Trial Investigating the Efficacy and Safety of Org 25935 in Relapse Prevention in Subjects With Alcohol Dependence (Study 172009)(P05718AM3) (OD-H)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00764660
First received: September 30, 2008
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to assess the effects of Org 25935 on heavy drinking and safety and tolerability of Org 25935 in subjects with alcohol dependence.


Condition Intervention Phase
Alcoholism
Drug: Org 25935
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of Org 25935 in Relapse Prevention in Subjects With Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of heavy drinking days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of drinking: drinks per day [ Time Frame: 12 weeks (for all secondary outcome measures) ] [ Designated as safety issue: No ]
  • Time to relapse and number of relapses into drinking [ Time Frame: 12 weeks (for all secondary outcome measures) ] [ Designated as safety issue: No ]
  • Cumulative abstinence duration [ Time Frame: 12 weeks (for all secondary outcome measures) ] [ Designated as safety issue: No ]
  • Global functioning [ Time Frame: 12 weeks (for all secondary outcome measures) ] [ Designated as safety issue: No ]
  • Craving - Mood - Motivation [ Time Frame: 12 weeks (for all secondary outcome measures) ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks (for all secondary outcome measures) ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Org 25935: a Glycine Uptake Inhibitor
Drug: Org 25935

12 mg BID, administered in tablets containing 4 mg of active substance in the morning and in the evening;

treatment duration: 12 weeks

Placebo Comparator: Arm 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent after the scope and nature of the investigation, have been explained to the subject before screening;
  • Diagnosis of alcohol dependence - meeting at least 5 out of 7 criteria according to 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;
  • Subjects 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 IUD, and hormonal contraceptives;
  • BMI > 16 kg/m^2;
  • Breath alcohol concentration < 0.02% (at screening and baseline)

Exclusion Criteria:

  • Subjects requiring pharmacological treatment for a primary diagnosis of major depressive disorder, anxiety, panic disorder or social phobia;
  • Subjects with psychotic disorders (according to MINI);
  • Subjects with a medium or high suicidality risk (as assessed by MINI)
  • Active substance abuse (resulting in either physical or mental damage as defined by 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, 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 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 three months prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00764660     History of Changes
Other Study ID Numbers: P05718, EudraCT #: 2008-005318-35, 172009
Study First Received: September 30, 2008
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 23, 2014