Opioid Use DisorderProject PathNCT07778394
Personalized Addiction Treatment enHancement
A study testing Vira Platform and Treatment-As-Usual in people with Opioid Use Disorder and mHealth, run by Rhode Island Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Opioid Use Disorder, mHealth, Peer Support
- What is being tested?
- Vira Platform and Treatment-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22+
- Current Opioid Use Disorder diagnosis
- Prescribed buprenorphine or methadone
- Initiated or reinitiated buprenorphine or methadone treatment recently
- Access to personal smartphone
Who cannot join
- Not fluent in English
- Limited mental capacity or inability to provided informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Evan Ames, 401-444-2474, evan.ames@brownhealth.org
About this study
Official title: The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder
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
- Being tested
- Vira Platform, Treatment-As-Usual
- Keywords
- Peer Recovery Support, Digital Support
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vira PlatformBehavioural
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-UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vira Path | Experimental | Not described Receives: Behavioral: Vira Platform; Behavioral: Treatment-As-Usual |
| Treatment-as-Usual | Active comparator | Not described Receives: Behavioral: Treatment-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication for Opioid Use Disorder Retention
Retention on buprenorphine or methadone treatment will be verified through medical record chart review.
Measured: 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).
Measured: Baseline & 3-Month Follow-up
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline & 3-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start13 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ksana Health
- Responsible party
- Sponsor
- Investigators
- Susan Ramsey, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778394
- Sponsor's protocol ID
- UG3DA061495
- Acronym
- Project Path
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07778394
- Acronym / sponsor ID
- Project Path / UG3DA061495
- Conditions
- Opioid Use Disorder, mHealth, Peer Support
- Keywords
- Peer Recovery Support, Digital Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Ksana Health
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vira Path | Experimental | Behavioral: Vira Platform, Behavioral: Treatment-As-Usual |
| Treatment-as-Usual | Active comparator | Behavioral: Treatment-As-Usual |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 22+
- Current Opioid Use Disorder diagnosis
- Prescribed buprenorphine or methadone
- Initiated or reinitiated buprenorphine or methadone treatment recently
- Access to personal smartphone
Key exclusion criteria (2 listed)
- Not fluent in English
- Limited mental capacity or inability to provided informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vira PlatformThe 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. | Behavioural | Vira Path |
| Treatment-As-UsualThe 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. | Behavioural | Treatment-as-Usual, Vira Path |
Primary outcome
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.
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).
9 secondary outcomes
Opioid Use assessed with the Timeline Follow-back
Time frame: Baseline & 3-Month Follow-up
Opioid Craving measured with the Opioid Craving Scale
Time frame: Baseline & 3-Month Follow-up
Anhedonia assessed with the Snaith-Hamilton Pleasure Scale
Time frame: Baseline & 3-Month Follow-up
Sleep Deficiency assessed with the Insomnia Severity Index (ISI)
Time frame: Baseline & 3-Month Follow-up
Negative Affect assessed with the Positive Affect and Negative Affect Schedule-Expanded Form
Time frame: Baseline & 3-Month Follow-up
Perceived Quality of Life Measured with the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form
Time frame: Baseline & 3-Month Follow-up
Wellbeing measured by the World Health Organization-Five Well-Being Index
Time frame: Baseline & 3-Month Follow-up
Perceived Social Support assessed with the Multidimensional Scale of Perceived Social Support
Time frame: Baseline & 3-Month Follow-up
Participant Safety
Time frame: Baseline & 3-Month Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Ramsey, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vira Platform and Treatment-As-Usual in people with Opioid Use Disorder and mHealth, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Ramsey, PhD (401-444-7831, sramsey@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication for Opioid Use Disorder Retention (time frame: Baseline & 3-Month Follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.