Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

New York State Psychiatric Institute

Status and phase: Not yet enrolling; Phase 2

Conditions: Opioid Use Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05339256

R21DA055835 (U.S. NIH Grant/Contract)

8305 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Telehealth buprenorphine induction and maintenance

Experimental group

Description:

Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine

Treatment:

Drug: Buprenorphine SL

Other: Telehealth

Standard in-person SL buprenorphine induction and maintenance

Active Comparator group

Description:

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

Treatment:

Drug: Buprenorphine SL

Other: In-person treatment as usual