MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE)
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedDecember 12, 2018
December 1, 2018
1.8 years
October 20, 2016
December 10, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Adherence
Feasibility will be measured by percentage of study days with confirmation of supervised self-administration of medication.
4 weeks
Usability
Level of patient usability as measured by system usability scale
2 weeks, 4 weeks
Acceptability
Level of patient acceptability of system
4 weeks
Study Arms (1)
MySafeRx Intervention
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants must:
- Be between the ages of 18 and 39 years old.
- Be able to provide informed consent.
- Be clinically diagnosed with opioid dependence (DSM-IV) or opioid use disorder (DSM-5).
- Be currently in Medication-Assisted Treatment (MAT) with buprenorphine.
- Test positive for illicit opioid use within the past week.
- Have an Android smartphone or tablet device with current access to the internet through secure WiFi and/or a mobile data plan.
- Be able to meet in a confidential place for scheduled videoconferencing call with Mobile Recovery Coach on a daily basis.
You may not qualify if:
- Participants must not:
- Be younger than 18 or older than 39 years of age.
- Be non-English speaking.
- Be otherwise unable to complete informed consent.
- Be in their third trimester of pregnancy.
- Have cognitive deficits that may limit their ability to complete study procedures.
- Receive a twice daily prescription of buprenorphine.
- 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.
- Exhibit signs of severe mental illness such as psychoses, present with active suicidal ideation, or otherwise be a risk to themselves or others.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cambridge Health Alliancelead
- MedicaSafe, Inc.collaborator
- MySafeRx, Inccollaborator
- Dartmouth Collegecollaborator
Study Sites (1)
Cambridge Health Alliance
Cambridge, Massachusetts, 02139, United States
Related Publications (2)
Schuman-Olivier Z, Weiss RD, Hoeppner BB, Borodovsky J, Albanese MJ. Emerging adult age status predicts poor buprenorphine treatment retention. J Subst Abuse Treat. 2014 Sep;47(3):202-12. doi: 10.1016/j.jsat.2014.04.006. Epub 2014 May 20.
PMID: 24953168BACKGROUNDSchuman-Olivier Z, Borodovsky JT, Steinkamp J, Munir Q, Butler K, Greene MA, Goldblatt J, Xie HY, Marsch LA. MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Addict Sci Clin Pract. 2018 Sep 24;13(1):21. doi: 10.1186/s13722-018-0122-4.
PMID: 30249279BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zev Schuman-Olivier
Cambridge Health Alliance; Harvard Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 24, 2016
Study Start
November 1, 2016
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
December 12, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share