Who is sponsoring NCIG 002?

NCIG 002 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

What drugs are being tested in NCIG 002?

Interventions: BBCET, BBCET, Levetiracetam XR, Sugar Pill.

What is the status of NCIG 002?

NCIG 002 is currently COMPLETED.

Last reviewed 2014-08-20 · How we verify

A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers (NCIG 002)

NCT00970814 Phase 2 COMPLETED Results posted

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).

Details

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase	Phase 2
Status	COMPLETED
Enrolment	130
Start date	2009-10
Completion	2010-10

Conditions

Alcoholism

Interventions

BBCET
BBCET
Levetiracetam XR
Sugar Pill

Primary outcomes

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.
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.

Countries

United States