MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE)

December 10, 2018 updated by: Cambridge Health Alliance
The goal of the MyMOBILE study is to evaluate the feasibility, acceptability, and usability of a novel platform that integrates text messaging reminders, secure electronic pill organizers, and daily remote brief motivational recovery support visits with a standardized protocol for supervised self-administration of buprenorphine via videoconferencing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Opioid use disorder is a serious public health issue. Buprenorphine/ Naloxone (B/N) is a partial opioid mu-receptor agonist dosed daily that prevents opioid withdrawal, blocks opioid euphoria and can prevent opioid overdose. Extended treatment with B/N increases rates of abstinence and outpatient treatment retention and decreases Hepatitis C (HCV) transmission. B/N treatment dropout is associated with relapse and overdose death.

B/N adherence may be a critical factor influencing retention and reducing overall healthcare costs. Also, B/N diversion is associated with poor adherence and has become increasingly common and worrisome. While many patients achieve stability after starting B/N treatment, more than 80% of 18-25 year olds leave treatment within a year with relapse as the most common reason. Ongoing illicit opioid use during treatment increases odds of relapse and dropout. The MySafeRx platform helps prescribers offer a higher level of support for vulnerable patients with opioid use disorder during periods of clinical instability. The MySafeRx platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of B/N medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. By offering this recovery support and medication adherence monitoring program during periods of instability, this system could improve treatment outcomes by ensuring increased adherence, while also preventing B/N diversion.

This study primarily seeks to demonstrate the feasibility of the MySafeRx platform among young adults (18-39 years, inclusive) with opioid use disorders. While each key component may have an individual therapeutic effect, the investigators hypothesize that an integrated process involving all key components may be necessary to unlock the full therapeutic potential of a mobile platform for daily remote supervised self-administration and diversion prevention among this group. Providing targeted motivational interviewing and recovery support at this context-specific moment of daily medication-taking when people are very receptive to treatment may offer a new opportunity for expanding how recovery support can be delivered.

This study will enroll patients (18-39 years old) in office-based opioid treatment currently prescribed buprenorphine by a CHA prescriber who had illicit-opioid positive urine screens in the past week or who have just received buprenorphine induction. We will start participants with MySafeRx using the MedicaSafe 3000 dispenser and will assess for feasibility, acceptability, and usability during a 30 day period. Assessments will be conducted at baseline, two and four weeks.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Cambridge Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants must:

  1. Be between the ages of 18 and 39 years old.
  2. Be able to provide informed consent.
  3. Be clinically diagnosed with opioid dependence (DSM-IV) or opioid use disorder (DSM-5).
  4. Be currently in Medication-Assisted Treatment (MAT) with buprenorphine.
  5. Test positive for illicit opioid use within the past week.
  6. Have an Android smartphone or tablet device with current access to the internet through secure WiFi and/or a mobile data plan.
  7. Be able to meet in a confidential place for scheduled videoconferencing call with Mobile Recovery Coach on a daily basis.

Exclusion Criteria:

Participants must not:

  1. Be younger than 18 or older than 39 years of age.
  2. Be non-English speaking.
  3. Be otherwise unable to complete informed consent.
  4. Be in their third trimester of pregnancy.
  5. Have cognitive deficits that may limit their ability to complete study procedures.
  6. Receive a twice daily prescription of buprenorphine.
  7. Exhibit use of an illicit substance or prescribed medication considered by the PI to be unsafe for use with the MySafeRx device or study procedures.
  8. Exhibit signs of severe mental illness such as psychoses, present with active suicidal ideation, or otherwise be a risk to themselves or others.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MySafeRx Intervention
The MySafeRx platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. This arm represents MySafeRx using the MedicaSafe 3000 electronic pill dispenser.
Other: MySafeRx
The MySafeRx platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine medication within a secure electronic pill dispenser (i.e., MedicaSafe 3000), and a standardized protocol for supervising self-administration of medication via videoconferencing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 4 weeks
Feasibility will be measured by percentage of study days with confirmation of supervised self-administration of medication.
4 weeks
Usability
Time Frame: 2 weeks, 4 weeks
Level of patient usability as measured by system usability scale
2 weeks, 4 weeks
Acceptability
Time Frame: 4 weeks
Level of patient acceptability of system
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge Health Alliance

Collaborators

Dartmouth College
MedicaSafe, Inc.
MySafeRx, Inc

Investigators

  • Principal Investigator: Zev Schuman-Olivier, Cambridge Health Alliance; Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimate)

October 24, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHA-IRB-1029/03/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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