Levetiracetam XR in Very Heavy Drinkers (NCIG 002)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Alcoholism

Treatments: Drug: Levetiracetam XR; Drug: Sugar Pill; Behavioral: BBCET

Study type: Interventional

Funder types: NIH

Identifiers

NCT00970814

NIAAA_DTRR-2009-LITTEN-02

Details and patient eligibility

About

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).

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

130 participants in 2 patient groups, including a placebo group

Levetiracetam XR

Active Comparator group

Description:

Group received Levetiracetam

Treatment:

Drug: Levetiracetam XR

Behavioral: BBCET

Behavioral: BBCET

Sugar Pill

Placebo Comparator group

Description:

Placebo

Treatment:

Behavioral: BBCET

Behavioral: BBCET

Drug: Sugar Pill