Opioid-use DisorderNCT05017272
Technology for MAT in Primary Care - Phase 2
A study testing Opioid Addiction Recovery Support Software Platform in people with Opioid-use Disorder, run by Q2i, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Opioid Addiction Recovery Support Software Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Primary Care Providers (PCPs):
- Physician, nurse practitioner, or physician's assistant in any area within primary care;
- In possession of valid DATA-2000 waiver;
- Currently treating more than two patients with OUD using oral buprenorphine-naloxone product;
- Willing to distribute study materials to their patients describing the research and providing options for their participation.
- For Patient participants:
- Diagnosed and treated using MAT within primary care setting (i.e., family medicine, internal medicine, adolescent medicine, pediatrics, obstetrics/gynecology, geriatrics, infectious diseases, emergency department, non-cancer pain management).
Who cannot join
- For PCPs:
- Specialization outside primary care (e.g., psychiatry, neurology, etc) or provider works in specialized setting (e.g., addiction treatment programs; mental health clinic);
- Not treating patients with OUD with oral buprenorphine-naloxone product (e.g., long-acting naltrexone or buprenorphine injections);
- Individual interviews with physicians and their patients to discuss initially barriers and challenges to MAT for patients with OUD seen in primary care settings.
- For Patient participants:
- MAT delivered in specialty care settings (i.e., psychiatry, substance abuse treatment programs).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Behavioral and Addiction Medicine
Los Angeles, California, 90024
About this study
Official title: Technology Improving Success of Medication-Assisted Treatment in Primary Care - Phase 2
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.
- Conditions
- Opioid-use Disorder
- Being tested
- Opioid Addiction Recovery Support Software Platform
- Keywords
- Opioid use disorder, Primary care, mHealth, Medication for opioid use disorder, Technological solutions
- 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.
Opioid Addiction Recovery Support Software PlatformOther
Also called OARS
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Addiction Recovery Support (OARS) | Active comparator | Data collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites. Receives: Other: Opioid Addiction Recovery Support Software Platform |
| Treatment as Usual | No intervention | Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Secondary outcomes (1)
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.
Measured: OARS implementation period (start of intervention through to study completion, up to 10 months). Time Frames for the OARS periods differ by site.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 May 2021
- Primary completion31 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Using a "stepped wedge" effectiveness design, evaluate OARS platform in 6 treatment programs (N=200 treated patients) data before and after implementation along MAT outcomes. Each clinic, once randomized to begin using OARS, will have a minimum of 4 months and a maximum of 12 months to collect baseline data on the number of PCPs who have DATA-2000 waivers, on the number of patients each PCP treats and on relevant patient outcomes to MAT (e.g., length of time in treatment, visits kept with PCP and psychosocial providers, number of drug-free urine tests). There will be four months of baseline data available for PCPs and patients defined as treatment as usual (TAU) for clinics 1 and 2, eight months of baseline data available for PCPs and patients defined as TAU for clinics 3 and 4 and 12 months of baseline data available for PCPs and patients defined as TAU for clinics 5 and 6. In the final 3 months, we will finish data analyses, prepare papers for dissemination in peer-reviewed journals.
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Q2i, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Steven J Shoptaw, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017272
- Sponsor's protocol ID
- 20-001516
- Other IDs
- 4R42DA050398-02, 5R42DA050398-03
- Status last verified
- May 2025
- First submitted
- 12 Aug 2021
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Improving Success of Medication-Assisted Treatment in Primary Care - Phase 2
- ClinicalTrials.gov ID
- NCT05017272
- Acronym / sponsor ID
- 20-001516
- Conditions
- Opioid-use Disorder
- Keywords
- Opioid use disorder, Primary care, mHealth, Medication for opioid use disorder, Technological solutions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Q2i, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institute on Drug Abuse (NIDA)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a "stepped wedge" effectiveness design, evaluate OARS platform in 6 treatment programs (N=200 treated patients) data before and after implementation along MAT outcomes. Each clinic, once randomized to begin using OARS, will have a minimum of 4 months and a maximum of 12 months to collect baseline data on the number of PCPs who have DATA-2000 waivers, on the number of patients each PCP treats and on relevant patient outcomes to MAT (e.g., length of time in treatment, visits kept with PCP and psychosocial providers, number of drug-free urine tests). There will be four months of baseline data available for PCPs and patients defined as treatment as usual (TAU) for clinics 1 and 2, eight months of baseline data available for PCPs and patients defined as TAU for clinics 3 and 4 and 12 months of baseline data available for PCPs and patients defined as TAU for clinics 5 and 6. In the final 3 months, we will finish data analyses, prepare papers for dissemination in peer-reviewed journals.
| Arm | Type | Receives |
|---|---|---|
| Opioid Addiction Recovery Support (OARS) | Active comparator | Other: Opioid Addiction Recovery Support Software PlatformData collected post-implementation of OARS in conjunction with medication for opioid use disorder (MOUD) at study sites. |
| Treatment as Usual | No intervention | –Data collected at baseline before OARS in conjunction with MOUD is implemented at study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For Primary Care Providers (PCPs):
- For Patient participants:
Key exclusion criteria (6 listed)
- For PCPs:
- For Patient participants:
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 |
|---|---|---|
| Opioid Addiction Recovery Support Software PlatformAlso: OARSOARS (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. | Other | Opioid Addiction Recovery Support (OARS) |
Primary outcome
Urine Drug Screening Test Results
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.
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).
Appointment Attendance
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.
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).
1 secondary outcome
OARS Features Use
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Further information about the OARS solution available here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Steven J Shoptaw, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Addiction Recovery Support Software Platform in people with Opioid-use Disorder, run by Q2i, LLC 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 2025. 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?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Drug Screening Test Results (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.). 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 6 May 2025.