Opioid-use DisorderNCT04449744
Evaluating Adaptive Dispenser Initiation Protocols for MySafeRx During Post-detox Buprenorphine Treatment- a Pilot Study
A study testing MySafeRx Inspire Plus and MySafeRx Inspire Flex in people with Opioid-use Disorder, run by University of South Florida at 1 site in United States.
Trial summary
Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving buprenorphine treatment for opioid use disorder are a public health priority. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- MySafeRx Inspire Plus and MySafeRx Inspire Flex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 30 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 to 65 years
- opioid use disorder
- stepping down from inpatient detox services
- willing to engage in daily outpatient supervised dosing of B/N.
Who cannot join
- cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA < 25/30 relative exclusion requiring PI approval, absolute exclusion for MOCA<21/30)
- homeless
- reporting active homicidal or suicidal ideation with an imminent plan
- current mania or psychosis
- expected incarceration in next 3 months (those that are incarcerated during the study will be removed from the study)
- unable or unwilling to use a mobile device
Show all 12Show fewer
- medical contraindication to BUP
- unable to complete baseline assessments
- unstable medical illness who expect hospitalization in the next 3 months pregnant women (if a patient becomes pregnant while participating in this study, they will be withdrawn)
- prisoners
- court-ordered individuals
- unable to speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
ACTS Adult Addiction Receiving Facility (AARF)
Tampa, Florida, 33610
About this study
Official title: Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement and Retention in Buprenorphine Treatment (MySafeRx) - A Pilot Study
Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving buprenorphine treatment for opioid use disorder are a public health priority. This study will both investigate the effects of starting remote motivational enhancement during inpatient detoxification on rates of engagement in Buprenorphine/ Naloxone (B/N) treatment and evaluate the impact of MySafeRx, a mobile device application which integrates remote motivational coaching with daily observed dosing from secure electronic pill dispensers at home via videoconference, on treatment retention and overdose prevention. Broad dissemination of this new intervention could help communities across the nation expand and advance their capacity to increase B/N treatment engagement and retention, enhance medication adherence, and prevent overdose.
Read the detailed description
The objective of this study is to evaluate an innovative strategy among opioid use disorder patients being discharged from detox. This study will evaluate the extent to which remote motivational enhancement sessions via videoconference and the option for flexible daily dosing at home with MySafeRx can improve engagement and retention with Buprenorphine/Naloxone (B/N) treatment after detox in a county where access to B/N treatment has primarily been provided with in-person, onsite, daily dosing. This study seeks to expand the investigators understanding about what works to prevent opioid overdose by evaluating the effects of remote motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox facility and during early treatment in order to increase treatment engagement with daily outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to access the MySafeRx app and complete their daily motivational interview sessions. In addition, the study seeks to evaluate the effects of using a locked medication dispenser. The role of the dispenser has not been fully evaluated in the past, and evaluation is needed to determine if the dispenser is necessary at the start of a treatment program or only in response to those participants having issues with adherence or participants that are struggling. This pilot study will generate new knowledge about the most effective way to prevent overdose and engage patients in B/N treatment with observed daily dosing.
Hypothesis:
The investigators will examine whether acceptable levels of satisfaction with the MySafeRx platform, specifically the electronic pill dispenser, are achieved at the end of the pilot period.
Primary Aim:
Aim 1: To assess the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals).
Secondary Aims:
Aim 2: To examine the differences in positive urine toxicology screens between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need)
Aim 3: To examine medication adherence to B/N by assessing the differences between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) in the total number of observed B/N doses taken in the first 28 days, between weeks 3-6.
Aim 4: To examine the differential impact of two tele-health interventions of MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing through 24 weeks.
Exploratory COVID-19 Objectives:
Aim 5: To examine the differences of COVID-19 infection between MySafeRx Group A and MySafeRx Group B and compare with ACTS overall program incidence rate during the time period.
- Conditions
- Opioid-use Disorder
- Being tested
- MySafeRx Inspire Plus, MySafeRx Inspire Flex
- 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 Inspire PlusOther
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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
MySafeRx Inspire FlexOther
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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study by their clinical team.
| Study group | Role | What they receive |
|---|---|---|
| MySafeRx Group A-(coaching + medication dispenser) | Active comparator | 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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Receives: Other: MySafeRx Inspire Plus |
| MySafeRx Group B-(coaching + dispenser based on clinical need) | 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/naloxone medication within a manual lockbox, and a standardized protocol for supervising self-administration of medication via videoconferencing. Participants will be assessed bi-weekly by their clinical team for substance abuse, coaching and medication adherence, compliance with urine drug screen policies, safety/ risk or mental health concerns, and diversion. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study. Receives: Other: MySafeRx Inspire Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Medication Dispenser
To examine the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing. MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals). MySafeRx Participant Satisfaction Survey to assess for acceptability of electronic dispenser.
Measured: 12 weeks
Secondary outcomes (3)
Biochemically-Confirmed Illicit Opioid Use
To examine the differences in illicit opioid use throughout the 24 weeks of the study as measured by urine toxicology testing every 4 weeks between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need). Positive results for fentanyl, opiates, methadone and oxycodone will be measured at 6 time points every 4 weeks.
Measured: 24 weeks
Outpatient Buprenorphine Medication Adherence
To examine medication adherence to Buprenorphine (B/N) by assessing the differences between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) in the total number of observed B/N doses taken in the first 12 weeks. To be measured by examining adherence data from the study site EHR system and MySafeRx application.
