Improving Office Based Treatment of Opioid Use Disorder With Technology

• ClinicalTrials.gov Identifier: NCT03586466
• Recruitment Status: Recruiting
• First Posted: July 13, 2018
• Last Update Posted: July 19, 2019
• Sponsor: MedicaSafe, Inc.
• Collaborator: Friends Research Institute, Inc.
• Information provided by (Responsible Party): MedicaSafe, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder	Device: BupreCare; Drug: Buprenorphine/naloxone; Other: MEMS	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot for Improved Office Based Treatment of Opioid-Dependence
• Actual Study Start Date: December 1, 2018
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: September 2020

Arms and Interventions

Arm	Intervention/treatment
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.	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.; Other Name: MedicaSafe device; Drug: Buprenorphine/naloxone; Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
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.	Drug: Buprenorphine/naloxone; Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   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.

Secondary Outcome Measures :

1. Urine Drug Screens [ Time Frame: Bi-weekly, across the 12-week participation period. ]
   Urine Drug Tests will be given at each in-person study visit to test for opiates and other illicit substances. The proportion of negative urine samples (for opiates) will serve as a secondary endpoint.
2. Relapse [ Time Frame: Examined bi-weekly across the 12-week participation period. ]
   This will be determined by opiate-positive Urine Drug Screens.

Other Outcome Measures:

1. Compliance - Week 4 [ Time Frame: Week 4 of the 12-week participation period. ]
   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.
2. Compliance - Week 8 [ Time Frame: Week 8 of the 12-week participation period. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Caitlin Kelliher; 6466611092; caitlin.kelliher@medicasafe.com

Locations

United States, California

Artemis Institute for Clinical Research; Terminated

San Diego, California, United States, 92103

United States, Maryland

Friends Research Institute; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Kathy Couvillion, BA 410-837-3977 ext 242 kcouvillion@friendsresearch.org

Principal Investigator: Michael Gordon, DPA

Sponsors and Collaborators

MedicaSafe, Inc.

Friends Research Institute, Inc.

Investigators

• Principal Investigator: Anand Mattai, MD; MedicaSafe, Inc.

More Information

• Responsible Party: MedicaSafe, Inc.
• ClinicalTrials.gov Identifier: NCT03586466 History of Changes
• Other Study ID Numbers: Pro00023570
• First Posted: July 13, 2018
• Last Update Posted: July 19, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by MedicaSafe, Inc.:

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

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Narcotic Antagonists