A Clinical Trial of Telehealth Treatment for Opioid Use Disorders

A Randomized Clinical Trial of Telehealth Treatment for Opioid Use Disorders

This trial will assess effects of enrollment in a comprehensive telehealth platform, RecoveryPad (RP), in adults with moderate or severe opioid use disorder.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: RecoveryPad platform

• Study Type: Interventional
• Enrollment (Estimated): 470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebekah Heckmann, MD; Phone Number: (203) 737-8335; Email: rebekah.heckmann@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University

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
• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RecoveryPad platform; Participants randomized to RecoveryPad platform	Device: RecoveryPad platform; Telehealth platform to enhance motivation and engagement in treatment for OUD
No Intervention: Treatment as usual; Treatment as usual: referrals to harm reduction and other community resources that are already being given to individuals in the various community and healthcare settings from which these participants are being recruited.

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 MOUD appointment within 30 days of enrollment.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance for MOUD	Overall attendance will be measured by attendance (yes or no) at the first MOUD appointment within 31 to 90 days of enrollment.	Up to 90 days
Engagement with MOUD	Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of enrollment.	Up to 90 days
Overdose Events at 30 Days	A self-report of the number of subsequent overdose events within 30 days.	Up to 30 days
Overdose Events at 90 Days	A self-report of the number of subsequent overdose events within 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, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000041129; 1R61DA057675-01 (U.S. NIH Grant/Contract); 4R33DA057675-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with the HEAL Public Access and Data Sharing policy, de-identified IPD underlying the results reported in study-related publications will be shared. These will include participant-level data such as demographics/baseline characteristics, randomization results, and primary and secondary outcome measures.Direct identifiers will not be shared. Data will be de-identified using accepted standards.
• IPD Sharing Time Frame: The de-identified IPD and relevant supporting documentation will be available no later than 12 months after completion of primary analyses and publication of the primary results, or within the period required by the HEAL Initiative data sharing policy. Data will remain available for a minimum of 3 years after the initial release date, subject to repository support and other policy requirements.
• IPD Sharing Access Criteria: All shared data and associated supporting documentation will be uploaded to the National Addiction and Health Data Archive Program.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No