NCT05339256

Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).

Detailed description

The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine SL	Up to 24 mg per day
OTHER	Telehealth	Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
OTHER	In-person treatment as usual	in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-04-21
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study