Recruiting

Digital Platform with Buprenorphine & Methadone

Sponsor:

Rhode Island Hospital

Code:

NCT07778394

Conditions

Opioid Use Disorder

mHealth

Peer Support

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Vira Platform

Treatment-As-Usual

Study Details

Brief summary:

Many patients stop medication-based treatments for Opioid Use Disorder (OUD) prematurely, placing them at increased risk for overdose and death. Providing targeted interventions for OUD, particularly through an accessible, digital health platform, is a potential way to enhance recovery and keep patients engaged in care. The current study seeks to test whether a digital mental health platform, delivered by peer recovery support specialists to individuals prescribed buprenorphine or methadone medication, will improve treatment outcomes for this high risk population.

Conditions

Opioid Use Disorder

mHealth

Peer Support

Study ID

NCT07778394

Start date

Aug 13, 2026

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 22+
  • Current Opioid Use Disorder diagnosis
  • Prescribed buprenorphine or methadone
  • Initiated or reinitiated buprenorphine or methadone treatment recently
  • Access to personal smartphone

Exclusion Criteria:

  • Not fluent in English
  • Limited mental capacity or inability to provided informed consent

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vira Path

active comparator: Treatment-as-Usual

Interventions

Vira Platform

The Vira Platform is a digitally enhanced mental health care platform consisting of a patient smartphone application that utilizes mobile sensing to garner insight about patterns of behavior related to negative affect, sleep, and anhedonia while simultaneously providing just-in-time nudges to increase positive interactions with the environment. Behavioral activation is the primary intervention being deployed through the Vira App. It is accompanied by a practitioner platform that is delivered through certified peer recovery support specialist to encourage engagement with the app and promote social support.

Treatment-As-Usual

The treatment-as-usual condition consists of standard outpatient buprenorphine or methadone treatment. These medications are among those considered to be the gold standard of care for treating opioid use disorder, and therefore, represents an adequate control intervention for this study.

Primary outcome measure

  • Medication for Opioid Use Disorder Retention [ Time Frame: Baseline & 3-Month Follow-up ]
  • Substance Use Disorder Treatment Engagement [ Time Frame: Baseline & 3-Month Follow-up ]

Central Contacts and Locations

Central contacts

Susan Ramsey, PhD

401-444-7831sramsey@brownhealth.org

Evan Ames

401-444-2474evan.ames@brownhealth.org

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Evan Ames

401-444-2474evan.ames@brownhealth.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Peer Recovery Support
  • Digital Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-08-26.