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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

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a new device called BupreCare that helps people with opioid addiction take their medication correctly. The device locks the pills and only gives the right amount at the right time, while also tracking when the medication is taken. This helps doctors monitor their patients and improve treatment outcomes. Buprenorphine is a medication approved in the United States for the treatment of opioid dependence, offering a safe and effective alternative for individuals with opioid addiction.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and compliance checks will be done every 14 days. total compliance for each subject will be looked at across the 12-week period of participation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compliance

Secondary study objectives

Relapse

Urine Drug Screens

Other study objectives

Compliance - Week 4

Compliance - Week 8

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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