| CTRI Number |
CTRI/2025/12/099064 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Buprenorphine Tapering Schedule for Withdrawal Management Among Outpatients Dependent On Natural Opioids |
|
Scientific Title of Study
|
Comparison of Buprenorphine Tapering Schedule for Withdrawal Management Among Outpatients Dependent on Natural Opioids: A Prospective, Open-Label, Parallel-Group Randomised Controlled Trial |
| Trial Acronym |
BWIN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishwar Tiwari |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
1C, Department of Psychiatry, All India Institute of Medical Sciences, Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
9687795755 |
| Fax |
|
| Email |
ishwart14@gmai.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Navratan Suthar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Psychiatry, All India Institute of Medical Sciences, Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
7820980262 |
| Fax |
|
| Email |
navratansuthar86@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ishwar Tiwari |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
1C, Department of Psychiatry, All India Institute of Medical Sciences, Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
9687795755 |
| Fax |
|
| Email |
ishwart14@gmai.com |
|
|
Source of Monetary or Material Support
|
| Research Section, 6th Floor, AIIMS, Jodhpur, Basni, Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Accounts Department AIIMS Jodhpur |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishwar Tiwari |
All India Institute of Medical Sciences |
Department of Psychiatry, All India Institute Of Medical Sciences, Jodhpur Jodhpur RAJASTHAN |
9687795755
ishwart14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Clinical Trials) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention with Sublingual Tablet in both treatment arms. |
Buprenorphine is the standard treatment modality for opioid induced withdrawal. Selection criteria mandates dosage upto 8mg per day. Associated risk are clearly stated in the Participant Information Sheet. |
| Comparator Agent |
Sublingual Tablet Buprenorphine |
Same as mentioned in Intervention section. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients using natural opioids and having Opioid dependence according to ICD-11. 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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The 4-week taper group is hypothesized to show better
opioid abstinence and higher treatment adherence post-taper compared to the 2-week
group. |
Measured at end of 5 weeks in both treatment arms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improved treatment retention as measured by intention-to-treat (the number of
participants still in treatment at the end of the study) |
in 5 weeks |
| Greater patient satisfaction post-treatment in longer taper group |
At end of 3 & 5 week in respective arms |
| Differences in relapse rates or self-reported substance use between group |
At end of study, in 5 week in both arms |
| Lower need for adjuvant medications in the 4 week group |
At end of the study post 5 weeks |
| Reduced craving as measured by TSQM tool |
At end of 3 & 5 week in respective arms |
|
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |