Evaluating Adaptive Dispenser Initiation Protocols for MySafeRx During Post-detox Buprenorphine Treatment- a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Other: MySafeRx Inspire Plus; Other: MySafeRx Inspire Flex

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33610
      • ACTS Adult Addiction Receiving Facility (AARF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MySafeRx Group A-(coaching + medication dispenser); 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.	Other: MySafeRx Inspire Plus; 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.
Experimental: MySafeRx Group B-(coaching + dispenser based on clinical need); 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.	Other: MySafeRx Inspire Flex; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of days engaged in observed daily dosing of Buprenorphine during first 2 weeks.	To examine the difference in engagement defined as the proportion of participants assigned to Group A or Group B, who have an observed B/N dosing on at least 10 out of the first 14 days.	Between the day after detox discharge to two-week time point
COVID-19 Infections	To examine the differences of COVID-19 infection between MySafeRx Group A (coaching + medication dispenser) MySafeRx Group B in comparison with the local treatment sites overall program incidence rate during the time period. Measured with COVID-19 self-report survey.	24 weeks
Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)	To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on the number of self-reported, county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study.	24 weeks
Opioid-Related Death Rates	To examine the effect of RME + MySafeRx Group A (coaching + medication dispenser) + MySafeRx Group B (coaching + medication dispenser based on clinical need) on all opioid-related deaths (in which opioids were present at time of death), as collected through county coroner reports and community network reports, throughout the 24 weeks of the study.	24 weeks

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Cambridge Health Alliance

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): August 26, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: PRO00038163 - Pilot; R01CE003039 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After publication and within 12 months of completion of the analysis of study primary aims, anonymous and de-identified data will be made available at the Open Science Framework (http://osf.io/) and/or Harvard Dataverse (https://dataverse.harvard.edu/) so that other investigators can verify or follow-up on the reported analyses.
• IPD Sharing Access Criteria: Anonymous and de-identified data will be stored on the Open Science Framework website (http://osf.io/) and/or Harvard Dataverse to be made available to other researchers to verify the research results. Before publication, only USF and CHA investigators will have direct access to the data, and only the CHA HERLab investigators will have access to the analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No