Reward-based Technology to Improve OUD Treatment

NCT05180669 | Terminated Results

• 2 other identifiers: H00017879-2R42DA049448
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Substance Use Disorder; Opioid Use Disorder; Contingency Management; Medication for opioid use disorder; Medication-assisted treatment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Sustained Abstinence - Phase 2 RCT (Month 1)

  1 month from participant's enrollment

• Sustained Abstinence - Phase 2 RCT (Month 3)

  3 months from participant's enrollment

• Sustained Abstinence - Phase 2 RCT (Month 6)

  6 months from participant's enrollment

• Longest Duration of Abstinence - Phase 2 RCT (Month 1)

  1 month from participant's enrollment

• Longest Duration of Abstinence - Phase 2 RCT (Month 3)

  3 months from participant's enrollment

Study Arms (2)

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.

Other: OARSCM Software Application

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.

Other: MyMAT Software Application

Interventions

OARSCM Software Application OTHER

Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.

Also known as: Opioid Addiction Recovery Support - Contingency Management (OARSCM)

OARSCM

MyMAT Software Application OTHER

Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment.

Also known as: MyMAT

TAU with MyMAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Q2i, LLC: lead
• University of Massachusetts, Worcester: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Links

• Webpage for OARSCM solution

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Low enrollment and lack of subject response to follow-up interviews led to small numbers of subjects analyzed.

Results Point of Contact

• Title: Steven Jenkins, CEO
• Organization: Q2i, LLC

sjenkins@q2i-group.com

646-660-2151

Study Officials

• Rachel Davis-Martin, PhD

  University of Massachusetts Chan Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: January 6, 2022
• Study Start: November 18, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available starting 6 months after publication of results.
• 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.

Locations

US (1)