41 Participants Needed

Reward-based Technology for Opioid Use Disorder

(OARSCM Trial)

SP
ED
Overseen ByEdwin D Boudreaux, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Q2i, LLC
Must be taking: Suboxone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

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.12345

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.14567

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.45789

Who Is on the Research Team?

RD

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.
See 6 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OARSCMExperimental Treatment1 Intervention
Group II: TAU with MyMATPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as MyMAT Software Application for:

Find a Clinic Near You

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 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.
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.
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.
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]

Citations

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]
A national study of a telephone support service for patients receiving office-based buprenorphine medication-assisted treatment: study feasibility and sample description. [2013]
A review of a national training initiative to increase provider use of MAT to address the opioid epidemic. [2022]
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]
Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]
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]
Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]
Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]
Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. [2021]
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