Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: Buprenorphine SL
* Other: Telehealth
* Other: In-person treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, active-control, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth buprenorphine induction and maintenance<br>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<br>* Up to 24 mg per day<br>Other: Telehealth<br>* Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session<br>|
| Active Comparator: Standard in-person SL buprenorphine induction and maintenance<br>In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual. | Drug: Buprenorphine SL<br>* Up to 24 mg per day<br>Other: In-person treatment as usual<br>* in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.<br>|

What is the study measuring?
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Primary Outcome Measures

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