Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 主要终点
- Proportion of positive urine tests for by-consumption of target substances per subject
研究概览
简要总结
To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone
详细描述
The objective of this study is to compare the effectiveness of slow-release oral morphine (SROM) treatment in patients that previously have been treated with methadone. Efficacy is assessed by the frequency of by-consumption of illicit substances. The primary efficacy endpoint in this study is the proportion of positive urine tests for by-consumption of target substances per subject. Target substances are defined as all opioids except the study drug.
The proportions are compared between substitution with methadone and SROM treatment in a crossover design.
The secondary endpoints are:
- The effects of SROM on retention rate.
- By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines).
- Occurring psychopathological and somatic symptoms.
- Effect of treatment on the ECG (QTc prolongation).
- Group characterisation of patients that is keen to change the medication.
- The change in dosage of treatment over time.
- Self-assessed craving for Opioids.
- Self-assessed satisfaction with treatment.
- Nature, frequency and severity of occurring adverse events in the two treatment groups.
- Assessment of safety parameters.
Study Design (Methodology):
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sevre-Long™
slow release oral morphine
干预措施: Sevre-Long™ (Drug)
Sevre-Long™
slow release oral morphine
干预措施: Slow release oral morphine (Drug)
Methadone
Methodone
干预措施: Methadone (Drug)
结局指标
主要结局
Proportion of positive urine tests for by-consumption of target substances per subject
时间窗: each week during the 22 week cross-over phase
The primary efficacy endpoint in this study is the proportion of positive urine tests for by-consumption of target substances per subject. Target substances are defined as all opioids except the study drug. The proportions are compared between substitution with methadone and SROM treatment in a crossover design.
次要结局
- Secondary Outcome Measures(throughout the 22 week cross over period)
- By-consumption of other drugs (cocaine, alcohol, cannabis, benzodiazepines)(throughout the 22 week cross over period)
- Occurring psychopathological and somatic symptoms.(througout the 22 week cross over period)
- Effect of treatment on the ECG (QTc prolongation)(throughout the 22 week cross over phase)
- Group characterisation of patients that is keen to change the medication(throughout the 22 week cross over period)
- The change in dosage of treatment over time(throughout the 22 week cross over period)
- Self-assessed craving for Opioids(throughout the 22 week cross over period)
- Self-assessed satisfaction with treatment.(throughout the 22 week cross over period)
- Nature, frequency and severity of occurring adverse events in the two treatment groups(throughout the 22 week cross over period)
- Assessment of safety parameters(throughout the 22 week cross over period)