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Reward-based Technology to Improve OUD Treatment (OARSCM)

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OARSCM Software Application
MyMAT Software Application
Sponsored by
Q2i, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMass Chan Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

OARSCM

TAU with MyMAT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent outpatient intake scheduled - Phase 2 RCT
Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care
Percent outpatient intakes completed - Phase 2 RCT
Percentage of patients who complete their outpatient Suboxone intake
Sustained abstinence - Phase 2 RCT (Month 1)
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
Sustained abstinence - Phase 2 RCT (Month 3)
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
Sustained abstinence - Phase 2 RCT (Month 6)
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
Longest duration of abstinence - Phase 2 RCT (Month 1)
Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)
Longest duration of abstinence - Phase 2 RCT (Month 3)
Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)
Longest duration of abstinence - Phase 2 RCT (Month 6)
Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)

Secondary Outcome Measures

Full Information

First Posted
October 20, 2021
Last Updated
May 25, 2023
Sponsor
Q2i, LLC
Collaborators
University of Massachusetts, Worcester, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05180669
Brief Title
Reward-based Technology to Improve OUD Treatment
Acronym
OARSCM
Official Title
Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Q2i, LLC
Collaborators
University of Massachusetts, Worcester, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Substance Use Disorder, Opioid Use Disorder, Contingency Management, Medication for opioid use disorder, Medication-assisted treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OARSCM
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU with MyMAT
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
OARSCM Software Application
Other Intervention Name(s)
Opioid Addiction Recovery Support - Contingency Management (OARSCM)
Intervention Description
Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.
Intervention Type
Other
Intervention Name(s)
MyMAT Software Application
Other Intervention Name(s)
MyMAT
Intervention Description
Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment.
Primary Outcome Measure Information:
Title
Percent outpatient intake scheduled - Phase 2 RCT
Description
Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care
Time Frame
1 timepoint - Before patients are discharged from acute care at the time of study enrollment
Title
Percent outpatient intakes completed - Phase 2 RCT
Description
Percentage of patients who complete their outpatient Suboxone intake
Time Frame
Typically, within ~48 hours of discharge from acute care
Title
Sustained abstinence - Phase 2 RCT (Month 1)
Description
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
Time Frame
1 month from participant's enrollment
Title
Sustained abstinence - Phase 2 RCT (Month 3)
Description
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
Time Frame
3 months from participant's enrollment
Title
Sustained abstinence - Phase 2 RCT (Month 6)
Description
Proportion of participants with sustained abstinence (composite of biochemical & self-report data) from opioids
Time Frame
6 months from participant's enrollment
Title
Longest duration of abstinence - Phase 2 RCT (Month 1)
Description
Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)
Time Frame
1 month from participant's enrollment
Title
Longest duration of abstinence - Phase 2 RCT (Month 3)
Description
Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)
Time Frame
3 months from participant's enrollment
Title
Longest duration of abstinence - Phase 2 RCT (Month 6)
Description
Longest duration of consecutive days of abstinence (composite of biochemical & self-report data)
Time Frame
6 months from participant's enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >= 18 years old 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 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: Persistent altered mental status (not alert, not oriented, psychotic). Not interested 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. Unwilling to use the OARSCM app (if assigned) 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 Currently in state custody or pending legal action that might lead to imprisonment Cannot paraphrase the study requirements Does not read or speak English Does not reside in the central MA region Already enrolled into the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven P Jenkins, BA
Phone
646-660-2151
Email
sjenkins@q2i-group.com
First Name & Middle Initial & Last Name or Official Title & Degree
Edwin D Boudreaux, PhD
Phone
508-334-3817
Email
Edwin.Boudreaux@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Davis-Martin, PhD
Organizational Affiliation
University of Massachusetts Chan Medical School
Official's Role
Study Director
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edwin D Boudreaux, PhD
Phone
508-334-3817
Email
Edwin.Boudreaux@umassmed.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share all individual participant data (IPD) that underlie published results.
IPD Sharing Time Frame
Data will be available starting 6 months after publication of results.
IPD Sharing Access Criteria
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.
Links:
URL
https://q2i.com/oars-cm/
Description
Webpage for OARSCM solution

Learn more about this trial

Reward-based Technology to Improve OUD Treatment

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