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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014