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Clinical Trials/NCT07362082
NCT07362082
Not yet recruiting
Not Applicable

A Randomized Clinical Trial of Telehealth Treatment for Opioid Use Disorders

Yale University1 site in 1 country470 target enrollmentStarted: April 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
470
Locations
1
Primary Endpoint
Mean time to first buprenorphine prescription

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 or lactation
  • Known current suicide risk based on participant self-report
  • On parole or incarcerated at time of enrollment based on participant self-report

Arms & Interventions

RecoveryPad platform

Experimental

Participants randomized to RecoveryPad platform

Intervention: RecoveryPad platform (Device)

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.

Outcomes

Primary Outcomes

Mean time to first buprenorphine prescription

Time Frame: 30 days post enrollment

Mean time to first buprenorphine prescription within 30 days of engagement with RP.

Secondary Outcomes

  • Number of participants with current MOUD prescription(90 days post enrollment)
  • Mean number overdose events(30 and 90 days post enrollment)
  • Number of participants with methadone referral and induction(90 days post enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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