An Open-Label trial assessing acceptability of Buprenorphine sublingual films
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Retention in treatment at 4 weeks
研究概览
简要总结
This is an open label, prospective, randomized, study to assess acceptability of Buprenorphine sublingual films 8/6/4 mg in adult opioid dependence patients and in healthcare providers. Subjects with opioid dependence who meet all the eligibility criteria, based on medical history and clinical examination will be recruited in this study. After written informed consent, patients will be randomized to either of the two treatment arms: intervention arm i.e. Buprenorphine sublingual films or comparator arm i.e. continued treatment with Buprenorphine sublingual tablets, which represents treatment as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Adult male meeting criteria for opioid dependence as defined by the International Statistical Classification of Diseases and Related Health Problems eleventh edition who are an appropriate candidate for Opioid Agonist Maintenance Treatment with buprenorphine on a daily dispensing schedule and stabilized on a constant dose between 4 mg to 18 mg per day for a minimum period of one week and willing to remain on buprenorphine during the phase of the trial.
排除标准
- •Any known allergy, hypersensitivity or intolerance to BPN or NX or any related drug, or history of any drug hypersensitivity or intolerance which in the opinion of the Investigator, would compromise the safety of the patient or the trial.
- •Patients with serious oral lesions/pathology which makes sublingual film administration difficult.
结局指标
主要结局
Retention in treatment at 4 weeks
时间窗: weekly visit upto 4 weeks
Negative urine drug screening for opioids at 4 weeks
时间窗: weekly visit upto 4 weeks
• Subjective dose effects of buprenorphine films (craving, withdrawal, drug liking) (Weekly)
时间窗: weekly visit upto 4 weeks
次要结局
- Self-reported abstinence (Weekly)(Side effects & Adverse events (AEs) (Weekly))
研究者
Atul Ambekar
All India Institute of Medical Sciences DELHI