Opioid Use DisorderOARSCMNCT05180669
Reward-based Technology to Improve OUD Treatment
A study testing OARSCM Software Application and MyMAT Software Application in people with Opioid Use Disorder, run by Q2i, LLC at 1 site in United States.
Trial summary
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. 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?
- OARSCM Software Application and MyMAT Software Application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 31 May 2025
- 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
- >= 18 years old
- Presenting for acute care at UMass University and Memorial hospitals, including EDs, inpatient medical units, or inpatient behavioral health units for opioid addiction related health complaints, including opioid overdose, opioid related medical consequences, opioid intoxication or withdrawal syndromes, and/or seeking help for OUD
- Presence of a current DSM-V opioid use disorder (OUD), mild to severe
- Medically appropriate for outpatient Suboxone treatment, as judged by the treating clinician and behavioral health consultant or toxicologist working with the patient clinically
Who cannot join
- Persistent altered mental status (not alert, not oriented, psychotic).
- Not interested or willing to participate in Suboxone treatment
- Best referral site is NOT one of the study's partner clinics in the central MA region, which will be outpatient MAT clinics and primary care within the UMass system and the three other primary facilities outside of the UMass system.
- Unwilling to use the OARSCM app (if assigned)
- Does not have access to their own smartphone with at least iOS 7.1 or Android 4.2, the minimal technology required to run the app, or not willing to access clinic-dedicated computer to access the program
- Currently in state custody or pending legal action that might lead to imprisonment
Show all 10Show fewer
- Cannot paraphrase the study requirements
- Does not read or speak English
- Does not reside in the central MA region
- Already enrolled into the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 2
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This project will utilize a digital mobile platform, Opioid Addiction Recovery Support with contingency management (OARSCM), to increase MAT treatment initiation and adherence among OUD patients recruited from emergency departments and inpatient acute care.
Read the detailed description
Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests and are highly efficacious. An OARS solution enhanced with a CM component (OARSCM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARSCM using patient-centered design principles. Focus groups with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined, and the program iteratively updated. After meeting milestones, there was a proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers. After meeting milestones, this RCT will follow, in which acute care OUD patients appropriate for outpatient Suboxone (N = 102) are recruited and allocated to one of two study conditions: 1) treatment as usual (TAU) with MyMAT, comprised of screening, brief intervention, referral to treatment by a trained clinician, and an educational mobile app (MyMAT), 2) OARSCM. The active intervention window for the two intervention groups will be 12 weeks. Patients will be onboarded prior to discharge from acute care. In the outpatient Suboxone setting, data on treatment adherence and opioid use will be captured from clinical records for six months. Telephone follow-up assessments and vital statics registry reviews will be at month 1, month 3 (end-of-study intervention period), and month 6. Primary Suboxone treatment initiation outcomes will be completing the Suboxone intake. Primary Suboxone treatment outcomes will be sustained abstinence at Month 6 and longest duration of abstinence. Analysis will examine data on cost avoidance and cost savings through reduced acute care visits between study conditions.
- Conditions
- Opioid Use Disorder
- Being tested
- OARSCM Software Application, MyMAT Software Application
- Keywords
- Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OARSCM Software ApplicationOther
Also called Opioid Addiction Recovery Support - Contingency Management (OARSCM)
Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
MyMAT Software ApplicationOther
Also called MyMAT
Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment.
