CTRI/2011/11/002154已完成3 期
Efficacy and safety of Baclofen GRS for treatment of alcohol dependence: A randomized, double blind, placebo controlled, comparative, parallel groups, multi-centric, 12-week study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects with age 21 to 75-years inclusive, meeting DSM-IV-TRï?ª criteria for current alcohol dependence (per appendix I: M.I.N.I. for alcohol abuse and dependence) who are detoxified before enrollment in study. (subjects who have completed detoxification treatment can be enrolled)
- •2.Presence of referred family member able to assist with drug administration and monitoring.
- •3.Express a desire to achieve abstinence or to greatly reduce alcohol consumption.
- •4.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
- •5.Willing to participate and give written informed consent.
排除标准
- •1.Requiring inpatient detoxification and treatment with drugs other than single agent baclofen.
- •2.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal.
- •3.Bilirubin more than the upper limit of normal.
- •4.Current treatment with naltrexone, disulfiram, acamprosate, topiramate, ondansetron: subjects can be included after appropriate washout.
- •5.Positive urine screen on amphetamines/ barbiturates/ benzodiazepines/ cocaine/ opiates.
- •6.Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., cirrhosis, kidney impairment, unstable hypertension, hypotension, diabetes mellitus, seizure disorder).
- •7.Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than alcohol or nicotine dependence. Subjects with ADHD/ ASPD may be included at discretion of the investigator.
- •8.Current episode marked by/ current presentation of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
- •9.Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics. Subjects who have been taking benzodiazepines for alcohol detoxification will be required to have a washout period of approximately 5 days from those medications before being randomized.
- •10.Participation in another clinical trial within the preceding 60 days of study start.
研究者
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