A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK-0594 in Patients with Alcohol Dependence

Phase 1

• Conditions: Alcohol Dependence; MedDRA version: 9.1Level: LLTClassification code 10001594Term: Alcohol dependence syndrome

• Registration Number: EUCTR2008-004686-26-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., U.S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-13
• Study Completion: 2010-03-11
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patient has a DSM-IV-TR diagnosis of alcohol dependence, and alcohol addiction is the patient's primary complaint among substance use disorders and patient is not in remission.

If applicable, dose of medically prescribed daily psychotropic medications has been unchanged for at least four weeks.

Patients has negative urine toxicological screen for opiates, stimulants, and sedative-hypnotics, unless medically prescribed.

Patient has stable residence in the 2 months prior to screening visit, no unresolved legal problems that may impact participation in the study and has reasonable transportation arrangements to the study site and has no plans to move for the study duration.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient anticipates inpatient or residential alcohol treatment or is required to receive treatment by a court of law or involuntarily committed to treatment.

Patient has been hospitalized for alcohol withdrawal delirium in the past year or ever experienced seizure, alcohol-induced persisting dementia or amnestic disorder, or alcohol-induced psychotic disorder.

Patient has a history of suicide attempt within the last year or has clinically significant suicidal or homicidal ideation at screening, as assessed by the investigator.

Patient has current or lifetime diagnosis of schizophrenia or bipolar I disorder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified