Levetiracetam XR in Very Heavy Drinkers (NCIG 002)

August 20, 2014 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03755
        • Dartmouth Medical School
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject must be at least 18 years of age.
  2. The subject must have a DSM-IV diagnosis of current alcohol dependence.
  3. The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
  4. 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.

  5. 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.
  6. The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
  7. The subject must complete all psychological assessments required at screening and baseline.
  8. 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.
  9. The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar Pill
Placebo
Behavioral: BBCET
11 BBCET sessions
Behavioral: BBCET
11 BBCET Sessions
Drug: Sugar Pill
500mg - 2000mg Once per day 16 weeks
Active Comparator: Levetiracetam XR
Group received Levetiracetam
Behavioral: BBCET
11 BBCET sessions
Behavioral: BBCET
11 BBCET Sessions
Drug: Levetiracetam XR
500mg - 2000mg Once per day 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weeks 5-14
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.
Study Weeks 5-14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Drinks Per Drinking Day Study Weeks 5-14.
Time Frame: Study Weeks 5-14
based on self report
Study Weeks 5-14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Raye Z Litten, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Principal Investigator: Margaret M Mattson, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Principal Investigator: Joanne E Fertig, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA_DTRR-2009-LITTEN-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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