Recruiting

Observational Study

Sponsor:

MedicaSafe, Inc.

Code:

NCT03586466

Conditions

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BupreCare

Buprenorphine/naloxone

MEMS

Study Details

Brief 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

Study ID

NCT03586466

Start date

Dec 1, 2018

Status verified date

Jul, 2019

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be between the ages of 18 and 65 years old
  • Be able to provide informed consent
  • Be English-speaking
  • Have consistent phone and/or internet access
  • Deemed by physician as medically, psychiatrically, and otherwise appropriate for buprenorphine therapy
  • Maintained on a stable B/N dose

Exclusion Criteria:

  • Be younger than 18 or older than 65 years of age
  • Chronic pain
  • Be non-English speaking
  • Be unable to complete informed consent
  • Be pregnant

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BupreCare

The BupreCare system is an integrated medication management and patient monitoring system, consisting of a smart medication-tracking dispenser and online platform. The dispensing component is a portable smart dispenser and secure pill cartridges that is programmed with an individualized treatment plan for each patient. This arm will be assigned a MedicaSafe device that will have their buprenorphine/naloxone securely stored. Treatment reports of their dispensation history will be collated and available to the treatment team.

active comparator: Treatment as Usual

This arm represents an active comparator for the experimental group. Subjects in this group will undergo TAU, with no changes to the way that they receive their medication. They will have pill counts bi-weekly to examine adherence.

active comparator: Treatment as Usual with MEMS

This arm represents a second active comparator for the experimental group. Subjects in this group will receive their medication in a MEMS pill bottle, but otherwise will undergo TAU.

Interventions

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.

Buprenorphine/naloxone

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

MEMS

Subjects will receive their medication in a MEMS pill bottle.

Primary outcome measure

  • Compliance [ Time Frame: Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation. ]

Central Contacts and Locations

Central contacts

Caitlin Kelliher

6466611092caitlin.kelliher@medicasafe.com

Locations

Friends Research Institute

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kathy Couvillion, BA

410-837-3977kcouvillion@friendsresearch.org

Principal Investigator:

Michael Gordon, DPA

More Information

Sponsor

MedicaSafe, Inc.

Last update posted

Jul 19, 2019

Last verified

Jul, 2019

Keywords

  • opioid abuse
  • opioid dependence
  • medication assisted treatment
  • opioids
  • buprenorphine
  • buprenorphine/naloxone
  • MedicaSafe

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MedicaSafe, Inc. on 2019-07-19.