Telehealth Treatment for Opioid Use Disorders

NCT ID: NCT05832879

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-07-24

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. 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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OUD Telehealth Platform

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

Group Type: EXPERIMENTAL

OUD Telehealth Platform

Intervention Type: BEHAVIORAL

The platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebekah Heckmann, MD, MPH, MPA

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R61DA057675-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000034414

Identifier Type: -

Identifier Source: org_study_id