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临床试验/NCT00238914
NCT00238914已完成2 期

Opiate Dependence: Combined Naltrexone/Behavior Therapy

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 1999年8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
12
试验地点
1
主要终点
Relapse to heroin addiction

研究概览

简要总结

The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES:

  1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy.
  2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.

详细描述

Long-term maintenance on naltrexone has proven efficacy as a treatment for opiate dependence, but has not been successful clinically because of at least three problems: 1) The transition from opiate to naltrexone precipitates opiate withdrawal unless the patient has been off any opiates for at least seven days; 2) Compliance issues: patients can miss a few naltrexone doses and begin to experience effects from illicit opiates and become re-addicted, at which point naltrexone cannot be restarted without precipitating withdrawal; 3) Naltrexone may produce dysphoria in some patients. The proposed research study will offer opiate dependent patients brief hospitalization for a rapid detoxification from opiate to naltrexone, using buprenorphine, clonidine and clonazepam. If the patient has already undergone detoxification at an outside unit, they will be assessed for opiate dependence using the naloxone challenge. Patients will then be either discharged or entered directly into outpatient treatment where they will be randomly assigned to either the newly developed "Behavioral Naltrexone Therapy" (BNT), a hybrid of Relapse Prevention, the Community Reinforcement Approach, and Network Therapy or to Compliance Enhancement (CE) therapy, a controlled therapy intended to simulate outpatient psychiatric care. BNT employs behavioral incentives and enlists members of the family and social network to reinforce naltrexone compliance and abstinence. In this current investigation, for both BNT and CE, all patients are maintained on oral naltrexone. Patients are stratified at baseline by presence or absence of lifetime depressive disorder, which the investigators hypothesize will predict dysphoria on naltrexone and non-compliance. Patients are discharged from the hospital, or entered directly, into outpatient treatment at STARS at NYSPI to receive both counseling and Naltrexone, 50 mg per day.

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
None

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

CE plus oral naltrexone

Active Comparator

Compliance enhancement plus oral naltrexone

干预措施: Naltrexone (Drug)

CE plus oral naltrexone

Active Comparator

Compliance enhancement plus oral naltrexone

干预措施: Compliance Enhancement (CE) (Behavioral)

BNT plus oral naltrexone

Active Comparator

Behavioral naltrexone therapy plus oral naltrexone

干预措施: Naltrexone (Drug)

BNT plus oral naltrexone

Active Comparator

Behavioral naltrexone therapy plus oral naltrexone

干预措施: Behavioral Naltrexone Therapy (BNT) (Behavioral)

结局指标

主要结局

Relapse to heroin addiction

时间窗: Up to 24 weeks or length of study participation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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