Reward-based Technology for Opioid Use Disorder

(OARSCM Trial)

Overseen By Edwin D Boudreaux, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Q2i, LLC

Must be taking: Suboxone

Disqualifiers: Altered mental status, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

102 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on starting and adhering to Suboxone treatment for opioid use disorder.

What data supports the effectiveness of the treatment MyMAT Software Application for opioid use disorder?

Research shows that digital tools like mobile apps can help people understand and stick to medication-assisted treatment (MAT) for opioid use disorder. A study on a similar app, 'uMAT-R', found it could improve knowledge about recovery and the benefits of MAT, which are common barriers to starting treatment. ^{1 2 3 4 5}

Is the reward-based technology for opioid use disorder safe for humans?

The available research does not provide specific safety data for the reward-based technology for opioid use disorder, but similar digital therapeutic tools have been evaluated for their safety and efficacy in clinical trials. ^{1 5 6 7 8}

How is the MyMAT and OARSCM Software Application treatment different from other treatments for opioid use disorder?

The MyMAT and OARSCM Software Application treatment is unique because it uses a digital platform to provide reward-based support and motivational coaching, which can help improve adherence to medication-assisted treatment (MAT) and reduce opioid misuse. This approach is different from traditional treatments as it integrates technology to offer real-time interventions and support, making it more accessible and potentially more engaging for patients. ^{1 4 5 6 9}

Research Team

Rachel Davis-Martin, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Eligibility Criteria

Adults over 18 with opioid use disorder seeking acute care at UMass hospitals, diagnosed with OUD and suitable for outpatient Suboxone treatment. Excluded if they lack a compatible smartphone or access to the app, are not in central MA region, have legal issues that may lead to imprisonment, can't understand study requirements, don't speak English, already in the trial or unwilling to participate.

Inclusion Criteria

Medically appropriate for outpatient Suboxone treatment, as judged by the treating clinician and behavioral health consultant or toxicologist working with the patient clinically

I am 18 years old or older.

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

Exclusion Criteria

Already enrolled into the trial

I am not interested in 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Suboxone treatment with contingency management interventions for 12 weeks

12 weeks

Weekly visits in weeks 1-4, bi-weekly in weeks 5-8, monthly in weeks 9-12

Follow-up

Participants are monitored for treatment adherence and opioid use through clinical records and telephone assessments

6 months

Telephone follow-up at month 1, month 3, and month 6

Open-label extension (optional)

Participants may continue to receive treatment and monitoring beyond the initial study period

Long-term

Treatment Details

Interventions

• MyMAT Software Application
• OARSCM Software Application

Trial Overview The trial tests two software applications designed to improve adherence to Suboxone treatment for OUD patients. One group uses MyMAT (education app plus usual care), while the other uses OARSCM (enhanced with reward system). The study compares initiation and adherence rates over a 12-week active intervention period followed by six months of data collection.

Participant Groups

Group I: OARSCM Experimental Treatment 1 Intervention

OARSCM (n = 51) 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.

Group II: TAU with MyMAT Placebo Group 1 Intervention

TAU (n = 51) 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.

MyMAT Software Application is already approved in United States for the following indications:

Approved in United States as MyMAT Software Application for:

• Opioid use disorder treatment support

Who Is Running the Clinical Trial?

Q2i, LLC

Lead Sponsor

Trials

4

Recruited

370+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Massachusetts Chan Medical School

Collaborator

Trials

3

Recruited

1,100+

Findings from Research

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

The study developed new methods for recruiting and collecting survey data from a national sample of patients receiving buprenorphine medication-assisted treatment (B-MAT), highlighting the feasibility of researching this treatment approach outside of specialty facilities.

A telephonic support program for new B-MAT patients was found to be an acceptable adjunct to treatment, suggesting that additional support can enhance the treatment experience for opioid-dependent patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national study of a telephone support service for patients receiving office-based buprenorphine medication-assisted treatment: study feasibility and sample description. Ruetsch, C., Cacciola, J., Tkacz, J.[2013]

The PCSS-MAT initiative aims to enhance the treatment of opioid use disorders (OUD) by training health professionals in evidence-based pharmacological strategies, particularly focusing on the prescription of buprenorphine.

This ongoing national initiative, funded by SAMHSA, not only trains primary care physicians but also creates resources for families and communities, ultimately increasing access to effective treatment for OUD as a public health priority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of a national training initiative to increase provider use of MAT to address the opioid epidemic. Levin, FR., Bisaga, A., Sullivan, MA., et al.[2022]

The MySafeRx mobile platform, which combines electronic pill dispensers and motivational coaching, was found to be feasible and acceptable for improving medication adherence among high-risk young adults with opioid use disorder, with two-thirds of participants achieving over 5 days of supervised self-administration of buprenorphine/naloxone during a 28-day study.

Participants showed a 53% increase in illicit opioid abstinence rates during the intervention, but these gains were not sustained after the program ended, indicating a need for longer-term support to maintain treatment benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Schuman-Olivier, Z., Borodovsky, JT., Steinkamp, J., et al.[2019]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The Recovery Line, a computer-based intervention using cognitive behavioral therapy, showed promise in assisting patients on methadone maintenance, but actual usage was lower than recommended, highlighting the need for improved patient engagement strategies.

In two randomized trials involving 127 participants, customized recommendations improved usability ratings, and shorter reminder message latencies initially increased call frequency, particularly among males, suggesting that tailored approaches can enhance engagement with digital health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. Moore, BA., Buono, FD., Printz, DMB., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A national study of a telephone support service for patients receiving office-based buprenorphine medication-assisted treatment: study feasibility and sample description. [2013]

3. England pubmed.ncbi.nlm.nih.gov

A review of a national training initiative to increase provider use of MAT to address the opioid epidemic. [2022]

4. England pubmed.ncbi.nlm.nih.gov

MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. [2021]