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Clinical Trials/NCT05832879
NCT05832879
Completed
N/A

A Pilot Study of Telehealth Treatment for Opioid Use Disorders

Yale University1 site in 1 country33 target enrollmentMay 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
Yale University
Enrollment
33
Locations
1
Primary Endpoint
Attendance for MOUD
Status
Completed
Last Updated
6 months ago

Overview

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. 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
July 24, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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
  • Known current suicide risk based on participant self-report
  • On parole or incarcerated at time of enrollment based on participant self-report

Outcomes

Primary Outcomes

Attendance for MOUD

Time Frame: 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 Outcomes

  • Overdose Events at 90 Days(Up to 90 days)
  • Engagement with MOUD(Up to 90 days)
  • Overdose Events at 30 Days(Up to 30 days)

Study Sites (1)

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