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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital platform designed to help individuals with opioid use disorder (OUD) adhere to their medication treatment. It compares two approaches: one uses the MyMAT Software Application, which offers rewards for following treatment steps, and the other provides standard care with educational content. The trial aims to determine if rewards can improve treatment engagement and outcomes for those with OUD. Individuals who have experienced an opioid-related health issue and are seeking treatment may be suitable for this trial. Participants need access to a smartphone and must reside in central Massachusetts. As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment strategies for OUD.

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 prior data suggests that these software applications are safe for opioid use disorder treatment?

Research has shown that the OARSCM app, a mobile tool for managing treatment, is generally safe for people with opioid use disorder. Studies have found that this app improves treatment by rewarding positive actions, such as attending therapy or having drug-free tests.

The app tracks these actions and offers incentives, making it easier to follow treatment plans. No reports of serious safety issues or harmful side effects have emerged from using this app. It aims to support individuals in staying on track with their treatment.

For those considering joining a trial that uses this app, evidence suggests it is well-tolerated and can be a helpful tool for recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's testing innovative software applications to support people with opioid use disorder (OUD). Unlike traditional treatments that rely mainly on medication and therapy, the OARSCM software adds a reward-based system where patients earn chances for prizes by achieving certain behaviors, like attending appointments and having drug-free tests. This approach could motivate patients in new ways and potentially improve treatment adherence. Meanwhile, the MyMAT app provides educational content about OUD treatment, helping patients better understand and manage their care. By integrating technology with traditional treatment, this trial could lead to more effective ways to support recovery.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that reward-based technology, such as the OARSCM Software Application, can help treat opioid use disorder (OUD). Studies have found that providing rewards for positive actions, known as contingency management, helps patients adhere to their medication-assisted treatment (MAT) plans. This increases the likelihood of patients following their treatment plans. Meanwhile, the MyMAT Software Application offers educational content to support OUD patients. Early results suggest that digital tools can facilitate the initiation and continuation of treatment for OUD patients. By encouraging positive behaviors, these applications aim to improve treatment outcomes and reduce opioid misuse. ^{2 3 4 6 7}

Who Is on the Research Team?

Rachel Davis-Martin, PhD

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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