Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: SCH 900435; Placebo
Intervention description: tablets; tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on
      heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol
      dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent after the scope and nature of the investigation, have
             been explained to the participant before screening;

          -  Diagnosis of alcohol dependence - meeting at least 5 out of 7 criteria according to
             Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
             (DSM-IV-TR) specifier; one of which should be criterion 1 (tolerance) or 2
             (withdrawal);

          -  Primary complaints according to Mini-International Neuropsychiatric Interview (MINI)
             should be alcohol problems;

          -  Participants must have gone through a detoxification program, have a clearly stated
             desire to stay abstinent and present at baseline with the following: be alcohol
             abstinent for at least 3 days, benzodiazepine free for at least 3 days, and a Clinical
             Institute Withdrawal Assessment (CIWA) score <10;

          -  Age 18-65 years at screening;

          -  Males, or females who are not of childbearing potential (i.e., surgically sterile,
             postmenopausal for at least one year) or who are non-pregnant, non-lactating and using
             a medically accepted method of contraception; these include condoms with or without a
             spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed
             intrauterine device (IUD), and hormonal contraceptives;

          -  Body Mass Index (BMI) >16 kg/m^2;

          -  Breath alcohol concentration < 0.02% (at screening and baseline)

        Exclusion Criteria:

          -  Participants requiring pharmacological treatment for a primary diagnosis of major
             depressive disorder, anxiety, panic disorder or social phobia;

          -  Participants with psychotic disorders (according to MINI);

          -  Participants with a medium or high suicidality risk (as assessed by MINI)

          -  Active substance abuse (resulting in either physical or mental damage as defined by
             International Statistical Classification of Diseases and Related Health Problems, 10th
             revision [ICD10] or dependence other than alcohol (excluding nicotine) within 12
             months prior to screening, e.g. cannabis, benzodiazepine, amphetamines,
             chlo(r)methiazole, opiates, cocaine, hallucinogens or other substances;

          -  Use of one of the following drugs during the last 14 days prior to screening:
             cannabis, amphetamines, opiates, cocaine, hallucinogens;

          -  Use of any medication that can have an effect on alcohol consumption within 30 days of
             study initiation, including naltrexone, acamprosate, disulfiram, ondansetron,
             topiramate, selective serotonin reuptake inhibitors (SSRIs), mirtazapine,
             varencicline, gabapentin, levetiracetam;

          -  A clinically relevant visual disturbance, such as cataract, color blindness, macular
             degeneration, glaucoma or retinal disease;

          -  Untreated or uncompensated clinically significant renal, endocrine, hepatic,
             respiratory, cardiovascular, hematological, immunological or cerebrovascular disease,
             malignancy, or other chronic and/or degenerative process at screening;

          -  Any clinically meaningful abnormal laboratory, vital sign, physical examination or
             electrocardiogram (ECG) finding which, in the opinion of the investigator, may
             interfere with the interpretation of safety or efficacy evaluations;

          -  QTc interval (Fridericia corrected) at screening >450 ms (male), >470 ms (female);

          -  Serious neuropsychiatric condition that can impair judgment or cognitive function
             (including dementia or amnestic disorder) to an extent that providing informed consent
             or complying with treatment is precluded;

          -  History or present evidence of epileptic disorders or withdrawal seizures;

          -  History of substance withdrawal delirium;

          -  Breast-feeding woman, or a positive result of urine pregnancy test (at screening), or
             plan to become pregnant during the course of the trial (females only);

          -  Pending legal charges with the potential for incarceration, probation, or parole;

          -  Homelessness (less than 2 months stable residence);

          -  Participation in a clinical trial during the 3 months prior to screening.