Clinical Trial: Levetiracetam XR in Very Heavy Drinkers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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).

Detailed Summary:
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Current Primary Outcome:

  • The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14. [ Time Frame: Weeks 5-14 ]
    A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
  • The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14. [ Time Frame: Study Weeks 5-14 ]
    A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.


Original Primary Outcome: Levetiracetam XR will increase the percentage of subjects with no heavy drinking days as compared to placebo during Study Weeks 5 through 14. Levetiracetam XR will decrease the weekly percentage of heavy drinking days during Study Weeks 5 through 14. [ Time Frame: Weeks 5-14 ]

Current Secondary Outcome: The Number of Drinks Per Drinking Day Study Weeks 5-14. [ Time Frame: Study Weeks 5-14 ]

based on self report


Original Secondary Outcome: Secondary efficacy outcome measures are intended to further explore drinking patterns, drinking consequence scores, and alcohol withdrawal symptoms. [ Time Frame: Study Weeks 1-19 ]

Information By: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Dates:
Date Received: September 1, 2009
Date Started: October 2009
Date Completion:
Last Updated: August 20, 2014
Last Verified: August 2014