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Comparison of Buprenorphine Tapering Schedule for Withdrawal Management Among Outpatients Dependent On Natural Opioids

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099064
Enrollment
102
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: Intervention with Sublingual Tablet in both treatment arms.: Buprenorphine is the standard treatment modality for opioid induced withdrawal. Selection criteria mandates dosage upto 8mg

Sponsors

All India Institute Of Medical Sciences Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The 4-week taper group is hypothesized to show better opioid abstinence and higher treatment adherence post-taper compared to the 2-week group.Timepoint: Measured at end of 5 weeks in both treatment arms

Secondary

MeasureTime frame
Improved treatment retention as measured by intention-to-treat (the number of participants still in treatment at the end of the study)Timepoint: in 5 weeks;Greater patient satisfaction post-treatment in longer taper groupTimepoint: At end of 3 & 5 week in respective arms;Differences in relapse rates or self-reported substance use between groupTimepoint: At end of study, in 5 week in both arms;Lower need for adjuvant medications in the 4 week groupTimepoint: At end of the study post 5 weeks;Reduced craving as measured by TSQM toolTimepoint: At end of 3 & 5 week in respective arms

Countries

India

Contacts

Public ContactIshwar Tiwari

All India Institute of Medical Sciences

navratansuthar86@gmail.com7820980262

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026