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临床试验/NCT00135759
NCT00135759已完成2 期

Place of Low-Dose Naltrexone in Opiate Detoxification

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2005年4月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
174
试验地点
1
主要终点
Withdrawal intensity

研究概览

简要总结

There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.

详细描述

Although many different techniques for opiate detoxification exist, the search continues for more effective approaches to reduce the duration and discomfort associated with opioid withdrawal. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties. The purpose of this study is to investigate the effects of very low doses of naltrexone administered during a methadone tapering schedule for opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.

Participants in this double-blind study will be recruited among opioid dependent individuals already enrolled in a 6-day inpatient opioid detoxification program. Participants will be already receiving standard treatment to control discomfort during a methadone tapering schedule. Participants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for opiate addiction severity. They will continue to be evaluated daily for signs of withdrawal and salivary cortisol. An additional evaluation and urine test will be completed 1 day following discharge. Daily evaluations will take 15 minutes to complete. Seven days following discharge, participants will be contacted for a 20-minute phone interview. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse.

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, Outcomes Assessor)

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

入选标准

  • Current DSM-IV diagnosis of opiate dependence
  • Reads and understands English

排除标准

  • Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active hepatitis, kidney failure, uncontrolled diabetes)
  • Psychiatric conditions that require intensive services (e.g., depression with suicidal ideation, psychosis)
  • Mental retardation or other disorder that might limit ability to give informed consent

研究组 & 干预措施

Group 1

Placebo Comparator

Drug

干预措施: Placebo comparator (Drug)

2

Experimental

experimental

干预措施: naltrexone (Drug)

3

Experimental

experimental

干预措施: naltrexone (Drug)

结局指标

主要结局

Withdrawal intensity

时间窗: 6 days

次要结局

  • Retention in treatment(6 days)

研究者

申办方类型
Nih

研究点 (1)

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