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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-27

Study Completion Date

2010-03-11

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.

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Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Stage I, Arm 1

MK0594 5 mg/day

Group Type EXPERIMENTAL

Comparator: MK0594 5 mg/day

Intervention Type DRUG

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.

Stage I, Arm 2

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo to MK0594

Intervention Type DRUG

Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

Stage II, Arm 2

MK0594 1 mg/day

Group Type EXPERIMENTAL

Comparator: MK0594 1 mg/day

Intervention Type DRUG

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.

Stage II, Arm 3

MK0594 1 mg/week

Group Type EXPERIMENTAL

Comparator: MK0594 1 mg/week

Intervention Type DRUG

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.

Stage II, Arm 4

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo to MK0594

Intervention Type DRUG

Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

Interventions

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Comparator: MK0594 5 mg/day

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.

Intervention Type DRUG

Comparator: MK0594 1 mg/day

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.

Intervention Type DRUG

Comparator: MK0594 1 mg/week

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.

Intervention Type DRUG

Comparator: Placebo to MK0594

Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

Intervention Type DRUG

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No