Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report
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 in the naltrexone experimental group are prematched in a pairwise fashion with other patients who do not want a naltrexone implant during the first six months after ending inpatient treatment, but who reiceive treatment as usual (TAU) from the Norwegian healthcare system.
The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up.
We 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
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
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
结局指标
主要结局
Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report
次要结局
- Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI