Telehealth Treatment for Opioid Use Disorders

A Pilot Study of Telehealth Treatment for Opioid Use Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: OUD Telehealth Platform

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebekah Heckmann, MD, MPH, MPA; Phone Number: (203) 737-8335; Email: rebekah.heckmann@yale.edu
• Study Contact Backup: Name: Michael Pantalon, PhD; Phone Number: (203) 785-4363; Email: michael.pantalon@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OUD Telehealth Platform; Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Rebekah Heckmann, MD, MPH, MPA, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Harm Reduction; Medication for Opioid Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000034414; 1R61DA057675-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared as part of the HEAL Initiative Consortium.
• IPD Sharing Time Frame: Following the close of the study and final reporting to funder.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No