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Reward-based Technology for Opioid Use Disorder (OARSCM Trial)

N/A
Recruiting
Research Sponsored by Q2i, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from participant's enrollment
Awards & highlights

OARSCM Trial Summary

This trial is designed to increase rates of Suboxone treatment initiation and adherence among opioid use disorder patients recruited from emergency and inpatient acute care by enhancing an existing technology with a new evidence-based reward, contingency management function.

Who is the study for?
Adults over 18 with opioid use disorder seeking acute care at UMass hospitals, diagnosed with OUD and suitable for outpatient Suboxone treatment. Excluded if they lack a compatible smartphone or access to the app, are not in central MA region, have legal issues that may lead to imprisonment, can't understand study requirements, don't speak English, already in the trial or unwilling to participate.Check my eligibility
What is being tested?
The trial tests two software applications designed to improve adherence to Suboxone treatment for OUD patients. One group uses MyMAT (education app plus usual care), while the other uses OARSCM (enhanced with reward system). The study compares initiation and adherence rates over a 12-week active intervention period followed by six months of data collection.See study design
What are the potential side effects?
Since this trial involves software applications aimed at improving treatment adherence rather than medications or medical procedures directly administered to participants, traditional side effects are not applicable. However, users may experience technical issues or stress related to using digital technology.

OARSCM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

OARSCM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months from participant's enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from participant's enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Longest duration of abstinence - Phase 2 RCT (Month 1)
Longest duration of abstinence - Phase 2 RCT (Month 3)
Longest duration of abstinence - Phase 2 RCT (Month 6)
+5 more

OARSCM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OARSCMExperimental Treatment1 Intervention
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.
Group II: TAU with MyMATPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Q2i, LLCLead Sponsor
3 Previous Clinical Trials
271 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
342 Previous Clinical Trials
977,048 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,862 Total Patients Enrolled

Media Library

MyMAT Software Application Clinical Trial Eligibility Overview. Trial Name: NCT05180669 — N/A
Opioid Use Disorder Research Study Groups: OARSCM, TAU with MyMAT
Opioid Use Disorder Clinical Trial 2023: MyMAT Software Application Highlights & Side Effects. Trial Name: NCT05180669 — N/A
MyMAT Software Application 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180669 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more volunteers needed for this trial?

"The most recent data from clinicaltrials.gov suggests that this study is still looking for volunteers. The original posting was on 8/22/2022, with the latest update being on 9/12/2022."

Answered by AI
~10 spots leftby May 2024