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临床试验/NCT00521157
NCT00521157已完成2 期

Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study

University of Oslo1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006年1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
56
试验地点
1
主要终点
Drug use at 6 (12) months by self report and hair analysis

研究概览

简要总结

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.

The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.

The investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • soon to complete inpatient treatment for opioid addiction
  • living in southern Norway

排除标准

  • psychosis/major depression, currently not treated
  • pregnancy
  • liver enzymes: ASAT or ALAT > threefold above upper boundary
  • maintenance treatment with methadone or buprenorphine

研究组 & 干预措施

intervention

Experimental

Experimental group randomised after abstinence oriented treatment

干预措施: Go Medical Naltrexone implants (Drug)

结局指标

主要结局

Drug use at 6 (12) months by self report and hair analysis

时间窗: 6 and 12 months

Days in work or education

时间窗: 6 and 12 months

Number of drug-free friends at 6 (12) months by self report

时间窗: 6 and 12 months

次要结局

  • Depression at 6 (12) months by BDI and Hopkins SCL-25(6 and 12 months)
  • Quality of life at 6 (12) months by EuropASI(6 and 12 months)

研究者

申办方类型
Other

研究点 (1)

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