Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York State Psychiatric Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

meet DSM-5 criteria for OUD

Voluntarily seeking buprenorphine treatment for OUD

Able to provide informed consent and comply with study procedures

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Buprenorphine SL

    Drug

    Up to 24 mg per day

  • Telehealth

    Other intervention

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

  • In-person treatment as usual

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Telehealth buprenorphine induction and maintenanceExperimental treatment 2 interventions
Group B: Standard in-person SL buprenorphine induction and maintenanceActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to drop out

Comparing time to drop out between the treatment arms

Time frame
12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York State Psychiatric Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: