Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05180669
Study type Interventional
Source Q2i, LLC
Contact Steven P Jenkins, BA
Phone 646-660-2151
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 15, 2022
Completion date January 15, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT02559973 - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder Phase 1
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02440256 - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial N/A
Recruiting NCT05180487 - Parenting Young Children Study N/A
Suspended NCT04577144 - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery-Long Term
Completed NCT03033732 - A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse Phase 4
Recruiting NCT05086835 - A Mobile Executive Functioning Intervention for Momentary Craving in Opioid Use Disorders N/A
Recruiting NCT03821337 - Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning N/A
Recruiting NCT05027919 - Assessing a Clinically-meaningful Opioid Withdrawal Phenotype Phase 2
Recruiting NCT05062577 - A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder Phase 2
Recruiting NCT05143424 - Evaluation of the Interactions of Cannabidiol (CBD) With Morphine Phase 1
Recruiting NCT04375033 - A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder Phase 4
Recruiting NCT04916600 - NET Device for Treating Opioid Use Disorder N/A
Completed NCT02942199 - MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE) N/A
Completed NCT02672111 - Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder Phase 3
Completed NCT02044094 - Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder Phase 2
Completed NCT02765867 - Single-dose, Study of RBP-6000 in Opioid Dependent Individuals Phase 1
Completed NCT05127707 - Strategies to Reduce Addiction Stigma Among Health Professionals N/A
Recruiting NCT04567784 - Neuroimaging and CBD for Heroin Use Disorder Phase 2