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AlcoholismPhase 2OD-HNCT00764660

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

A Phase 2 study testing SCH 900435 in people with Alcoholism, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcoholism
What is being tested?
SCH 900435
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
141 participants
Where
No sites listed yet
Study dates
13 Feb 2009to 8 Jul 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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;
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  • 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.

About this study

Official title: A Prospective, Double-Blind, Placebo-Controlled Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Subjects With Alcohol Dependence.

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
Being tested
SCH 900435, Placebo
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCH 900435Drug

    Also called Org 25935, MK-8435

    tablets

  • PlaceboDrug

    tablets

Study groups in NCT00764660
Study groupRoleWhat they receive
SCH 900435ExperimentalParticipants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
Receives: Drug: SCH 900435
PlaceboPlacebo comparatorParticipants received matching placebo tablets by mouth twice daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (13)

  1. Number of Drinks Per Drinking Day

    The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with 'day' being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.

    Measured: 12 weeks

  2. Number of Relapses Into Heavy Drinking

    An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).

    Measured: 12 weeks

  3. Number of Lapses Into Any Drinking

    An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).

    Measured: 12 weeks

  4. Time to First Relapse Into Drinking

    Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.

    Measured: 12 weeks

  5. Percentage of Abstinent Days

    Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.

    Measured: 12 weeks

  6. Percentage of Participants With Complete Abstinence

    Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.

    Measured: 12 weeks

  7. Global Functioning: Clinical Global Impression (CGI) - Severity of Illness

    The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.

    Measured: Day 84

  8. Global Functioning: CGI - Therapeutic Effect

    The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.

    Measured: Day 84

  9. Change From Baseline in Craving Visual Analog Scale (VAS) Score

    Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: "Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?" The 100 mm line of the VAS was anchored on the left by "No desire at all" and on the right by "Extreme desire". Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome.

    Measured: Baseline and Day 84

  10. Change From Baseline in Motivation VAS Score

    Participants were asked to answer the question: "Over the past week, how motivated were you to stay alcohol abstinent?" The 100 mm line of the VAS was anchored on the left by "No motivation at all" and on the right by "Extremely motivated". Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome.

    Measured: Baseline and Day 84

  11. Change From Baseline in Mood VAS Score

    Participants were asked to answer the question: "Over the past week, how did you feel?" The 100 mm line of the VAS was anchored on the left by "Extremely bad" and on the right by "Extremely good". Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome.

    Measured: Baseline and Day 84

  12. Number of Participants Who Experienced an Adverse Event (AE)

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.

    Measured: Up to 16 weeks

  13. Number of Participants Who Discontinued Study Drug Due to an AE

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2008 (estimated)
  2. Study start13 Feb 2009
  3. Primary completion28 May 2010
  4. Study completion8 Jul 2010

Why it stopped: Based on the outcome of a planned interim analysis, the study was stopped early due to futility.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00764660
Sponsor's protocol ID
P05718
Other IDs
2008-005318-35, 172009, MK-8435-003, 2008
Acronym
OD-H
Status last verified
Sep 2018
First submitted
30 Sep 2008
Last updated
16 Oct 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 25257291

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCH 900435 in people with Alcoholism, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Heavy Drinking Days (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00764660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.

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