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Telehealth Treatment for Opioid Use Disorders

Primary Purpose

Opioid Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OUD Telehealth Platform
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Harm Reduction, Medication for Opioid Use Disorder

Eligibility Criteria

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

Inclusion Criteria: Can speak, read and write in English Provision of signed and dated informed consent form Have a history of at least one opioid overdose Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer) OR be willing to use a device provided by the study team Can provide a working email address OR be willing to create one Exclusion Criteria: Current use of buprenorphine, methadone, or naltrexone for a substance use disorder Pregnancy or lactation Known current suicide risk based on participant self-report On parole or incarcerated at time of enrollment based on participant self-report

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    OUD Telehealth Platform

    Arm Description

    Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff.

    Outcomes

    Primary Outcome Measures

    Attendance for MOUD
    Overall attendance will be measured by attendance (yes or no) at the first buprenorphine appointment within 30 days of referral.

    Secondary Outcome Measures

    Engagement with MOUD
    Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of referral.
    Overdose Events at 30 Days
    A self-report of the number of subsequent overdose events at 30 days.
    Overdose Events at 90 Days
    A self-report of the number of subsequent overdose events at 90 days.

    Full Information

    First Posted
    April 14, 2023
    Last Updated
    August 7, 2023
    Sponsor
    Yale University
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05832879
    Brief Title
    Telehealth Treatment for Opioid Use Disorders
    Official Title
    A Pilot Study of Telehealth Treatment for Opioid Use Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first responders/providers and participants.
    Detailed Description
    The primary objective of the study is to assess effects of enrollment in a comprehensive telehealth platform, in adults with moderate or severe opioid use disorder with a history of at least one opioid overdose. Thirty adults with moderate or severe opioid use disorder with a history of at least one opioid overdose will be enrolled and the primary endpoint will be attendance at first appointment for medication for opioid use disorder at 30 days. Secondary aims include assessing engagement in the first MOUD appointment at 90 days and self-report of the number of subsequent overdose events at 30 and 90 days. Exploratory aims include feasibility of intervention, readiness and intention to engage in treatment, acceptability and satisfaction of intervention, and comparison of MOUD engagement with data from previous in-person studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorder
    Keywords
    Harm Reduction, Medication for Opioid Use Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OUD Telehealth Platform
    Arm Type
    Experimental
    Arm Description
    Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff.
    Intervention Type
    Behavioral
    Intervention Name(s)
    OUD Telehealth Platform
    Intervention Description
    The platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users
    Primary Outcome Measure Information:
    Title
    Attendance for MOUD
    Description
    Overall attendance will be measured by attendance (yes or no) at the first buprenorphine appointment within 30 days of referral.
    Time Frame
    Up to 30 Days
    Secondary Outcome Measure Information:
    Title
    Engagement with MOUD
    Description
    Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of referral.
    Time Frame
    Up to 90 days
    Title
    Overdose Events at 30 Days
    Description
    A self-report of the number of subsequent overdose events at 30 days.
    Time Frame
    Up to 30 days
    Title
    Overdose Events at 90 Days
    Description
    A self-report of the number of subsequent overdose events at 90 days.
    Time Frame
    Up to 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Can speak, read and write in English Provision of signed and dated informed consent form Have a history of at least one opioid overdose Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer) OR be willing to use a device provided by the study team Can provide a working email address OR be willing to create one Exclusion Criteria: Current use of buprenorphine, methadone, or naltrexone for a substance use disorder Pregnancy or lactation Known current suicide risk based on participant self-report On parole or incarcerated at time of enrollment based on participant self-report
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebekah Heckmann, MD, MPH, MPA
    Phone
    (203) 737-8335
    Email
    rebekah.heckmann@yale.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Pantalon, PhD
    Phone
    (203) 785-4363
    Email
    michael.pantalon@yale.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rebekah Heckmann, MD, MPH, MPA
    Organizational Affiliation
    Yale School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be shared as part of the HEAL Initiative Consortium.
    IPD Sharing Time Frame
    Following the close of the study and final reporting to funder.

    Learn more about this trial

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