Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

NCT05339256 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 8305R21DA055835
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Time to drop out

  Comparing time to drop out between the treatment arms

  12 weeks

Study Arms (2)

Telehealth buprenorphine induction and maintenance

EXPERIMENTAL

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; Other: Telehealth

Standard in-person SL buprenorphine induction and maintenance

ACTIVE COMPARATOR

In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Drug: Buprenorphine SL; Other: In-person treatment as usual

Interventions

Buprenorphine SL DRUG

Up to 24 mg per day

Standard in-person SL buprenorphine induction and maintenance; Telehealth buprenorphine induction and maintenance

Telehealth OTHER

Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session

Telehealth buprenorphine induction and maintenance

In-person treatment as usual OTHER

in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Standard in-person SL buprenorphine induction and maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Christina Brezing, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Brezing, MD

CONTACT

646-774-6132; cb3108@columbia.edu

Elizabeth Martinez

CONTACT

646-774-8181

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: randomized, active-control, open-label

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning twelve months and ending 5 years after article publication
• Access Criteria: to researcher who provides a methodologically sound proposal to achieve aims in approved proposal