A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers
Overview
- Phase
- Phase 2
- Intervention
- BBCET
- Conditions
- Alcoholism
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Enrollment
- 130
- Locations
- 5
- Primary Endpoint
- The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject must be at least 18 years of age.
- •The subject must have a DSM-IV diagnosis of current alcohol dependence.
- •The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
- •The subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- •If the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal:
- •oral contraceptives
- •contraceptive sponge
- •barrier (diaphragm or condom)
- •intrauterine contraceptive system
- •levonorgestrel implant
Exclusion Criteria
- Not provided
Arms & Interventions
Levetiracetam XR
Group received Levetiracetam
Intervention: BBCET
Levetiracetam XR
Group received Levetiracetam
Intervention: Levetiracetam XR
Sugar Pill
Placebo
Intervention: BBCET
Sugar Pill
Placebo
Intervention: Sugar Pill
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- The Number of Drinks Per Drinking Day Study Weeks 5-14.(Study Weeks 5-14)