A prospective, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 25935 in relapse prevention in subjects with alcohol dependence

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

•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;
•BMI > 16 kg/m^2;
•Breath alcohol concentration < 0.02% (at screening and baseline)
•Male or female (not of childbearing potential, or not pregnant, non-lactating and using adequate contraception)

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Percentage of days of relapse into heavy drinking</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Number of drinks per heavy drinking day<br /><br>• Number of drinks per drinking day<br /><br>• Percent of abstinent days<br /><br>• Percent of complete abstinence<br /><br>• Number of relapses<br /><br>• Number of lapses<br /><br>• Cumulative number of no or non-heavy drinking days<br /><br>• Time to first relapse into heavy drinking<br /><br>• Time to first drink<br /><br>• Obsessive Compulsive Drinking Scale<br /><br>• Visual Analogue scale<br /><br>• Clinical Global Impression<br /><br>• Number of responders<br /><br>• Alcohol marker</p><br>

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