Dependencia Alcohólica Alcohol Dependence MedDRA version: 9.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome
Conditions
Interventions
Product Name: MK-0594
Product Code: MK-0594
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: serlopitant
CAS Number: 860642-69-9
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluate efficacy of MK-0594 in maintaining abstinence over Weeks 3-12 of a 12-week treatment period;Primary end point(s): Maintained absence of heavy drinking;Main Objective: Evaluate efficacy of MK-0594 in maintaining absence of heavy alcohol drinking over Weeks 3-12 of a 12-week treatment period | — |
Countries
Belgium, France, Germany, Spain
Outcome results
None listed