Personalized Addiction Treatment enHancement

NCT07778394 | Recruiting DMC

• 1 other identifier: UG3DA061495
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Peer Recovery Support; Digital Support

Outcome Measures

Primary Outcomes (2)

• Medication for Opioid Use Disorder Retention

  Retention on buprenorphine or methadone treatment will be verified through medical record chart review.

  Baseline & 3-Month Follow-up

• Substance Use Disorder Treatment Engagement

  Addiction treatment records as assessed through medical records will be assessed for participation in addiction treatment services (e.g., 'detox', inpatient services, outpatient therapy).

  Baseline & 3-Month Follow-up

Secondary Outcomes (9)

• Opioid Use assessed with the Timeline Follow-back

  Baseline & 3-Month Follow-up

• Opioid Craving measured with the Opioid Craving Scale

  Baseline & 3-Month Follow-up

• Anhedonia assessed with the Snaith-Hamilton Pleasure Scale

  Baseline & 3-Month Follow-up

• Sleep Deficiency assessed with the Insomnia Severity Index (ISI)

  Baseline & 3-Month Follow-up

• Negative Affect assessed with the Positive Affect and Negative Affect Schedule-Expanded Form

  Baseline & 3-Month Follow-up

Other Outcomes (3)

• Demographics assessed with the PhenX Toolkit

  Baseline

• Vira Path Usability assessed with the System Usability Scale

  3-Month Follow-up

• Vira Path Acceptability assessed with the System Usability Scale

  3-Month Follow-up

Study Arms (2)

Vira Path

EXPERIMENTAL

Behavioral: Vira Platform; Behavioral: Treatment-As-Usual

Treatment-as-Usual

ACTIVE COMPARATOR

Behavioral: Treatment-As-Usual

Interventions

Vira Platform BEHAVIORAL

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.

Vira Path

Treatment-As-Usual BEHAVIORAL

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.

Treatment-as-Usual; Vira Path

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Ksana Health: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Susan Ramsey, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Ramsey, PhD

CONTACT

401-444-7831; sramsey@brownhealth.org

Evan Ames

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: August 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)