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Improving Office Based Treatment of Opioid Use Disorder With Technology

NCT03586466 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-07-19

No results posted yet for this study

Summary

The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.

Conditions

  • Opioid-use Disorder

Interventions

DEVICE

BupreCare

Subjects will receive their medication in a MedicaSafe device. Medication will be dispensed in accordance with the programmed treatment plan for each subject. Subjects will complete a "Check-In" remotely each week with their device.

DRUG

Buprenorphine/naloxone

Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).

OTHER

MEMS

Subjects will receive their medication in a MEMS pill bottle.

Sponsors & Collaborators

  • Friends Research Institute, Inc.

    collaborator OTHER

  • MedicaSafe, Inc.

    lead INDUSTRY

Principal Investigators

  • Anand Mattai, MD · MedicaSafe, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-09-30
Completion
2020-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03586466 on ClinicalTrials.gov