Opioid Use DisorderNCT02942199
MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE)
A study testing MySafeRx in people with Opioid Use Disorder, run by Cambridge Health Alliance at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- MySafeRx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- MySafeRx
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySafeRxOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MySafeRx Intervention | Experimental | 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. Receives: Other: MySafeRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Feasibility will be measured by percentage of study days with confirmation of supervised self-administration of medication.
Measured: 4 weeks
Usability
Level of patient usability as measured by system usability scale
Measured: 2 weeks, 4 weeks
Acceptability
Level of patient acceptability of system
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- MedicaSafe, Inc., MySafeRx, Inc, Dartmouth College
- Responsible party
- Sponsor
- Investigators
- Zev Schuman-Olivier, Principal investigator, Cambridge Health Alliance; Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942199
- Sponsor's protocol ID
- CHA-IRB-1029/03/16
- Status last verified
- Dec 2018
- First submitted
- 20 Oct 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24953168Schuman-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.
PubMed 30249279
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MySafeRx & MedicaSafe Open-Label Buprenorphine Induction and Lapse Evaluation (MyMOBILE)
- ClinicalTrials.gov ID
- NCT02942199
- Acronym / sponsor ID
- CHA-IRB-1029/03/16
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- MedicaSafe, Inc., MySafeRx, Inc, Dartmouth College
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MySafeRx Intervention | Experimental | Other: MySafeRxThe 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MySafeRxThe 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. | Other | MySafeRx Intervention |
Primary outcome
Adherence
Time frame: 4 weeks
Feasibility will be measured by percentage of study days with confirmation of supervised self-administration of medication.
Usability
Time frame: 2 weeks, 4 weeks
Level of patient usability as measured by system usability scale
Acceptability
Time frame: 4 weeks
Level of patient acceptability of system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Background: PubMed 24953168Schuman-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.
- Background: PubMed 30249279Schuman-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.
- Website for MySafeRx non-profitLink provided by the sponsor.
- Website for Cambridge Health Alliance Institutional Review BoardLink provided by the sponsor.
- Website for Cambridge Health Alliance Outpatient Addictions ServiceLink provided by the sponsor.
- Website for MedicaSafe 3000Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev Schuman-Olivier principal investigator
Cambridge Health Alliance; Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MySafeRx in people with Opioid Use Disorder, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942199, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.