Alcohol Dependence
Conditions
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.
Interventions
DRUGComparator: 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.
DRUGComparator: 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.
DRUGComparator: 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.
DRUGComparator: Placebo to MK0594
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
Sponsors
Vyne Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| no alcohol drinking | week 3 to 12 after starting study medication and over 52 weeks | no alcohol drinking |
Outcome results
None listed