Evaluation of Transfer From Subutex or Other Treatment for Opioid Drug Dependence to Suboxone: Acceptability, Safety and Impact on Medication Dispensing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing. Subjects, for whom a therapy with Suboxone® is indicated and planned prior to study enrollment and who are willing to participate, will initiate therapy on Day 1 of the study. The dosage will be adjusted between Day 2 to 7 depending on patient's needs and determined by the treating physicians in accordance with the SmPC of Suboxone®. Data will be collected at baseline, day 1 til 7, the end of weeks 2 and 4 and monthly up to the end of Month 12.
详细描述
Nonprobability sampling was done by invitation to volunteer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients on substitution therapy, that are willing to switch to Suboxone, can be included.
- •Therapeutic indications and contraindications for Suboxone® must be taken into consideration when selecting patients.
排除标准
- •According to product information
- •In accordance with the product information pregnant women will be excluded.
研究组 & 干预措施
Patients
Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
干预措施: buprenorphine/naloxone (Drug)
结局指标
主要结局
Retention Rate
时间窗: month 6, month 12
The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study
次要结局
- Dispensing of Suboxone (Buprenorphine Plus Naloxone)(month 6, month 12)
- Dosing of Suboxone (Buprenorphine Plus Naloxone)(day 1, month 6, month 12)