Telehealth Treatment for Opioid Use Disorders

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder
• Interventions: Behavioral: OUD Telehealth Platform

• Registration Number: NCT05832879
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-27
• Study Start: 2024-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States