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

Vyne Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Alcohol Dependence

Treatments: Drug: Comparator: MK0594 5 mg/day; Drug: Comparator: Placebo to MK0594; Drug: Comparator: MK0594 1 mg/week; Drug: Comparator: MK0594 1 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00835718

2009_533

MK0594-020

0594-020

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 5 patient groups, including a placebo group

Stage I, Arm 1

Experimental group

Description:

MK0594 5 mg/day

Treatment:

Drug: Comparator: MK0594 5 mg/day

Stage I, Arm 2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo to MK0594

Stage II, Arm 2

Experimental group

Description:

MK0594 1 mg/day

Treatment:

Drug: Comparator: MK0594 1 mg/day

Stage II, Arm 3

Experimental group

Description:

MK0594 1 mg/week

Treatment:

Drug: Comparator: MK0594 1 mg/week

Stage II, Arm 4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo to MK0594