Reward-based Technology to Improve OUD Treatment

Opioid Use Disorder Clinical Trial

— OARSCM  

Official title:

Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180669
• Other study ID #: H00017879-2
• Secondary ID: R42DA049448
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2023
• Source: Q2i, LLC
• Contact: Steven P Jenkins, BA
• Phone: 646-660-2151
• Email: sjenkins[@]q2i-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. >= 18 years old

2. 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

3. Presence of a current DSM-V opioid use disorder (OUD), mild to severe

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

Exclusion Criteria:

1. Persistent altered mental status (not alert, not oriented, psychotic).

2. Not interested or willing to participate in Suboxone treatment

3. 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.

4. Unwilling to use the OARSCM app (if assigned)

5. 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

6. Currently in state custody or pending legal action that might lead to imprisonment

7. Cannot paraphrase the study requirements

8. Does not read or speak English

9. Does not reside in the central MA region

10. Already enrolled into the trial

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Other:
• OARSCM Software Application
Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
• MyMAT Software Application
Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment.

Locations

Country	Name	City	State
United States	UMass Chan Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Q2i, LLC	National Institute on Drug Abuse (NIDA), University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent outpatient intake scheduled - Phase 2 RCT	Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care	1 timepoint - Before patients are discharged from acute care at the time of study enrollment
Primary	Percent outpatient intakes completed - Phase 2 RCT	Percentage of patients who complete their outpatient Suboxone intake	Typically, within ~48 hours of discharge from acute care
Primary	Sustained abstinence - Phase 2 RCT (Month 1)	Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids	1 month from participant's enrollment
Primary	Sustained abstinence - Phase 2 RCT (Month 3)	Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids	3 months from participant's enrollment
Primary	Sustained abstinence - Phase 2 RCT (Month 6)	Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids	6 months from participant's enrollment
Primary	Longest duration of abstinence - Phase 2 RCT (Month 1)	Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)	1 month from participant's enrollment
Primary	Longest duration of abstinence - Phase 2 RCT (Month 3)	Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)	3 months from participant's enrollment
Primary	Longest duration of abstinence - Phase 2 RCT (Month 6)	Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)	6 months from participant's enrollment

External Links

•   Webpage for OARSCM solution