Opioid Use DisorderMySafeRxNCT02778282
MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence
A study testing MySafeRx™ in people with Opioid Use Disorder, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
Trial summary
The goal of the MySafeRx 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
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Mar 2017to 31 Aug 2021
- 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
- Women and men age 18-39, inclusive, who are competent, wish to participate and willing to provide informed consent.
- DSM-V diagnosis of opioid use disorder, moderate or severe
- Seeking to initiate buprenorphine treatment or currently receiving buprenorphine treatment but had recent positive illicit opioid urine toxicology or missed scheduled urine toxicology.
Who cannot join
- DSM-V diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, mental retardation, or autism.
- Substantial cognitive impairment (Montreal Cognitive Assessment < 25/30)
- Currently homeless
- Actively homicidal or suicidal with an imminent plan
- Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 3 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hawthorn Recovery Center
Bennington, Vermont, 05201
Mount Anthony Primary Care
Bennington, Vermont, 05201
Cambridge Health Alliance Outpatient Addiction Services
Somerville, Massachusetts, 02143
About this study
The goal of the MySafeRx 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, acceptability, and usability 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, we 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. Usability will be assessed with the validated system usability scale as a primary outcome. Feasibility, acceptability and initial efficacy based on opioid urine toxicology will all be assessed as secondary outcomes.
- 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.
MySafeRx™Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard Care through office-based opioid treatment with buprenorphine/naloxone and weekly urine toxicology screening |
| Standard Care + 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 Standard Care plus MySafeRx™. Receives: Other: MySafeRx™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects with adequate medication adherence
Feasibility will be demonstrated by MySafeRx achieving supervised self-administration of B/N on >= 30 out of the first 42 days (equivalent to an average of 5 out of 7 days) for at least 2/3 of subjects randomized to MySafeRx.
Measured: Day 42
Secondary outcomes (4)
Acceptability
Level of patient acceptability (mean score > 3 out of 5 on the 13-item satisfaction scale)
Measured: Day 42
Usability
Reported patient usability (mean score > 68 on the system usability scale)
Measured: 42 days
Initial Clinical Efficacy-Illicit opioid use
Percent negative weekly opioid urine toxicology
Measured: 6 weeks
Initial Clinical Efficacy-Medication adherence
Weekly self-reports of B/N adherence
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start24 Mar 2017
- Primary completion1 Nov 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zev Schuman-Olivier, Dartmouth-Hitchcock Medical Center
- Investigators
- Zev D Schuman-Olivier, MD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778282
- Sponsor's protocol ID
- 1R34DA040086 D14047
- Other IDs
- 1R34DA040086
- Acronym
- MySafeRx
- Status last verified
- Oct 2021
- First submitted
- 17 May 2016
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 24953168Aaron Bangor, Philip T. Kortum & James T. Miller (2008) An Empirical Evaluation of the System Usability Scale, International Journal of Human-Computer Interaction, 24:6, 574-594, DOI: 10.1080/10447310802205776
Schuman-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 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence
- ClinicalTrials.gov ID
- NCT02778282
- Acronym / sponsor ID
- MySafeRx / 1R34DA040086 D14047
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 May 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 MySafeRx 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, acceptability, and usability 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, we 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. Usability will be assessed with the validated system usability scale as a primary outcome. Feasibility, acceptability and initial efficacy based on opioid urine toxicology will all be assessed as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard Care through office-based opioid treatment with buprenorphine/naloxone and weekly urine toxicology screening |
| Standard Care + MySafeRx™ Intervention | Experimental | 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, and a standardized protocol for supervising self-administration of medication via videoconferencing. This arm represents Standard Care plus MySafeRx™. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women and men age 18-39, inclusive, who are competent, wish to participate and willing to provide informed consent.
- DSM-V diagnosis of opioid use disorder, moderate or severe
- Seeking to initiate buprenorphine treatment or currently receiving buprenorphine treatment but had recent positive illicit opioid urine toxicology or missed scheduled urine toxicology.
Key exclusion criteria (5 listed)
- DSM-V diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, mental retardation, or autism.
- Substantial cognitive impairment (Montreal Cognitive Assessment < 25/30)
- Currently homeless
- Actively homicidal or suicidal with an imminent plan
- Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 3 months.
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 |
|---|---|---|
| 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, and a standardized protocol for supervising self-administration of medication via videoconferencing. | Other | Standard Care + MySafeRx™ Intervention |
Primary outcome
Percent of subjects with adequate medication adherence
Time frame: Day 42
Feasibility will be demonstrated by MySafeRx achieving supervised self-administration of B/N on >= 30 out of the first 42 days (equivalent to an average of 5 out of 7 days) for at least 2/3 of subjects randomized to MySafeRx.
4 secondary outcomes
Acceptability
Time frame: Day 42
Usability
Time frame: 42 days
Initial Clinical Efficacy-Illicit opioid use
Time frame: 6 weeks
Initial Clinical Efficacy-Medication adherence
Time frame: 6 weeks
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 5 Oct 2021.
- 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.
- BackgroundAaron Bangor, Philip T. Kortum & James T. Miller (2008) An Empirical Evaluation of the System Usability Scale, International Journal of Human-Computer Interaction, 24:6, 574-594, DOI: 10.1080/10447310802205776
- 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 Center for Technology and Behavioral Health at DartmouthLink provided by the sponsor.
- Website for Vermont BlueprintLink 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 D Schuman-Olivier, MD principal investigator
Dartmouth College
3 sites 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 Dartmouth-Hitchcock Medical Center at 3 sites 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 3 inclusion and 5 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Percent of subjects with adequate medication adherence (time frame: Day 42). 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 NCT02778282, which also lists 3 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 5 Oct 2021.