Levetiracetam XR in Very Heavy Drinkers (NCIG 002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00970814
First received: September 1, 2009
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Alcoholism
Behavioral: BBCET
Drug: Levetiracetam XR
Drug: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy Of Levetiracetam Extended Release in Very Heavy Drinkers

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14. [ Time Frame: Weeks 5-14 ] [ Designated as safety issue: No ]
    A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.

  • The Weekly Percentage of Heavy Drinking Days During Study Weeks 5 Through 14. [ Time Frame: Study Weeks 5-14 ] [ Designated as safety issue: No ]
    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:
  • The Number of Drinks Per Drinking Day Study Weeks 5-14. [ Time Frame: Study Weeks 5-14 ] [ Designated as safety issue: No ]
    based on self report


Enrollment: 130
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levetiracetam XR
Group received Levetiracetam
Behavioral: BBCET
11 BBCET sessions
Drug: Levetiracetam XR
500mg - 2000mg Once per day 16 weeks
Placebo Comparator: Sugar Pill
Placebo
Behavioral: BBCET
11 BBCET Sessions
Drug: Sugar Pill
500mg - 2000mg Once per day 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970814

Locations
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New Hampshire
Dartmouth Medical School
Lebanon, New Hampshire, United States, 03755
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
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)
  More Information

Publications:
Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00970814     History of Changes
Other Study ID Numbers: NIAAA_DTRR-2009-LITTEN-02
Study First Received: September 1, 2009
Results First Received: April 26, 2012
Last Updated: May 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcoholism
Alcohol Drinking
Alcoholic Intoxication
Alcohol Abuse

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014