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Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Primary Purpose

Opioid Use Disorder

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Buprenorphine SL

Telehealth

In-person treatment as usual

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehealth buprenorphine induction and maintenance

Standard in-person SL buprenorphine induction and maintenance

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to drop out

Comparing time to drop out between the treatment arms

Secondary Outcome Measures

Full Information

NCT ID

NCT05339256

First Posted

April 14, 2022

Last Updated

August 29, 2023

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05339256

Brief Title

Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

randomized, active-control, open-label

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telehealth buprenorphine induction and maintenance

Arm Type

Experimental

Arm Description

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

Arm Title

Standard in-person SL buprenorphine induction and maintenance

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Buprenorphine SL

Intervention Description

Up to 24 mg per day

Intervention Type

Other

Intervention Name(s)

Telehealth

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

In-person treatment as usual

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to drop out

Description

Comparing time to drop out between the treatment arms

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christina Brezing, MD

Phone

646-774-6132

cb3108@columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Martinez

Phone

646-774-8181

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Brezing, MD

Organizational Affiliation

New York State Psychiatric Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)

IPD Sharing Time Frame

beginning twelve months and ending 5 years after article publication

IPD Sharing Access Criteria

to researcher who provides a methodologically sound proposal to achieve aims in approved proposal

Learn more about this trial

Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

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