Improving Office Based Treatment of Opioid Use Disorder With Technology

NCT ID: NCT03586466

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-09-30

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.

Detailed Description

The misuse and abuse of opioids is a serious public health problem. SAMHSA estimates that more than 12 million Americans misuse prescription opioids for nonmedical purposes annually. The costs of this problem are substantial, both to individuals and society: total costs of prescription opioid misuse, abuse, and overdose to the US is estimated at $78.5 billion annually. Additionally, the prevalence of opioid abuse and associated costs are on the rise. In spite of this, the availability and acceptance of treatment with medications has not kept pace with the spread of the epidemic.

Prescription of buprenorphine/naloxone (B/N) is intended to address a behavioral health issue (misuse of opioids) as a component of Medication Assisted Treatment (MAT) for those who are pharmacologically dependent on opioids. In chronic illness, patient compliance and adherence with a prescribed regimen has been shown to correlate with treatment success, and conversely poor patient compliance, commonly documented, correlates with poor outcomes. Studies have demonstrated that with B/N specifically, compliance is predictive of both relapse and treatment retention. Relapse events are costly in terms of total healthcare expenditures (around $15,000 per patient), and personally - upwards of 800,000 years of potential life lost before the age of 65 in the US alone.

This study seeks to examine the effectiveness of MedicaSafe's BupreCare system in the delivery of MAT to those with OUD. The BupreCare system is a connected, locking, oral medication dispenser and secure pill cartridges coupled with an online platform. The system is programmed with a treatment plan to allow for the dispensation of medications in the right dose at the right time. Dispensation is recorded and collated in treatment reports to track patient adherence to their regimen. The project intends to ameliorate issues associated with MAT by curbing the negative effects of medication nonadherence and diversion, while simultaneously increasing provider awareness of patient behaviors and needs.

Patients aged 18-65 (inclusive) will be enrolled at Friends Research Institute in a field trial. Patients will be maintained on a stable dose of B/N, and randomized into one of three arms (BupreCare, TAU, or TAU with MEMS tracking). Subjects will have bi-weekly study visits over the course of 12 weeks. Assessments will be collected at baseline, and then every 2 weeks following study initiation.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BupreCare

Intervention Type: 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.

Buprenorphine/naloxone

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Buprenorphine/naloxone

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Buprenorphine/naloxone

Intervention Type: DRUG

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

MEMS

Intervention Type: OTHER

Subjects will receive their medication in a MEMS pill bottle.

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.

Intervention Type: DEVICE

Buprenorphine/naloxone

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

Intervention Type: DRUG

MEMS

Subjects will receive their medication in a MEMS pill bottle.

Intervention Type: OTHER

Other Intervention Names

MedicaSafe device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Friends Research Institute, Inc.

OTHER

Sponsor Role: collaborator

MedicaSafe, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anand Mattai, MD

Role: PRINCIPAL_INVESTIGATOR

MedicaSafe, Inc.

Locations

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status: TERMINATED

Friends Research Institute

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Caitlin Kelliher

Role: CONTACT

caitlin.kelliher@medicasafe.com

6466611092

Facility Contacts

Kathy Couvillion, BA

Role: primary

kcouvillion@friendsresearch.org

410-837-3977 ext. 242

Other Identifiers

Pro00023570

Identifier Type: -

Identifier Source: org_study_id