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: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Provide written informed consent after the scope and nature of the investigation, have been explained to the subject before screening; 2. 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); 3. Primary complaints according to Mini-International Neuropsychiatric Interview (MINI) should be alcohol problems; 4. 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; 5. Age 18-65 years at screening; 6. 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; 7. BMI > 16 kg/m2; 8. Breath alcohol concentration < 0.02% (at screening and at baseline).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

9. Subjects requiring pharmacological treatment for a primary diagnosis of major depressive disorder, anxiety, panic disorder or social phobia; 10. Subjects with psychotic disorders (according to MINI); 11. Subjects with a medium or high suicidality risk (as assessed by MINI); 12. 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; 13. Use of one of the following drugs during the last 14 days prior to screening: cannabis, amphetamines, opiates, cocaine, hallucinogens; 14. 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects of Org 25935 on heavy drinking in subjects with alcohol dependence;Secondary Objective: To assess the effects of Org 25935 on the amount of drinking To assess the effects of Org 25935 on the first relapse to heavy drinking To assess the effects of Org 25935 on abstinence To assess the safety and tolerability of Org 25935 To explore potential predictors of response to Org 25935;Primary end point(s): Percentage of heavy drinking days, defined as days with &#8805; 5 standard drinks for men and &#8805; 4 standard drinks for women (assessed by timeline follow back method (TLFB))

Secondary Outcome Measures

Name	Time	Method

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