Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study
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
- 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
研究组 & 干预措施
intervention
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)
