Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Abstinent time of Methamphetamine addict
研究概览
简要总结
Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among methamphetamine addicts.
详细描述
Methods:A Multiple-Center, Randomized, Double-Blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years to 60 years
- •Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
- •Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
- •Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
- •Participants were interesting in reducing or stopping METH use
- •Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
- •Women of childbearing potential agreed to use contraception during the study.
- •Exclusion criteria:
- •Pregnancy or breastfeeding;
- •Significant medical conditions (eg., acute renal failure, endocarditis, and tuberculosis); hepatic failure; past or present history of an AIDS-indicator disease; active hepatitis or aspartate amino transferase or alanine aminotransferase more than three times the upper limit of normal
- •Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.
排除标准
- 未提供
研究组 & 干预措施
paliperidone
paliperidone arm,3mg/pill,3mg/day.last84 days.
干预措施: Paliperidone (Drug)
placebo
placebo group,3mg/pill,3mg/day non-forced titration method,last84 days.
干预措施: placebo (Drug)
结局指标
主要结局
Abstinent time of Methamphetamine addict
时间窗: up to 84 days
The outcome was the confirmed abstinence during 12 weeks. Confirmed abstinence was defined as a negative urine drug test. The following aggregate measures of urine drug test results were calculated: the time-to-first positive urine test, the Treatment Effectiveness Score (TES; the sum of the number of METH-free urine samples submitted per participant ), the longest period of MA abstinence during the 84 days.
次要结局
- number of treatment day which calculated from randomization to the last visiting point(up to 84 days)
- Change from baseline in Visual Analogue Scale (VAS) at 84 days(up to 84 days)
- Change from baseline in CGI-S scores at 84 days(up to 84 days)
- Time (day) to first psychosis relapse from baseline to 84 days(up to 84 days)
研究者
Wei Hao
The Second Xiangya Hospital of Cental South University
Central South University