FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
Close