An interventional study of Opioid Addiction Recovery Support Software Platform in Opioid-use Disorder, sponsored by Q2i, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Q2i, LLC · Not applicable, Interventional, and Health services research
With over 72,000 overdose deaths in 2017, of which 47,600 are attributable to opioid overdose, the opioid epidemic has become North America's most widespread behavioral public health problem. Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious. The Opioid Addiction Recovery Support (OARS), comprised of a healthcare team portal connected to a patient mobile application, provides opioid-related education, promotes connectedness with clinicians, and tracks MAT treatment progress. This study will conduct interviews with patients that will inform optimal design of OARS, assess the efficacy of OARS in improving MAT outcomes in primary care settings, and evaluate the sustainability and return on investment.
It joins an outstanding scientific team at University of California, Los Angeles and a small business that has developed, Opioid Addiction Recovery Support (OARS) -- a software platform that by integrating with the Electronic Health Record (EHR) improves clinical management of patients by primary care providers (PCPs) treating patients with OUD using MAT. OARS platform uses a dashboard to show the real-time measurement of patient achievements in recovery. It provides opportunities for patients to interact with their PCPs, allowing for better connection to and support from their PCPs. OARS platform features artificial intelligence to analyze information from the EHR and from patients to provide a relapse risk assessment for patients receiving MAT for OUD, an innovation that sets OARS apart from other software solutions. The goal of Phase 1 was to modify the OARS platform for use in primary care settings by conducting interviews with Primary Care Physicians (PCPs) (N=20) and their patients with OUD (N=40) in primary care settings to collect data on feasibility and acceptability of engaging with OARS to inform the user-centered design of OARS.
The goals of Phase 2 of this study are to: (1) to assess the effectiveness of OARS in improving opioid agonist treatment outcomes across 6 treatment programs (N=200 treated patients) and (2) evaluate the sustainability and return on investment of OARS implementation across 6 treatment programs. A commercialization plan documents progress to date for the OARS platform and presents a market plan to improve both the scale and quality of MAT services delivered by PCPs in primary care, which is a major contribution to addressing the ongoing opioid epidemic.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 246 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Q2i, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
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For Primary Care Providers (PCPs):
For Patient participants:
Exclusion Criteria:
For PCPs:
For Patient participants:
Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites.
Other: Opioid Addiction Recovery Support Software Platform
Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites.
OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
Also known as: OARS
Urine Drug Screening Test Results
Percent of participants who had positive urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis. During the TAU period (pre-intervention), the percentage of all patient drug screens that were positive was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Appointment Attendance
Percent of appointments scheduled and kept with Primary Care Provider. During the TAU period (pre-intervention), the percentage of attended appointments was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
OARS Features Use
Type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature (times viewed per week). During the OARS implementation period (post-intervention), the type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature were calculated.
Time frame: OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site.
Return on Investment (ROI)
ROI for a MAT provider using OARS compared to TAU. During the TAU period (pre-intervention), the ROI for MAT providers was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Counts of Services/Medications Received by Patients
Including but not limited to visits, medications filled, reminder calls, asynchronous video related to OUD care. During the TAU period (pre-intervention), the counts of services/medications received by patients were determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
Additional Healthcare Utilization by Patients
Number of Emergency Department visits, Number of Medicaid charges, Number of inpatient stays, Number of other medications. During the TAU period (pre-intervention), healthcare utilization by patients was determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Time frame: Comparison of TAU baseline period (prior to start of intervention, up to 13 months) to OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the TAU and OARS periods differ by site.
This study utilized a non-randomized, stepped-wedge effectiveness trial design, which facilitates data collection on patient outcomes prior to the OARS intervention. Sites were purposefully selected and assigned to clusters as they were identified; one site in sequence 1, two sites in sequence 2, and one site in sequence 3. 11 PCPs were enrolled in the study but only participated in semi-structured interviews to provide their insights on the OARS intervention.
