Telehealth Treatment for Opioid Use Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Telehealth Treatment for Opioid Use Disorders

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Behavioral: OUD Telehealth Platform


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OUD Telehealth Platform<br>Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff. | Behavioral: OUD Telehealth Platform<br>* The platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance for MOUD | Overall attendance will be measured by attendance (yes or no) at the first buprenorphine appointment within 30 days of referral. | Up to 30 Days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Harm Reduction, Medication for Opioid Use Disorder