Telehealth Treatment for Opioid Use Disorders

Yale University

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Behavioral: OUD Telehealth Platform

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05832879

1R61DA057675-01 (U.S. NIH Grant/Contract)

2000034414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• Known current suicide risk based on participant self-report
• On parole or incarcerated at time of enrollment based on participant self-report

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

OUD Telehealth Platform

Experimental group

Description:

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

Treatment:

Behavioral: OUD Telehealth Platform