The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
研究概览
简要总结
The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment.
Study hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •opioid dependence
- •methadone treatment
- •no changes in methadone dose during the last 10 days
- •good treatment compliance according to doctor
- •normal ALAT and AFOS values (increased if double the normal level)
排除标准
- •severe renal or hepatic failure
- •acute psychosis
- •age under 18
- •pregnancy
- •legal incompetence
- •severe somatic disease
- •chaotic situation in life
- •medication or disease which is contraindication to study treatment
研究组 & 干预措施
Methadone naloxone combination product 2/0,04 mg/ml
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
干预措施: Methadone, naloxone (Drug)
Methadone 2 mg/ml
Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
干预措施: Methadone, naloxone (Drug)
结局指标
主要结局
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
时间窗: 1/2 hours after the first intake of medicine every week
COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).
次要结局
- The effectiveness of treatment (Treatment Outcomes Profile TOP)(Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.)
研究者
Ulrich Tacke
MD, PhD, docent
Kuopio University Hospital