NCT07362082

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

January 21, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

January 21, 2026

Last Update Submit

July 23, 2026

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Attendance for MOUD

    Up to 90 days

  • 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 (2)

RecoveryPad platform

EXPERIMENTAL

Participants randomized to RecoveryPad platform

Device: RecoveryPad platform

Treatment as usual

NO INTERVENTION

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.

Interventions

RecoveryPad platformDEVICE

Telehealth platform to enhance motivation and engagement in treatment for OUD

RecoveryPad 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
  • 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

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 University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Rebekah Heckmann, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Nasim Sabounchi, PhD

    CUNY Graduate School of Public Health & Health Policy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebekah Heckmann, MD

CONTACT

(203) 737-8335rebekah.heckmann@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 23, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

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.
Access Criteria
All shared data and associated supporting documentation will be uploaded to the National Addiction and Health Data Archive Program.
More information

Locations

US(1)