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临床试验/NCT00125515
NCT00125515已完成2 期

Evaluation of NMDA Antagonist for Opiate Dependence

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2005年6月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo plus oral naltrexone

干预措施: Naltrexone (Drug)

Memantine 30 mg bid

Active Comparator

Memantine 30 mg bid plus oral naltrexone

干预措施: Memantine (Drug)

Memantine 30 mg bid

Active Comparator

Memantine 30 mg bid plus oral naltrexone

干预措施: Naltrexone (Drug)

Memantine 15 mg bid

Active Comparator

memantine 15 mg bid plus oral naltrexone

干预措施: Memantine (Drug)

Memantine 15 mg bid

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Bisaga

Research Psychiatrist

New York State Psychiatric Institute

研究点 (1)

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