Telehealth Treatment for Opioid Use Disorders

Opioid Use Disorder Clinical Trial

Official title:

A Pilot Study of Telehealth Treatment for Opioid Use Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832879
• Other study ID #: 2000034414
• Secondary ID: 1R61DA057675-01
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Rebekah Heckmann, MD, MPH, MPA
• Phone: (203) 737-8335
• Email: rebekah.heckmann[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

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