A Study of MK0594 in Patients With Alcohol Dependence


Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateOctober 2014   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 28, 2009)		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 ]
Original Primary Outcome Measures  ICMJE 
 (submitted: February 3, 2009)		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 ]
Change HistoryComplete list of historical versions of study NCT00835718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 28, 2009)		no alcohol drinking [ Time Frame: week 3 to 12 after starting study medication and over 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: February 3, 2009)		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 ]

Descriptive Information

Brief Title  ICMJEA Study of MK0594 in Patients With Alcohol Dependence
Official Title  ICMJEA Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence
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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAlcohol Dependence
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • Drug: Comparator: Placebo to MK0594
    Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.
Study Arms / Comparison Groups
  • Stage I, Arm 1: Experimental
    MK0594 5 mg/day
    Intervention: Drug: Comparator: MK0594 5 mg/day
  • Stage I, Arm 2: Placebo Comparator
    Placebo
    Intervention: Drug: Comparator: Placebo to MK0594
  • Stage II, Arm 2: Experimental
    MK0594 1 mg/day
    Intervention: Drug: Comparator: MK0594 1 mg/day
  • Stage II, Arm 3: Experimental
    MK0594 1 mg/week
    Intervention: Drug: Comparator: MK0594 1 mg/week
  • Stage II, Arm 4: Placebo Comparator
    Placebo
    Intervention: Drug: Comparator: Placebo to MK0594

Recruitment Information

Estimated Enrollment  ICMJE1500
Estimated Completion DateOctober 2014
Estimated Primary Completion DateOctober 2014   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages21 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Belgium,   France,   Germany,   Russian Federation,   Spain

Administrative Information

NCT ID  ICMJENCT00835718
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2009_533, MK0594-020
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck