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
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder
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.
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
No
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
No
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
Email
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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