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A Study of MK0594 in Patients With Alcohol Dependence

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00835718
First Posted: February 4, 2009
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835718


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

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
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: March 30, 2010
Last Verified: March 2010

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