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Levetiracetam XR in Very Heavy Drinkers

NCT00970814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-08-28

Study results available
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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

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    lead NIH

Principal Investigators

  • Raye Z Litten, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • Margaret M Mattson, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • Joanne E Fertig, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00970814 on ClinicalTrials.gov