| Study group | Role | What they receive |
|---|---|---|
| OARSCM | Experimental | OARSCM (n = 21) patients will receive the same TAU procedures described above. They will also earn chances for prizes, with the same targeted behaviors, escalation of chances for prizes for each targeted behavior in a row, and reset criteria described. Briefly, for scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with documentation of each targeted behavior in a row up to a maximum of 10 draws/targeted behavior. With 38 targeted behaviors (schedule MOUD intake, complete intake, 12 opioid-negative urine toxicology/week over 12 weeks plus bonuses for cocaine-negative tests, and 12 group/individual therapy/week over 12 weeks), patients can earn up to 252 chances for prizes during the 12-week RCT. Receives: Other: OARSCM Software Application |
| TAU with MyMAT | Sham comparator | TAU (n = 20) In the acute care setting, the Behavioral Health Service provides SBIRT for substance use disorders, including OUD. They provide SBIRT as part of TAU, including a warm handoff to an outpatient MOUD treatment with a scheduled outpatient appointment, optimally within 48 hours of the ED visit. TAU outpatient suboxone treatment consists of urine toxicology screening, group/individual therapy, and MOUD prescription continent on drug-negative urine toxicology. Treatment visits are typically weekly in weeks 1-4 and then taper over time, to every other week in weeks 5-8, and monthly in weeks 9-12 and after. Nonadherence can lead to increased frequency/intensity of therapy and urine toxicology until the patient stabilizes. If increased frequency/intensity is unsuccessful, patients may be referred to detoxification and subsequently re-admitted to outpatient care when appropriate. Patients will receive MyMAT a mobile application with educational content regarding MOUD treatment. Receives: Other: MyMAT Software Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Outpatient Intake Scheduled - Phase 2 RCT
Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care
Measured: 1 timepoint - Before patients are discharged from acute care at the time of study enrollment
Percent Outpatient Intakes Completed - Phase 2 RCT
Percentage of patients who complete their outpatient Suboxone intake
Measured: Typically, within ~48 hours of discharge from acute care
Secondary outcomes (6)
Sustained Abstinence - Phase 2 RCT (Month 1)
Proportion of participants with sustained abstinence (composite of biochemical \& self-report data) from opioids
Measured: 1 month from participant's enrollment
Sustained Abstinence - Phase 2 RCT (Month 3)
Proportion of participants with sustained abstinence (composite of biochemical \& self-report data) from opioids
Measured: 3 months from participant's enrollment
Sustained Abstinence - Phase 2 RCT (Month 6)
Proportion of participants with sustained abstinence (composite of biochemical \& self-report data) from opioids
Measured: 6 months from participant's enrollment
Longest Duration of Abstinence - Phase 2 RCT (Month 1)
Longest duration of consecutive days of abstinence (composite of biochemical \& self-report data)
Measured: 1 month from participant's enrollment
Longest Duration of Abstinence - Phase 2 RCT (Month 3)
Longest duration of consecutive days of abstinence (composite of biochemical \& self-report data)
Measured: 3 months from participant's enrollment
Longest Duration of Abstinence - Phase 2 RCT (Month 6)
Longest duration of consecutive days of abstinence (composite of biochemical \& self-report data)
Measured: 6 months from participant's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start18 Nov 2022
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Enrollment was impacted by a massive epidemiological shift that led to reduced rates of presentation to the ED for opioid overdose. Despite more than a year of adjusting protocols and site expansion, we were not able to meet study enrollment goals.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups will be enrolled at the same time through, with group designated by randomization, and monitored through the 12-week RCT as well as follow ups at 1-, 3-, and 6-months post enrollment.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Q2i, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Rachel Davis-Martin, PhD, Study director, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180669
- Sponsor's protocol ID
- H00017879-2
- Other IDs
- R42DA049448
- Acronym
- OARSCM
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2021
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all individual participant data (IPD) that underlie published results.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 2
- ClinicalTrials.gov ID
- NCT05180669
- Acronym / sponsor ID
- OARSCM / H00017879-2
- Conditions
- Opioid Use Disorder
- Keywords
- Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was impacted by a massive epidemiological shift that led to reduced rates of presentation to the ED for opioid overdose. Despite more than a year of adjusting protocols and site expansion, we were not able to meet study enrollment goals.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Q2i, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester, National Institute on Drug Abuse (NIDA)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This project will utilize a digital mobile platform, Opioid Addiction Recovery Support with contingency management (OARSCM), to increase MAT treatment initiation and adherence among OUD patients recruited from emergency departments and inpatient acute care.
Detailed description
Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests and are highly efficacious. An OARS solution enhanced with a CM component (OARSCM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARSCM using patient-centered design principles. Focus groups with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined, and the program iteratively updated. After meeting milestones, there was a proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers. After meeting milestones, this RCT will follow, in which acute care OUD patients appropriate for outpatient Suboxone (N = 102) are recruited and allocated to one of two study conditions: 1) treatment as usual (TAU) with MyMAT, comprised of screening, brief intervention, referral to treatment by a trained clinician, and an educational mobile app (MyMAT), 2) OARSCM. The active intervention window for the two intervention groups will be 12 weeks. Patients will be onboarded prior to discharge from acute care. In the outpatient Suboxone setting, data on treatment adherence and opioid use will be captured from clinical records for six months. Telephone follow-up assessments and vital statics registry reviews will be at month 1, month 3 (end-of-study intervention period), and month 6. Primary Suboxone treatment initiation outcomes will be completing the Suboxone intake. Primary Suboxone treatment outcomes will be sustained abstinence at Month 6 and longest duration of abstinence. Analysis will examine data on cost avoidance and cost savings through reduced acute care visits between study conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both groups will be enrolled at the same time through, with group designated by randomization, and monitored through the 12-week RCT as well as follow ups at 1-, 3-, and 6-months post enrollment.
