Opioid Use Disorder
Conditions
Keywords
Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment
Brief 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. 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.
Interventions
Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment.
Sponsors
Study design
Intervention 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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Outpatient Intake Scheduled - Phase 2 RCT | 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 | Typically, within ~48 hours of discharge from acute care | Percentage of patients who complete their outpatient Suboxone intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Abstinence - Phase 2 RCT (Month 1) | 1 month from participant's enrollment | Proportion of participants with sustained abstinence (composite of biochemical \& self-report data) from opioids |
| Sustained Abstinence - Phase 2 RCT (Month 3) | 3 months from participant's enrollment | Proportion of participants with sustained abstinence (composite of biochemical \& self-report data) from opioids |
| Sustained Abstinence - Phase 2 RCT (Month 6) | 6 months from participant's enrollment | Proportion of participants with sustained abstinence (composite of biochemical \& self-report data) from opioids |
| Longest Duration of Abstinence - Phase 2 RCT (Month 1) | 1 month from participant's enrollment | Longest duration of consecutive days of abstinence (composite of biochemical \& self-report data) |
| Longest Duration of Abstinence - Phase 2 RCT (Month 3) | 3 months from participant's enrollment | Longest duration of consecutive days of abstinence (composite of biochemical \& self-report data) |
| Longest Duration of Abstinence - Phase 2 RCT (Month 6) | 6 months from participant's enrollment | Longest duration of consecutive days of abstinence (composite of biochemical \& self-report data) |
Countries
United States
Contacts
University of Massachusetts Chan Medical School
Participant flow
Recruitment details
Individuals with OUD presenting to an acute care setting were approached to participate in the study between August 2022 and September 2024. Those who met the eligibility criteria and confirmed their interest in participating in the study were enrolled. The first participant was enrolled November 18, 2022 and the last patient was enrolled July 9, 2024.
Pre-assignment details
Of the 3,006 individuals with OUD who were approached, 84 were eligible and 41 agreed to participate in the study. These 41 participants were then randomized to OARSCM (21 participants) or TAU MyMAT (20 participants).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |