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NCT Number: NCT07778394

Personalized Addiction Treatment eHancement

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Peer Support Substance-Related Disorders mHealth

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Evan Ames

CONTACT

[email protected]

401-444-2474

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Medication for Opioid Use Disorder Retention

    Time frame: Baseline & 3-Month Follow-up

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

  2. Substance Use Disorder Treatment Engagement

    Time frame: Baseline & 3-Month Follow-up

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

Secondary outcomes

  1. Opioid Use assessed with the Timeline Follow-back

    Time frame: Baseline & 3-Month Follow-up

    Self-reported opioid use will be assessed with a Timeline Follow-back interview and biochemically confirmed with Urine Drug Screens. The timeline follow-back is an established semi-structured interview format used to cue accurate recall about substance use. Opioid use will be operationalized as the percentage of days of opioid use in between assessments.

  2. Opioid Craving measured with the Opioid Craving Scale

    Time frame: Baseline & 3-Month Follow-up

    The Opioid Craving Scale will be used to assess opioid craving. This assessment has been used extensively in assessments of opioid recovery demonstrating internal consistency, reliability, and concurrent and predictive validity.

  3. Anhedonia assessed with the Snaith-Hamilton Pleasure Scale

    Time frame: Baseline & 3-Month Follow-up

    The degree to which participants experience anhedonic symptoms will be measured with the Snaith-Hamilton Pleasure Scale. This questionnaire is a psychometrically sound assessment of anhedonia. Higher scores represent greater anhedonia.

  4. Sleep Deficiency assessed with the Insomnia Severity Index (ISI)

    Time frame: Baseline & 3-Month Follow-up

    Sleep deficiency will be assessed with the Insomnia Severity Index (ISI), a widely used questionnaire with strong internal consistency, reliability, and convergent validity. Higher scores represent greater sleep deficiency.

  5. Negative Affect assessed with the Positive Affect and Negative Affect Schedule-Expanded Form

    Time frame: Baseline & 3-Month Follow-up

    The Positive Affect and Negative Affect Schedule-Expanded Form (PANAS-X) will be utilized to assess negative affect. The PANAS-X is a popular assessment of negative affect and boasts strong psychometric properties. Higher scores represent greater negative affect.

  6. Perceived Quality of Life Measured with the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form

    Time frame: Baseline & 3-Month Follow-up

    Perceived quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. This 16-item questionnaire has shown internal consistency, test-retest reliability, and convergent and criterion validity. Higher scores represent greater perceived quality of life.

  7. Wellbeing measured by the World Health Organization-Five Well-Being Index

    Time frame: Baseline & 3-Month Follow-up

    Wellbeing will be assessed by the World Health Organization-Five Well-Being Index, a widely used 5-item questionnaire. Higher scores represent greater wellbeing.

  8. Perceived Social Support assessed with the Multidimensional Scale of Perceived Social Support

    Time frame: Baseline & 3-Month Follow-up

    Social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS), a psychometrically sound assessment that has demonstrated adequate reliability and validity, including robust factorial validity, and measures perceived social support from different sources. Higher scores represent greater perceived social support.

  9. Participant Safety

    Time frame: Baseline & 3-Month Follow-up

    All adverse events during the course of the study will be documented. Participant safety will be comprised of the frequency of adverse events.

Other outcomes

  1. Demographics assessed with the PhenX Toolkit

    Time frame: Baseline

    Using the PhenX toolkit, standard demographic information and social determinants of health will be collected at baseline to characterize our sample of participants.

  2. Vira Path Usability assessed with the System Usability Scale

    Time frame: 3-Month Follow-up

    The System Usability Scale will be administered to participants to determine the usability of Vira Path. Higher scores represent greater usability.

  3. Vira Path Acceptability assessed with the System Usability Scale

    Time frame: 3-Month Follow-up

    The System Usability Scale will be administered to participants to determine the acceptability of Vira Path. Higher scores represent greater acceptability.

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Ames

CONTACT

[email protected]

401-444-2474

Susan Ramsey, PhD

CONTACT

[email protected]

401-444-7831

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Ksana Health

Registry information

Official study title

The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder

Acronym: Project Path

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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