A Clinical Trial of Telehealth Treatment for Opioid Use Disorders

Yale University

Status: Not yet enrolling

Conditions: Opioid Use Disorder

Treatments: Device: RecoveryPad platform

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07362082

4R33DA057675-02 (U.S. NIH Grant/Contract)

1R61DA057675-01 (U.S. NIH Grant/Contract)

2000041129

Details and patient eligibility

About

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

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 2 patient groups

RecoveryPad platform

Experimental group

Description:

Participants randomized to RecoveryPad platform

Treatment:

Device: RecoveryPad platform

Treatment as usual

No Intervention group

Description:

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.