NCT00970814

Levetiracetam XR in Very Heavy Drinkers

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to assess the efficacy of levetiracetam XR in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by DSM-IV criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).

Conditions

• Alcoholism

Interventions

Type	Name	Description
BEHAVIORAL	BBCET	11 BBCET sessions
BEHAVIORAL	BBCET	11 BBCET Sessions
DRUG	Levetiracetam XR	500mg - 2000mg Once per day 16 weeks
DRUG	Sugar Pill	500mg - 2000mg Once per day 16 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2010-10-01
• First posted: 2009-09-02
• Last updated: 2014-08-28
• Results posted: 2012-07-06

Locations

5 sites across 1 country: United States