EUCTR2008-005318-35-NL进行中（未招募）不适用
A prospective, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 25935 in relapse prevention in subjects with alcohol dependence. - OH-D
V Organon0 个研究点目标入组 300 人开始时间: 2009年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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;
- •15. A clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration, glaucoma or retinal disease;
- •16. 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;
- •17. 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;
- •18. QTc interval (Fridericia corrected) at screening >450 ms (male), >470 ms (female);
- •19. 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;
- •20. History or present evidence of epileptic disorders or withdrawal seizures;
- •21. History of substance withdrawal delirium;
- •22. 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);
- •23. Pending legal charges with the potential for incarceration, probation, or parole;
- •24. Homelessness (less than 2 months stable residence);
- •25. Participation in a clinical trial during the three months prior to screening.
研究者
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