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Trial record 98 of 189 for:    BUPRENORPHINE AND NALOXONE

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 : July 19, 2019
Sponsor:
Collaborator:
Friends Research Institute, Inc.
Information provided by (Responsible Party):
MedicaSafe, Inc.

Tracking Information
First Submitted Date  ICMJE July 2, 2018
First Posted Date  ICMJE July 13, 2018
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03586466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • 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.
  • Relapse [ Time Frame: Examined bi-weekly across the 12-week participation period. ]
    This will be determined by opiate-positive Urine Drug Screens.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 2, 2018)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Office Based Treatment of Opioid Use Disorder With Technology
Official Title  ICMJE Pilot for Improved Office Based Treatment of Opioid-Dependence
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE
  • 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).
  • Other: MEMS
    Subjects will receive their medication in a MEMS pill bottle.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: BupreCare
    • Drug: Buprenorphine/naloxone
  • 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.
    Intervention: Drug: Buprenorphine/naloxone
  • 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:
    • Drug: Buprenorphine/naloxone
    • Other: MEMS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Caitlin Kelliher 6466611092 caitlin.kelliher@medicasafe.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03586466
Other Study ID Numbers  ICMJE Pro00023570
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedicaSafe, Inc.
Study Sponsor  ICMJE MedicaSafe, Inc.
Collaborators  ICMJE Friends Research Institute, Inc.
Investigators  ICMJE
Principal Investigator: Anand Mattai, MD MedicaSafe, Inc.
PRS Account MedicaSafe, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP