Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R42DA049448 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Enrollment was impacted by a massive epidemiological shift that led to reduced rates of presentation to the ED for opioid overdose. Despite more than a year of adjusting protocols and site expansion, we were not able to meet study enrollment goals.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Massachusetts, Worcester | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OARSCM | Experimental | OARSCM (n = 21) 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. |
|
| TAU with MyMAT | Sham Comparator | TAU (n = 20) 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OARSCM Software Application | Other | Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sustained Abstinence - Phase 2 RCT (Month 3) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Davis-Martin, PhD | University of Massachusetts, Worcester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | United States |
Not provided
| Label | URL |
|---|---|
| Webpage for OARSCM solution | View source |
Not provided
We plan to share all individual participant data (IPD) that underlie published results.
Data will be available starting 6 months after publication of results.
Deidentified data will be accessible to researchers who wish to conduct analyses not reported in prior publications. The study principal investigator will review any request for data to ensure no overlapping analyses. Deidentified data will be shared via secure, HIPAA-compliant data transfers.
Not provided
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).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OARSCM | OARSCM (n = 21) 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. OARSCM Software Application: Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals. |
| FG001 | TAU With MyMAT | TAU (n = 20) 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: Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OARSCM | 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. OARSCM Software Application: Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Outpatient Intake Scheduled - Phase 2 RCT | Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care | All enrolled participants were included. | Posted | Count of Participants | Participants | 1 timepoint - Before patients are discharged from acute care at the time of study enrollment |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OARSCM | 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. OARSCM Software Application: Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals. |
Not provided
Not provided
Low enrollment and lack of subject response to follow-up interviews led to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Jenkins, CEO | Q2i, LLC | 646-660-2151 | sjenkins@q2i-group.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2019 | Jan 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2019 | Jan 20, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| MyMAT Software Application | Other | Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment. |
|
|
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
| 3 months from participant's enrollment |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | TAU With MyMAT | 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: Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | TAU With MyMAT | TAU (n = 20) 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: Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment. |
|
|
|
| Primary | Percent Outpatient Intakes Completed - Phase 2 RCT | Percentage of patients who complete their outpatient Suboxone intake | All enrolled participants were included. | Posted | Count of Participants | Participants | Typically, within ~48 hours of discharge from acute care |
|
|
|
|
| Secondary | Sustained Abstinence - Phase 2 RCT (Month 1) | Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids | Participants who did not answer the follow-up call were considered lost to follow-up and assigned the worse possible outcome (i.e., yes, participant used opioids in past 30 days). Two OARSCM participants, one of which terminated the interview before completion, and zero TAU with MyMAT participants did the 1-month follow-up interview. | Posted | Count of Participants | Participants | 1 month from participant's enrollment |
|
|
|
| Secondary | Sustained Abstinence - Phase 2 RCT (Month 3) | Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids | Participants who did not answer the follow-up call were considered lost follow-up and assigned the worse possible outcome (i.e., yes, participant used opioids in past 30 days). One OARSCM participant and zero TAU with MyMAT participants did the 3-month follow-up interview. | Posted | Count of Participants | Participants | 3 months from participant's enrollment |
|
|
|
| Secondary | Sustained Abstinence - Phase 2 RCT (Month 6) | Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids | Participants who did not answer the follow-up call were considered lost follow-up and assigned the worse possible outcome (i.e., yes, participant used opioids in past 30 days). Zero participants from both arms did the 6-month follow-up interview. | Posted | 6 months from participant's enrollment |
|
|
|
| Secondary | Longest Duration of Abstinence - Phase 2 RCT (Month 1) | Longest duration of consecutive days of abstinence (composite of biochemical & self-report data) | Participants who did not answer the follow-up call were considered lost to follow-up and assigned the worse possible outcome (i.e., daily opioid use for past 30 days). Two OARSCM participants, one of which terminated the interview before completion, and zero TAU with MyMAT participants did the 1-month follow-up interview. | Posted | Mean | Standard Deviation | Days | 1 month from participant's enrollment |
|
|
|
| Secondary | Longest Duration of Abstinence - Phase 2 RCT (Month 3) | Longest duration of consecutive days of abstinence (composite of biochemical & self-report data) | Participants who did not answer the follow-up call were considered lost to follow-up and assigned the worse possible outcome (i.e., daily opioid use for past 30 days). One OARSCM participant and zero TAU with MyMAT participants did the 3-month follow-up interview. | Posted | Mean | Standard Deviation | Days | 3 months from participant's enrollment |
|
|
|
|
| Secondary | Longest Duration of Abstinence - Phase 2 RCT (Month 6) | Longest duration of consecutive days of abstinence (composite of biochemical & self-report data) | Participants who did not answer the follow-up call were considered lost to follow-up and assigned the worse possible outcome (i.e., daily opioid use for past 30 days). Zero participants from both arms did the 6-month follow-up interview. | Posted | 6 months from participant's enrollment |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | TAU With MyMAT | 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: Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided