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Improving Office Based Treatment of Opioid Use Disorder With Technology

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ClinicalTrials.gov Identifier: NCT03586466
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Friends Research Institute, Inc.
Information provided by (Responsible Party):
MedicaSafe, Inc.

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 two partner sites (Total Health Care and Artemis 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.


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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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586466


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

Locations
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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
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Principal Investigator: Anand Mattai, MD MedicaSafe, Inc.

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Responsible Party: MedicaSafe, Inc.
ClinicalTrials.gov Identifier: NCT03586466     History of Changes
Other Study ID Numbers: Pro00023570
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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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:
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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