A Study of MK0594 in Patients With Alcohol Dependence

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00835718
First received: February 3, 2009
Last updated: March 26, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Drug: Comparator: MK0594 5 mg/day
Drug: Comparator: MK0594 1 mg/day
Drug: Comparator: MK0594 1 mg/week
Drug: Comparator: Placebo to MK0594
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination [ Time Frame: week 3 and 12 adrer starting study medication for efficacy and over 12 weeks and 52 weeks for safety ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • no alcohol drinking [ Time Frame: week 3 to 12 after starting study medication and over 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: February 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage I, Arm 1
MK0594 5 mg/day
Drug: 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.
Placebo Comparator: Stage I, Arm 2
Placebo
Drug: Comparator: Placebo to MK0594
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
Experimental: Stage II, Arm 2
MK0594 1 mg/day
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.
Experimental: Stage II, Arm 3
MK0594 1 mg/week
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.
Placebo Comparator: Stage II, Arm 4
Placebo
Drug: Comparator: Placebo to MK0594
Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has DSM-IV-TR 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835718

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00835718     History of Changes
Other Study ID Numbers: 2009_533, MK0594-020
Study First Received: February 3, 2009
Last Updated: March 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014