Improving Office Based Treatment of Opioid Use Disorder With Technology

NCT03586466 | Unknown FDA Device

• 1 other identifier: Pro00023570
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Compliance

  Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.

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

Secondary Outcomes (2)

• Urine Drug Screens

  Bi-weekly, across the 12-week participation period.

• Relapse

  Examined bi-weekly across the 12-week participation period.

Other Outcomes (2)

• Compliance - Week 4

  Week 4 of the 12-week participation period.

• Compliance - Week 8

  Week 8 of the 12-week participation period.

Study Arms (3)

BupreCare

EXPERIMENTAL

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.

Device: BupreCare; Drug: Buprenorphine/naloxone

Treatment as Usual

ACTIVE COMPARATOR

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.

Drug: Buprenorphine/naloxone

Treatment as Usual with MEMS

ACTIVE COMPARATOR

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.

Drug: Buprenorphine/naloxone; Other: MEMS

Interventions

BupreCare DEVICE

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.

Also known as: MedicaSafe device

BupreCare

Buprenorphine/naloxone DRUG

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

BupreCare; Treatment as Usual; Treatment as Usual with MEMS

MEMS OTHER

Subjects will receive their medication in a MEMS pill bottle.

Treatment as Usual with MEMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedicaSafe, Inc.: lead
• Friends Research Institute, Inc.: collaborator

Study Sites (2)

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

TERMINATED

Friends Research Institute

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Micro-Electrical-Mechanical Systems

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Electrical Equipment and Supplies; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Anand Mattai, MD

  MedicaSafe, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Kelliher

CONTACT

6466611092; caitlin.kelliher@medicasafe.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: December 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

US (2)