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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Drug: Buprenorphine SL; Other: Telehealth; Other: In-person treatment as usual

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christina Brezing, MD; Phone Number: 646-774-6132; Email: cb3108@columbia.edu
• Study Contact Backup: Name: Elizabeth Martinez; Phone Number: 646-774-8181

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• meet DSM-5 criteria for OUD
• Voluntarily seeking buprenorphine treatment for OUD
• Able to provide informed consent and comply with study procedures

Exclusion Criteria:

• Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification
• Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder
• Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
• Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
• Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
• Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation
• Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide
• Legally mandated to substance use disorder treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telehealth buprenorphine induction and maintenance; Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine	Drug: Buprenorphine SL; Up to 24 mg per day; Other: Telehealth; Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
Active Comparator: Standard in-person SL buprenorphine induction and maintenance; In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.	Drug: Buprenorphine SL; Up to 24 mg per day; Other: In-person treatment as usual; in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to drop out	Comparing time to drop out between the treatment arms	12 weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Christina Brezing, MD, New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Health Services Administration; Delivery of Health Care; Patient Care Management; Telemedicine
• Other Study ID Numbers: 8305 (CTEP); R21DA055835 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
• IPD Sharing Time Frame: beginning twelve months and ending 5 years after article publication
• IPD Sharing Access Criteria: to researcher who provides a methodologically sound proposal to achieve aims in approved proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No