcohol-related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, liver function tests > 3 X ULN).

• Intolerance to the study medication.

• Current psychiatric disorder(s) requiring clinical treatment.

• Any recent history (i.e. within the preceding 5 years) of suicide attempt or current suicidal ideation.

• Use of illicit or non-prescribed psychotropic drug use (opiates, benzodiazepines, cocaine, PCP, methamphetamine, cocaine, or marijuana more than twice a week).

• A history of complicated alcohol or other drug withdrawal syndrome(s), e.g.: delirium tremens or seizures.