Technology for MAT in Primary Care

Status Enrolling by invitation

Clinical Trial Summary

With over 72,000 overdose deaths in 2017, of which 47,600 are attributable to opioid overdose, the opioid epidemic has become North America's most widespread behavioral public health problem. Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious. The Opioid Addiction Recovery Support (OARS), comprised of a healthcare team portal connected to a patient mobile application, provides opioid-related education, promotes connectedness with clinicians, and tracks MAT treatment progress. This study will conduct interviews with patients that will inform optimal design of OARS, assess the efficacy of OARS in improving MAT outcomes in primary care settings, and evaluate the sustainability and return on investment. It joins an outstanding scientific team at University of California, Los Angeles and a small business that has developed, Opioid Addiction Recovery Support (OARS) -- a software platform that by integrating with the Electronic Health Record (EHR) improves clinical management of patients by primary care providers (PCPs) treating patients with OUD using MAT. OARS platform uses a dashboard to show the real-time measurement of patient achievements in recovery. It provides opportunities for patients to interact with their PCPs, allowing for better connection to and support from their PCPs. OARS platform features artificial intelligence to analyze information from the EHR and from patients to provide a relapse risk assessment for patients receiving MAT for OUD, an innovation that sets OARS apart from other software solutions. The goal of Phase 1 was to modify the OARS platform for use in primary care settings by conducting interviews with Primary Care Physicians (PCPs) (N=20) and their patients with OUD (N=40) in primary care settings to collect data on feasibility and acceptability of engaging with OARS to inform the user-centered design of OARS. The goals of Phase 2 of this study are to: (1) to assess the effectiveness of OARS in improving opioid agonist treatment outcomes across 6 treatment programs (N=200 treated patients) and (2) evaluate the sustainability and return on investment of OARS implementation across 6 treatment programs. A commercialization plan documents progress to date for the OARS platform and presents a market plan to improve both the scale and quality of MAT services delivered by PCPs in primary care, which is a major contribution to addressing the ongoing opioid epidemic.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05017272
Study type	Interventional
Source	Q2i, LLC
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	May 1, 2021
Completion date	August 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04157062` - An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder	N/A
Enrolling by invitation	`NCT04527926` - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy	N/A
Completed	`NCT04505540` - Start Treatment and Recovery for Opioid Use Disorder	N/A
Completed	`NCT03065049` - Transforming Recovery Through Exercise and Community	N/A
Completed	`NCT04080037` - Assessing Opioid Care Practices Using CPV Patient Simulation Modules	N/A
Recruiting	`NCT05118204` - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization	Phase 4
Suspended	`NCT05001789` - Cognitive Functioning in Opioid Use Disorder	N/A
Active, not recruiting	`NCT04650386` - Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients	N/A
Completed	`NCT03715634` - Study of a Novel Subcutaneous Depot Formulation of Buprenorphine	Phase 1
Enrolling by invitation	`NCT04991974` - Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine	Phase 2/Phase 3
Completed	`NCT04122755` - Single Ascending Dose Study of ALA-1000	Phase 1
Recruiting	`NCT04927143` - Encouraging Abstinence Behavior in a Drug Epidemic	Phase 2
Recruiting	`NCT05028998` - COVID-19-Related Opioid Treatment Policy Evaluation
Recruiting	`NCT05049460` - Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder	N/A
Completed	`NCT05047627` - Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder	N/A
Active, not recruiting	`NCT04129580` - reSET-O RCT (Randomized Controlled Trial)	N/A
Recruiting	`NCT03923374` - Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Completed	`NCT04056182` - Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment	Phase 2
Suspended	`NCT02687360` - Imaging the Effects of rTMS on Chronic Pain	N/A
Completed	`NCT03766893` - Medication Maintenance Therapy in Community Pharmacy Settings	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Technology for MAT in Primary Care - Phase 2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms