Levetiracetam XR in Very Heavy Drinkers
Condition: Alcoholism
MeSH terms: Alcoholism; Alcoholic Intoxication
Intervention: BBCET; BBCET; Levetiracetam XR; Sugar Pill
Intervention description: 11 BBCET sessions; 11 BBCET Sessions; 500mg - 2000mg Once per day 16 weeks; 500mg - 2000mg Once per day 16 weeks
Intervention MeSH terms: Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcoholism; Alcohol Drinking; Alcoholic Intoxication; Alcohol Abuse

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).
    

Eligibility 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.