Overview

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.