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临床试验/CTRI/2025/12/099064
CTRI/2025/12/099064尚未招募不适用

Comparison of Buprenorphine Tapering Schedule for Withdrawal Management Among Outpatients Dependent on Natural Opioids: A Prospective, Open-Label, Parallel-Group Randomised Controlled Trial

All India Institute Of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
试验地点
1

研究概览

简要总结

The purpose of this study is to primarily assess the differences in opioid abstinence and treatment adherence between two Buprenorphine based outpatient detoxification programs in clients diagnosed with both opioid dependence and opioid withdrawal according to ICD 11.  In this study, we will directly compare 2 weeks versus 4 weeks Buprenorphine tapering schedules in terms of effectiveness for withdrawal management among natural opioid dependent individuals in an outpatient setting. A critical issue in outpatient buprenorphine use is the lack of consensus on optimal tapering duration. Buprenorphine is extensively used for managing opioid withdrawal; most existing research is derived from inpatient/controlled settings, focused on heroin or prescription opioid users, and primarily conducted in Western countries. There is a significant gap in the evidence base regarding the optimal duration of buprenorphine taper for natural opioid users in India. This study proposes to determine whether a longer taper duration improves abstinence rates compared to a shorter one in real world outpatient settings. Therefore, identifying the most effective and tolerable tapering duration, especially with respect to parameters such as abstinence, craving, and patient satisfaction, is highly important and may add to the existing literature.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients using natural opioids and having Opioid dependence according to ICD-
  • Patient choosing withdrawal management followed by long-term antagonist management.
  • Able to understand Hindi or English.
  • Those who consented and are willing to attend outpatient follow-ups for the study period.

排除标准

  • Patients opting for Opioid Substitution Therapy.
  • Patients who are consuming opioids other than natural opioids.
  • Patients who will require more than 8mg of Buprenorphine to manage withdrawal.
  • Patients with other substance dependence excluding tobacco.
  • Patients with comorbid psychiatric illness.
  • Patients with any chronic medical or surgical comorbidity.
  • Patient having other pain causing illnesses.

研究者

发起方
All India Institute Of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ishwar Tiwari

All India Institute of Medical Sciences

研究点 (1)

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