Telemedicine-assisted buprenorphine induction versus standard of care: A randomized controlled non-inferiority trial

Addiction. 2025 Nov 30. doi: 10.1111/add.70269. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Although buprenorphine-based opioid agonist maintenance treatment (OAMT) is effective, logistical, economic and stigma-related barriers limit access. Telemedicine-Assisted Buprenorphine Induction (TABI) may address these barriers. This study evaluated the non-inferiority of TABI compared with the Standard of Care (SoC) for buprenorphine induction.

DESIGN: Open-label, two-arm, randomized controlled non-inferiority trial. The induction period lasted 7 days, after which all participants continued buprenorphine-based OAMT as routine care. Follow-up assessments were done at one week and one month.

SETTINGS: Addiction treatment center, Chandigarh, India.

PARTICIPANTS: Adults with opioid use disorder (OUD) meeting ICD-11 (International Classification of Diseases, 11th Revision) criteria, recruited between December 2023 and August 2024. A total of 138 participants were randomized (SoC = 70; TABI = 68). The mean age of participants was 28.2 years. Most participants were male (98.55%).

INTERVENTION: SoC involved supervised in-person buprenorphine induction for three days. TABI consisted of in-person induction on Day 1, followed by telemedicine-based follow-ups for Days 2-6. In-person review on Day 7 in both arms.

MEASUREMENTS: Primary outcome: treatment retention at one week, using a 15% non-inferiority margin.

SECONDARY OUTCOMES: abstinence from illicit opioids, withdrawal symptoms, cravings, quality of life, satisfaction, therapeutic alliance and medication adherence.

FINDINGS: The one-week retention rate was 75.71% in the SoC group and 82.35% in the TABI group, with an absolute difference of 6.64% [95% confidence interval (CI) = -6.88% to 20.16%]. The lower limit of the 95% confidence interval for the difference (-6.88%) is above the pre-specified non-inferiority margin, confirming the non-inferiority of TABI compared with SoC. Both groups showed statistically significant improvements in withdrawal symptoms, cravings and quality of life over time, with no statistically significant group differences. Patient satisfaction, therapeutic relationships, adherence and side effects were comparable between groups.

CONCLUSION: This randomized controlled trial found that telemedicine-assisted buprenorphine induction was non-inferior to standard care for one-week retention in treatment among adults with opioid use disorder. As such, it offers a patient-centred alternative to standard care and has the potential to reduce treatment barriers and improve access in resource-limited settings.

PMID:41320172 | DOI:10.1111/add.70269