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Opioid Agonist
BupreCare for Opioid Use Disorder
N/A
Waitlist Available
Led By Anand Mattai, MD
Research Sponsored by MedicaSafe, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compliance checks will be done every 14 days. total compliance for each subject will be looked at across the 12-week period of participation.
Awards & highlights
Study Summary
This study is evaluating whether a new drug delivery system may help improve compliance and treatment outcomes for patients with opioid use disorder.
Eligible Conditions
- Opioid Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ compliance checks will be done every 14 days. total compliance for each subject will be looked at across the 12-week period of participation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compliance checks will be done every 14 days. total compliance for each subject will be looked at across the 12-week period of participation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compliance
Secondary outcome measures
Relapse
Urine Drug Screens
Other outcome measures
Compliance - Week 4
Compliance - Week 8
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: BupreCareExperimental Treatment2 Interventions
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 II: Treatment as UsualActive Control1 Intervention
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 III: Treatment as Usual with MEMSActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
FDA approved
Find a Location
Who is running the clinical trial?
MedicaSafe, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Friends Research Institute, Inc.OTHER
52 Previous Clinical Trials
20,528 Total Patients Enrolled
Anand Mattai, MDPrincipal InvestigatorMedicaSafe, Inc.
Frequently Asked Questions
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