Evaluation of NMDA Antagonist for Opiate Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Retention in Treatment
研究概览
简要总结
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.
详细描述
The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone.
This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo plus oral naltrexone
干预措施: Naltrexone (Drug)
Memantine 30 mg bid
Memantine 30 mg bid plus oral naltrexone
干预措施: Memantine (Drug)
Memantine 30 mg bid
Memantine 30 mg bid plus oral naltrexone
干预措施: Naltrexone (Drug)
Memantine 15 mg bid
memantine 15 mg bid plus oral naltrexone
干预措施: Memantine (Drug)
Memantine 15 mg bid
memantine 15 mg bid plus oral naltrexone
干预措施: Naltrexone (Drug)
结局指标
主要结局
Retention in Treatment
时间窗: Number of participants who complete 12 weeks of treatment
The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.
次要结局
未报告次要终点
研究者
Adam Bisaga
Research Psychiatrist
New York State Psychiatric Institute
