Levetiracetam XR in Very Heavy Drinkers

Study Overview
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Brief Summary
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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).

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

Conditions
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Alcoholism

Intervention / Treatment
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* Behavioral: BBCET
* Behavioral: BBCET
* Drug: Levetiracetam XR
* Drug: Sugar Pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 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. | 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. | based on self report | Study Weeks 5-14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, Alcohol Drinking, Alcoholic Intoxication, Alcohol Abuse