An interventional study of Vira Platform and Treatment-As-Usual in Opioid Use Disorder, mHealth and Peer Support, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Treatment
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 40 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Vira Platform · Behavioral: Treatment-As-Usual
Behavioral: Treatment-As-Usual
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.
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.
Medication for Opioid Use Disorder Retention
Retention on buprenorphine or methadone treatment will be verified through medical record chart review.
Time frame: 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).
Time frame: Baseline & 3-Month Follow-up
Opioid Use assessed with the Timeline Follow-back
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.
Time frame: Baseline & 3-Month Follow-up
Opioid Craving measured with the Opioid Craving Scale
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. Scores range from 0 to 10, with higher scores representing greater opioid craving.
Time frame: Baseline & 3-Month Follow-up
Anhedonia assessed with the Snaith-Hamilton Pleasure Scale
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.
Time frame: Baseline & 3-Month Follow-up
Sleep Deficiency assessed with the Insomnia Severity Index (ISI)
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.
Time frame: Baseline & 3-Month Follow-up
Negative Affect assessed with the Positive Affect and Negative Affect Schedule-Expanded Form
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.
Time frame: Baseline & 3-Month Follow-up
Perceived Quality of Life Measured with the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
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.
Time frame: Baseline & 3-Month Follow-up
Wellbeing measured by the World Health Organization-Five Well-Being Index
Wellbeing will be assessed by the World Health Organization-Five Well-Being Index, a widely used 5-item questionnaire. Higher scores represent greater wellbeing.
Time frame: Baseline & 3-Month Follow-up
Perceived Social Support assessed with the Multidimensional Scale of Perceived Social Support
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.
Time frame: Baseline & 3-Month Follow-up
Participant Safety
All adverse events during the course of the study will be documented. Participant safety will be comprised of the frequency of adverse events.
Time frame: Baseline & 3-Month Follow-up
Demographics assessed with the PhenX Toolkit
Using the PhenX toolkit, standard demographic information and social determinants of health will be collected at baseline to characterize our sample of participants.
Time frame: Baseline
Vira Path Usability assessed with the System Usability Scale
The System Usability Scale will be administered to participants to determine the usability of Vira Path. Higher scores represent greater usability.
Time frame: 3-Month Follow-up
Vira Path Acceptability assessed with the System Usability Scale
The System Usability Scale will be administered to participants to determine the acceptability of Vira Path. Higher scores represent greater acceptability.
Time frame: 3-Month Follow-up
Plan to share: No
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