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Status:

COMPLETED

Levetiracetam XR in Very Heavy Drinkers

Lead Sponsor:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcoholism

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • The subject must be at least 18 years of age.
  • The subject must have a DSM-IV diagnosis of current alcohol dependence.
  • The subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking.
  • 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.
  • 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.
  • The subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
  • The subject must complete all psychological assessments required at screening and baseline.
  • 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.
  • The subject must have a breath alcohol concentration (BAC) equal to 0.000 when s/he signed the informed consent document.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2010

    Estimated Enrollment :

    130 Patients enrolled

    Trial Details

    Trial ID

    NCT00970814

    Start Date

    October 1 2009

    End Date

    October 1 2010

    Last Update

    August 28 2014

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Johns Hopkins School of Medicine

    Baltimore, Maryland, United States, 21224

    2

    Boston University School of Medicine

    Boston, Massachusetts, United States, 02118

    3

    Dartmouth Medical School

    Lebanon, New Hampshire, United States, 03755

    4

    University Of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104