NCT00595556

Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.

Detailed description

Zonisamide is an antiepileptic medication which has similar clinical and pharmacologic effects to topiramate, a medication that has demonstrated efficacy in a randomized clinical trial for treatment of alcoholism. Because zonisamide is potentially better tolerated and easier to titrate in the outpatient setting than topiramate, it may offer important clinical advantages in the treatment of alcoholism. This is a small 12-week placebo-controlled pilot study examining tolerability and potential efficacy in anticipation of a larger, placebo-controlled trial of zonisamide for treatment of alcohol dependence. It is a randomized, double-blind trial of zonisamide vs. placebo at flexible dosages of 100-500mg/day in alcoholics receiving ambulatory psychosocial treatment. Participants will take part in six individual Cognitive-Behavioral based therapy sessions, which are focused on learning coping skills. Participants must endorse a goal of either cutting down their drinking to non-hazardous levels, or abstinence.

Conditions

• Alcoholism
• Alcohol Abuse
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	zonisamide	flexible dosages of 100-500mg/day
DRUG	Placebo	Placebo

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-01-16
• Last updated: 2010-10-15
• Results posted: 2010-10-15

Locations

1 site across 1 country: United States