Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

NCT ID: NCT05339256

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-12-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Buprenorphine SL

Intervention Type: DRUG

Up to 24 mg per day

Telehealth

Intervention Type: OTHER

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

Standard in-person SL buprenorphine induction and maintenance

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

Group Type: ACTIVE_COMPARATOR

Buprenorphine SL

Intervention Type: DRUG

Up to 24 mg per day

In-person treatment as usual

Intervention Type: OTHER

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

Interventions

Buprenorphine SL

Up to 24 mg per day

Intervention Type: DRUG

Telehealth

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

Intervention Type: OTHER

In-person treatment as usual

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Christina Ann Brezing

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Brezing, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Central Contacts

Christina Brezing, MD

Role: CONTACT

cb3108@columbia.edu

646-774-6132

Elizabeth Martinez

Role: CONTACT

646-774-8181

Other Identifiers

R21DA055835

Identifier Type: NIH

Identifier Source: secondary_id

View Link

8305

Identifier Type: -

Identifier Source: org_study_id