| Milestone | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention |
|---|---|---|---|
| Started | 140 | 3 | 12 |
| Completed | 140 | 3 | 12 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention |
|---|---|---|---|
| Started | 205 | 8 | 12 |
| Completed | 205 | 8 | 12 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention |
|---|---|---|---|
| Started | 205 | 8 | 12 |
| Completed | 205 | 8 | 12 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention |
|---|---|---|---|
| Started | 205 | 8 | 22 |
| Completed | 205 | 8 | 22 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention |
|---|---|---|---|
| Started | 0 | 8 | 22 |
| Completed | 0 | 8 | 22 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: Months 1-4 TAU, Months 5-14 OARS Intervention | Sequence 2: Months 1-7 TAU, Months 8-17 OARS Intervention | Sequence 3: Months 1-13 TAU, Months 14-23 OARS Intervention |
|---|---|---|---|
| Started | 0 | 0 | 22 |
| Completed | 0 | 0 | 22 |
| Not completed | 0 | 0 | 0 |
Percent of participants who had positive urine screening tests for buprenorphine, opioids (heroin, synthetics, fentanyl), cocaine, methamphetamine, benzodiazepines, cannabis. During the TAU period (pre-intervention), the percentage of all patient drug screens that were positive was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
| percentage of participants positive | Opioid Addiction Recovery Support (OARS) | Treatment as Usual |
|---|---|---|
| Buprenorphine | 92.3 | 92.0 |
| Opioids (heroin, synthetics, fentanyl) | 1.9 | 2.0 |
| Cocaine | 1.3 | 1.8 |
| Methamphetamine/Amphetamines | 0.9 | 2.0 |
| Benzodiazepines | 4.1 | 1.6 |
| Cannabis | 37.5 | 35.8 |
Percent of appointments scheduled and kept with Primary Care Provider. During the TAU period (pre-intervention), the percentage of attended appointments was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
| percentage of appointments attended | Opioid Addiction Recovery Support (OARS) | Treatment as Usual |
|---|---|---|
| Appointment Attendance | 91.5 | 91.0 |
Type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature (times viewed per week). During the OARS implementation period (post-intervention), the type of OARS mobile phone app feature accessed by patient and level of patient involvement with each feature were calculated.
| times used per week | Opioid Addiction Recovery Support (OARS) |
|---|---|
| Viewed test results | 5 (0.0 to 7.5) |
| Viewed progress | 1 (0.0 to 3.0) |
| Viewed educational content | 1 (0.0 to 2.0) |
| Sent chat message | 0 (0.0 to 3.0) |
| Created journal entry | 0 (0.0 to 1.0) |
ROI for a MAT provider using OARS compared to TAU. During the TAU period (pre-intervention), the ROI for MAT providers was calculated. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Results for this outcome have not been posted.
Including but not limited to visits, medications filled, reminder calls, asynchronous video related to OUD care. During the TAU period (pre-intervention), the counts of services/medications received by patients were determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Results for this outcome have not been posted.
Number of Emergency Department visits, Number of Medicaid charges, Number of inpatient stays, Number of other medications. During the TAU period (pre-intervention), healthcare utilization by patients was determined. The same was done during the OARS implementation period (post-intervention) for comparison with the TAU period (baseline).
Results for this outcome have not been posted.
Collected over 2 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opioid Addiction Recovery Support (OARS) | 0/235 (0%) | 0/235 (0%) | 0/235 (0%) |
| Treatment as Usual | 0/155 (0%) | 0/155 (0%) | 0/155 (0%) |
This study utilized a retrospective cohort-style, step-wedged trial design, which was based on cohort sampling (i.e., the same patients in each sequence were followed in each step from TAU to OARS). Patient Baseline Characteristic data were collected when participants started OARS. 11 PCPs were enrolled in the study but only participated in semi-structured interviews to provide their insights on the OARS intervention. No other data was captured for PCPs.
| Age, Continuous(years) | Study Participants |
|---|---|
| Median | 37 (32 to 44) |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 88 |
| Male | 147 |
| Race/Ethnicity, Customized(Participants) | Study Participants |
|---|---|
| Hispanic or Latino | 5 |
| Non-Hispanic Black or African American | 10 |
| Non-Hispanic White | 212 |
| Non-Hispanic other race | 8 |
| Region of Enrollment(participants) | Study Participants |
|---|---|
| United States | 235 |
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