Personalized Addiction Treatment enHancement

ConditionsOpioid Use Disorder mHealth Peer Support

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22+

SponsorRhode Island Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 22+

Current Opioid Use Disorder diagnosis

Prescribed buprenorphine or methadone

Initiated or reinitiated buprenorphine or methadone treatment recently

Disqualifiers

Not fluent in English

Limited mental capacity or inability to provided informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Vira PathExperimental treatment 2 interventions

Group B: Treatment-as-UsualActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhode Island Hospital

Lead sponsor

Ksana Health

Collaborator

Source ClinicalTrials.gov

Apply now