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

Completed · Not applicable · Has a placebo group

Conditions studied: Substance Dependence

In brief

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.

Key facts

Study ID

NCT01011907

Run by

University of California, San Francisco

People needed

99

Starts

2010-01-01

Expected to finish

2012-06-01

Last updated by the study team

2013-02-25

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCSF: Ernest Gallo Clinic and Research Center — Emeryville, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.