Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)

NCT00764660 | Terminated Phase 2 Results

• 4 other identifiers: P057182008-005318-35172009MK-8435-003
• Study Type: interventional
• Target: 141
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• Percentage of Heavy Drinking Days

  Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use. A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol). Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval.

  12 weeks

Secondary Outcomes (13)

• Number of Drinks Per Drinking Day

  12 weeks

• Number of Relapses Into Heavy Drinking

  12 weeks

• Number of Lapses Into Any Drinking

  12 weeks

• Time to First Relapse Into Drinking

  12 weeks

• Percentage of Abstinent Days

  12 weeks

Study Arms (2)

SCH 900435

EXPERIMENTAL

Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.

Drug: SCH 900435

Placebo

PLACEBO COMPARATOR

Participants received matching placebo tablets by mouth twice daily for 12 weeks.

Drug: Placebo

Interventions

SCH 900435 DRUG

tablets

Also known as: Org 25935, MK-8435

SCH 900435

Placebo DRUG

tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• de Bejczy A, Nations KR, Szegedi A, Schoemaker J, Ruwe F, Soderpalm B. Efficacy and safety of the glycine transporter-1 inhibitor org 25935 for the prevention of relapse in alcohol-dependent patients: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2014 Sep;38(9):2427-35. doi: 10.1111/acer.12501.

  PMID: 25257291 RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

N-methyl-N-(6-methoxy-1-phenyl-1,2,3,4-tetrahydronaphthalen-2-ylmethyl)aminomethylcarboxylic acid

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: February 13, 2009
• Primary Completion: May 28, 2010
• Study Completion: July 8, 2010
• Last Updated: October 16, 2018
• Results First Posted: September 1, 2016

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share