Measured: 12 weeks
Outpatient Buprenorphine Treatment Engagement/ Retention
To examine the differential impact of two tele-health interventions of MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing through 24 weeks.To be measured by examining adherence data from the study site EHR system.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start13 Jul 2020
- Primary completion26 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Health Alliance
- Responsible party
- Sponsor
- Investigators
- Kathleen Moore, PhD, Principal investigator, University of South FloridaZev Schuman-Olivier, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449744
- Sponsor's protocol ID
- PRO00038163 - Pilot
- Other IDs
- R01CE003039
- Status last verified
- May 2020
- First submitted
- 11 Jun 2020
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.
Publications
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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement and Retention in Buprenorphine Treatment (MySafeRx) - A Pilot Study
- ClinicalTrials.gov ID
- NCT04449744
- Acronym / sponsor ID
- PRO00038163 - Pilot
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Cambridge Health Alliance
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Jun 2020 (actual)
- 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.
Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving buprenorphine treatment for opioid use disorder are a public health priority. This study will both investigate the effects of starting remote motivational enhancement during inpatient detoxification on rates of engagement in Buprenorphine/ Naloxone (B/N) treatment and evaluate the impact of MySafeRx, a mobile device application which integrates remote motivational coaching with daily observed dosing from secure electronic pill dispensers at home via videoconference, on treatment retention and overdose prevention. Broad dissemination of this new intervention could help communities across the nation expand and advance their capacity to increase B/N treatment engagement and retention, enhance medication adherence, and prevent overdose.
Detailed description
The objective of this study is to evaluate an innovative strategy among opioid use disorder patients being discharged from detox. This study will evaluate the extent to which remote motivational enhancement sessions via videoconference and the option for flexible daily dosing at home with MySafeRx can improve engagement and retention with Buprenorphine/Naloxone (B/N) treatment after detox in a county where access to B/N treatment has primarily been provided with in-person, onsite, daily dosing. This study seeks to expand the investigators understanding about what works to prevent opioid overdose by evaluating the effects of remote motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox facility and during early treatment in order to increase treatment engagement with daily outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to access the MySafeRx app and complete their daily motivational interview sessions. In addition, the study seeks to evaluate the effects of using a locked medication dispenser. The role of the dispenser has not been fully evaluated in the past, and evaluation is needed to determine if the dispenser is necessary at the start of a treatment program or only in response to those participants having issues with adherence or participants that are struggling. This pilot study will generate new knowledge about the most effective way to prevent overdose and engage patients in B/N treatment with observed daily dosing.
Hypothesis:
The investigators will examine whether acceptable levels of satisfaction with the MySafeRx platform, specifically the electronic pill dispenser, are achieved at the end of the pilot period.
Primary Aim:
Aim 1: To assess the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals).
Secondary Aims:
Aim 2: To examine the differences in positive urine toxicology screens between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need)
Aim 3: To examine medication adherence to B/N by assessing the differences between MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) in the total number of observed B/N doses taken in the first 28 days, between weeks 3-6.
Aim 4: To examine the differential impact of two tele-health interventions of MySafeRx Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing through 24 weeks.
Exploratory COVID-19 Objectives:
Aim 5: To examine the differences of COVID-19 infection between MySafeRx Group A and MySafeRx Group B and compare with ACTS overall program incidence rate during the time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MySafeRx Group A-(coaching + medication dispenser) | Active comparator | Other: MySafeRx Inspire PlusThe 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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. |
| MySafeRx Group B-(coaching + dispenser based on clinical need) | Experimental | Other: MySafeRx Inspire FlexThe 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/naloxone medication within a manual lockbox, and a standardized protocol for supervising self-administration of medication via videoconferencing. Participants will be assessed bi-weekly by their clinical team for substance abuse, coaching and medication adherence, compliance with urine drug screen policies, safety/ risk or mental health concerns, and diversion. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 to 65 years
- opioid use disorder
- stepping down from inpatient detox services
- willing to engage in daily outpatient supervised dosing of B/N.
Key exclusion criteria (12 listed)
- cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA < 25/30 relative exclusion requiring PI approval, absolute exclusion for MOCA<21/30)
- homeless
- reporting active homicidal or suicidal ideation with an imminent plan
- current mania or psychosis
- expected incarceration in next 3 months (those that are incarcerated during the study will be removed from the study)
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 Inspire PlusThe 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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. | Other | MySafeRx Group A-(coaching + medication dispenser) |
| MySafeRx Inspire FlexThe 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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study by their clinical team. | Other | MySafeRx Group B-(coaching + dispenser based on clinical need) |
Primary outcome
Acceptability of Medication Dispenser
Time frame: 12 weeks
To examine the acceptability of the electronic medication dispenser and evaluate the impact of using an alternative adaptive assessment-based procedure, by comparing. MySafeRx Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and MySafeRx Group B (participants only receive the electronic medication dispensers based on clinical evaluation and need after assessment at regular time intervals). MySafeRx Participant Satisfaction Survey to assess for acceptability of electronic dispenser.
3 secondary outcomes
Biochemically-Confirmed Illicit Opioid Use
Time frame: 24 weeks
Outpatient Buprenorphine Medication Adherence
Time frame: 12 weeks
Outpatient Buprenorphine Treatment Engagement/ Retention
Time frame: 24 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 24 Nov 2021.
- 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.
- Individual participant dataSharing planned: Yes. De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.
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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.
Kathleen Moore, PhD principal investigator
University of South Florida
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
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 Inspire Plus and MySafeRx Inspire Flex in people with Opioid-use Disorder, run by University of South Florida 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 4 inclusion and 12 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 24 Nov 2021. 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?
Acceptability of Medication Dispenser (time frame: 12 weeks). 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 NCT04449744, which also lists 1 linked publication.
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 24 Nov 2021.