NCT05832879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

April 14, 2023

Last Update Submit

September 30, 2025

Conditions

Keywords

Harm ReductionMedication for Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Engagement with MOUD

    Up to 90 days

  • Overdose Events at 30 Days

    Up to 30 days

  • Overdose Events at 90 Days

    Up to 90 days

Study Arms (1)

OUD Telehealth Platform

EXPERIMENTAL

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

Behavioral: OUD Telehealth Platform

Interventions

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

OUD Telehealth Platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Canty T, S Sabounchi N, Heimer R, Pantalon M, Ryus C, Buchanan L, Grewal M, Maffei J, D'Onofrio G, Heckmann R. Increasing timely access to evidence-based treatment for opioid use disorder using novel digital health and system dynamics modelling approaches: a study protocol. BMJ Open. 2025 Nov 4;15(11):e102796. doi: 10.1136/bmjopen-2025-102796.

MeSH Terms

Conditions

Opioid-Related DisordersHarm Reduction

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Rebekah Heckmann, MD, MPH, MPA

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 27, 2023

Study Start

May 1, 2024

Primary Completion

July 24, 2025

Study Completion

July 24, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Data will be shared as part of the HEAL Initiative Consortium.

Time Frame
Following the close of the study and final reporting to funder.

Locations