A Study of MK0594 in Patients With Alcohol Dependence - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00835718

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 II

MedlinePlus related topics: Alcoholism

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

to evaluate alcohol use, craving, and clinical improvement including 1) daily alcohol use as assessed by timeline-follow-back (TLFB) at scheduled visits; 2) Alcohol Urge Questionnaire [ Time Frame: at 12 weeks and at 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

medical and psychiatric history; physical and neurological examination, vital signs and orthostatic vital signs; resting 12-lead ECG; laboratory safety tests including CBC, serum chemistry, endocrine, and urinalysis [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stage I, Arm 1: Experimental M0594 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.
Stage I, Arm 2: Placebo Comparator Placebo	Drug: Comparator: Placebo to MK0594 Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
Stage II, Arm 1: Experimental 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.
Stage II, Arm 2: Experimental 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.
Stage II, Arm 3: Experimental 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.
Stage II, Arm 4: Placebo Comparator 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 in that 30 days
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

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

Belgium
Merck Sharp & Dohme B.V.	Recruiting
Bruxelles, Belgium, 1180
Contact: Nathalie Schrameijer 32-2-373-4310
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs 33-1-4754-89-90

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_533, MK0594-020
Study First Received:	February 3, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00835718 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mental Disorders
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:

Mental Disorders
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 07, 2009