| Arm | Type | Receives |
|---|---|---|
| OARSCM | Experimental | Other: OARSCM Software ApplicationOARSCM (n = 21) patients will receive the same TAU procedures described above. They will also earn chances for prizes, with the same targeted behaviors, escalation of chances for prizes for each targeted behavior in a row, and reset criteria described. Briefly, for scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with documentation of each targeted behavior in a row up to a maximum of 10 draws/targeted behavior. With 38 targeted behaviors (schedule MOUD intake, complete intake, 12 opioid-negative urine toxicology/week over 12 weeks plus bonuses for cocaine-negative tests, and 12 group/individual therapy/week over 12 weeks), patients can earn up to 252 chances for prizes during the 12-week RCT. |
| TAU with MyMAT | Sham comparator | Other: MyMAT Software ApplicationTAU (n = 20) In the acute care setting, the Behavioral Health Service provides SBIRT for substance use disorders, including OUD. They provide SBIRT as part of TAU, including a warm handoff to an outpatient MOUD treatment with a scheduled outpatient appointment, optimally within 48 hours of the ED visit. TAU outpatient suboxone treatment consists of urine toxicology screening, group/individual therapy, and MOUD prescription continent on drug-negative urine toxicology. Treatment visits are typically weekly in weeks 1-4 and then taper over time, to every other week in weeks 5-8, and monthly in weeks 9-12 and after. Nonadherence can lead to increased frequency/intensity of therapy and urine toxicology until the patient stabilizes. If increased frequency/intensity is unsuccessful, patients may be referred to detoxification and subsequently re-admitted to outpatient care when appropriate. Patients will receive MyMAT a mobile application with educational content regarding MOUD treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 18 years old
- Presenting for acute care at UMass University and Memorial hospitals, including EDs, inpatient medical units, or inpatient behavioral health units for opioid addiction related health complaints, including opioid overdose, opioid related medical consequences, opioid intoxication or withdrawal syndromes, and/or seeking help for OUD
- Presence of a current DSM-V opioid use disorder (OUD), mild to severe
- Medically appropriate for outpatient Suboxone treatment, as judged by the treating clinician and behavioral health consultant or toxicologist working with the patient clinically
Key exclusion criteria (10 listed)
- Persistent altered mental status (not alert, not oriented, psychotic).
- Not interested or willing to participate in Suboxone treatment
- Best referral site is NOT one of the study's partner clinics in the central MA region, which will be outpatient MAT clinics and primary care within the UMass system and the three other primary facilities outside of the UMass system.
- Unwilling to use the OARSCM app (if assigned)
- Does not have access to their own smartphone with at least iOS 7.1 or Android 4.2, the minimal technology required to run the app, or not willing to access clinic-dedicated computer to access the program
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 |
|---|---|---|
| OARSCM Software ApplicationAlso: Opioid Addiction Recovery Support - Contingency Management (OARSCM)Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals. | Other | OARSCM |
| MyMAT Software ApplicationAlso: MyMATAccess is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment. | Other | TAU with MyMAT |
Primary outcome
Percent Outpatient Intake Scheduled - Phase 2 RCT
Time frame: 1 timepoint - Before patients are discharged from acute care at the time of study enrollment
Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care
Percent Outpatient Intakes Completed - Phase 2 RCT
Time frame: Typically, within ~48 hours of discharge from acute care
Percentage of patients who complete their outpatient Suboxone intake
6 secondary outcomes
Sustained Abstinence - Phase 2 RCT (Month 1)
Time frame: 1 month from participant's enrollment
Sustained Abstinence - Phase 2 RCT (Month 3)
Time frame: 3 months from participant's enrollment
Sustained Abstinence - Phase 2 RCT (Month 6)
Time frame: 6 months from participant's enrollment
Longest Duration of Abstinence - Phase 2 RCT (Month 1)
Time frame: 1 month from participant's enrollment
Longest Duration of Abstinence - Phase 2 RCT (Month 3)
Time frame: 3 months from participant's enrollment
Longest Duration of Abstinence - Phase 2 RCT (Month 6)
Time frame: 6 months from participant's enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Webpage for OARSCM solutionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share all individual participant data (IPD) that underlie published results.
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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.
Rachel Davis-Martin, PhD study director
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OARSCM Software Application and MyMAT Software Application 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Feb 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. Some participants in this study may receive a placebo. 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 Feb 2026). 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?
Percent Outpatient Intake Scheduled - Phase 2 RCT (time frame: 1 timepoint - Before patients are discharged from acute care at the time of study enrollment). 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 Feb 2026.