CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Levetiracetam XR +3 moredrug
Likely dose
Levetiracetam XR 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00970814
NCT00970814Phase 2Completed
CompareCT.gov

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Sep 2, 2009·Updated Aug 28, 2014

In Brief

A Phase 2 clinical trial evaluating BBCET, Levetiracetam XR, and 1 other intervention for Alcoholism. Completed, enrolled 130 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.8 years ago

Interventions

BBCETbehavioral

11 BBCET sessions

BBCETbehavioral

11 BBCET Sessions

Levetiracetam XRdrug

500mg - 2000mg Once per day 16 weeks

Sugar Pilldrug

500mg - 2000mg Once per day 16 weeks