A Study of MK0594 in Patients With Alcohol Dependence (0594-020)
Phase 2
Terminated
- Conditions
- Alcohol Dependence
- Registration Number
- NCT00835718
- Lead Sponsor
- Vyne Therapeutics Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 162
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
- Secondary Outcome Measures
Name Time Method no alcohol drinking week 3 to 12 after starting study medication and over 52 weeks no alcohol drinking