Telehealth Treatment for Opioid Use Disorders

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05832879
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
30
1
15

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: OUD Telehealth Platform
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Telehealth Treatment for Opioid Use Disorders
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: OUD Telehealth Platform

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

Behavioral: OUD Telehealth Platform
The platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users

Outcome Measures

Primary Outcome Measures

  1. Attendance for MOUD [Up to 30 Days]

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

Secondary Outcome Measures

  1. Engagement with MOUD [Up to 90 days]

    Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of referral.

  2. Overdose Events at 30 Days [Up to 30 days]

    A self-report of the number of subsequent overdose events at 30 days.

  3. Overdose Events at 90 Days [Up to 90 days]

    A self-report of the number of subsequent overdose events at 90 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yale University
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Rebekah Heckmann, MD, MPH, MPA, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05832879
Other Study ID Numbers:
  • 2000034414
  • 1R61DA057675-01
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023