A Study of MK0594 in Patients With Alcohol Dependence (0594-020)

Study Overview
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Brief Summary
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A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.

Official Title
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A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Comparator: MK0594 5 mg/day
* Drug: Comparator: MK0594 1 mg/day
* Drug: Comparator: MK0594 1 mg/week
* Drug: Comparator: Placebo to MK0594


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction Patient has two heavy drinking days in the last 30 days Patient has 3 days of abstinence from alcohol right before taking study medication Patient has lived in the same residence for the last 2 months Exclusion Criteria: If female, patient is pregnant or breastfeeding Patient anticipated inpatient alcohol treatment Patient has a history of suicide attempt in the last year Patient has schizophrenia or bipolar disorder Patient has a history of multiple or serious allergies Patient has participated in a clinical trial in the last 30 days

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage I, Arm 1<br>MK0594 5 mg/day | Drug: Comparator: MK0594 5 mg/day<br>* MK0594 5 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 15 mg MK0594 will be administered.<br>|
| Placebo Comparator: Stage I, Arm 2<br>Placebo | Drug: Comparator: Placebo to MK0594<br>* Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.<br>|
| Experimental: Stage II, Arm 2<br>MK0594 1 mg/day | Drug: Comparator: MK0594 1 mg/day<br>* MK0594 1 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.<br>|
| Experimental: Stage II, Arm 3<br>MK0594 1 mg/week | Drug: Comparator: MK0594 1 mg/week<br>* MK0594 1 mg tablets taken orally once every 7 days for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.<br>|
| Placebo Comparator: Stage II, Arm 4<br>Placebo | Drug: Comparator: Placebo to MK0594<br>* Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination | no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination | week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no alcohol drinking | no alcohol drinking | week 3 to 12 after starting study medication and over 52 weeks |