Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Data From a Real Life Scenario.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 384
- 主要终点
- Retention Rate After 12 Months of Treatment With Suboxone
研究概览
简要总结
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.
详细描述
Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.
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
- •Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.
排除标准
- •In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.
研究组 & 干预措施
Suboxone
Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
干预措施: Buprenorphine/Naloxone (Drug)
结局指标
主要结局
Retention Rate After 12 Months of Treatment With Suboxone
时间窗: 12 months
The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.
次要结局
- Dosage of SUBOXONE®(Day 1 and Final Assessment (month 12 or time of dropout))
- Take Home Prescriptions of SUBOXONE®(Day 1 and Final Assessment (month 12 or time of dropout))
- Drug Craving (Subjective Effects of Therapy)(Baseline and Final Assessment (month 12 or time of dropout))