Levetiracetam XR in Very Heavy Drinkers

Phase 2

Completed

Conditions: Alcoholism

Interventions: Behavioral: BBCET
Drug: Levetiracetam XR
Drug: Sugar Pill

Registration Number: NCT00970814

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

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

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
- patch
- barrier (diaphragm or condom)
- intrauterine contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse, and/or
- hormonal vaginal contraceptive ring.
The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
The subject must complete all psychological assessments required at screening and baseline.
The subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. Subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment.
The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levetiracetam XR	BBCET	Group received Levetiracetam
Levetiracetam XR	Levetiracetam XR	Group received Levetiracetam
Sugar Pill	BBCET	Placebo
Sugar Pill	Sugar Pill	Placebo

Primary Outcome Measures

Name	Time	Method
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.	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.	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 Outcome Measures

Name	Time	Method
The Number of Drinks Per Drinking Day Study Weeks 5-14.	Study Weeks 5-14	based on self report

Trial Locations

Locations (5): Boston University School of Medicine
🇺🇸
Boston, Massachusetts, United States
University Of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Johns Hopkins School of Medicine
🇺🇸
Baltimore, Maryland, United States
Dartmouth Medical School
🇺🇸
Lebanon, New Hampshire, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States