Efficacy of transdermal v/s sublingual Buprenorphine in management of Opioid Detoxification : An open labelled Randomised Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification period
研究概览
简要总结
This study is an open-label, randomized, parallel group trial to compare the efficacy of transdermal buprenorphine patch v/s sublingual buprenorphine tablets in the management of opioid detoxification in 60 patients with ICD-10 diagnosis of F11.3 Mental and behavioral disorders due to use of opioids, withdrawal state that will be conducted in Kalinga Institute of Medical Sciences, Bhubaneswar and in some deaddiction/rehabilitation centers in and around Bhubaneswar. The primary outcome measures will be daily assessment of reduction in Clinical Opiate Withdrawal Scale scores in both groups over 7 days. The secondary outcome measures will be daily assessment of reduction in Subjective Opiate Withdrawal Scale scores, daily assessment of adverse drug reactions of buprenorphine and requirement of additional medications in both groups over 7 days.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females with ICD-10 diagnosis of F12.3 i.e. Mental and Behavioral disorders due to use of opioids.
- •Withdrawal state, admitted in the inpatient department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, and admitted in deaddiction centres in and around Bhubaneswar, who have given written consent for participation in the study.
排除标准
- •Patients opting for non-opioid based detoxification.
- •Patients with debilitating medical illness where buprenorphine cannot be used Patients with coexisting other substance use in dependent pattern(except Nicotine dependence).
结局指标
主要结局
Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification period
时间窗: Reduction in Clinical Opiate Withdrawal Scale (COWS) scores over 7 days of detoxification period
次要结局
- a)Reduction in Subjective Opiate Withdrawal Scale (SOWS) score(b)Monitoring of adverse drug reactions of Buprenorphine)
研究者
Titas Chaudhuri
Kalinga Institute of Medical Sciences, Bhubaneswar