Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement in B/N Treatment -RCT (MySafeRx)

Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement and Retention in B/N Treatment (MySafeRx) - RCT

Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving Buprenorphine/ Naloxone (B/N) 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 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• Status: Withdrawn
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Other: Standard Care; Other: MySafeRx™

Detailed Description

The objective of this study is to conduct a randomized controlled trial (RCT) 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 B/N treatment after detox in a county where access to outpatient, take-home B/N prescriptions are more limited compared to in-person daily B/N dosing and treatment. This study seeks to expand our understanding about what works to prevent opioid overdose by incorporating a RCT 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. This study will generate new knowledge about the most effective way to prevent overdose and engage patients in B/N treatment with observed daily dosing.

The primary aim of this study is:

Engagement: To examine the effect of Remote Motivational Enhancement (RME) sessions + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on early engagement in outpatient B/N treatment based on the number of daily doses of prescribed B/N during the first 5 weeks post-detox.

Hypothesis: Participants enrolled in RME + MySafeRx Inspire Flex arm will be engaged in outpatient B/N treatment with significantly higher number of daily doses of prescribed B/N during the first 5 weeks post-detox than the information alone arm.

Secondary Aims:

Early Engagement: To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment on early engagement in B/N treatment based on the proportion of participants a) who receive at least one outpatient B/N dose in first 7 days and b) who receive at least one outpatient B/N prescription at ACTS in the first 14 days post discharge from detox.

Opioid-Related Deaths: To examine the effects of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N on number of opioid-related deaths (as measured by county coroner report and clinic report) during the 6-months after discharge from inpatient detox.

Opioid Use (toxicology): To examine the differences in opioid use as measured by monthly urine toxicology for illicit opioids between MySafeRx Inspire Flex and information alone + ACTS Standard Care B/N treatment during a 24-week study period.

Other Pre-Specified Outcomes:

Overdoses: To examine the effect of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N treatment on the number of self-reported (with and without naloxone administered), county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study follow-up.

Opioid Use (self-report): To examine the differences in self-reported illicit opioid use between MySafeRx Inspire Flex information alone + ACTS Standard Care B/N treatment.

Treatment Retention: To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on retention in B/N treatment based on active B/N prescription at 12 and 24-week period.

Mental Health Symptoms: To examine the differences in mental health symptomatology using the BSI between MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment during the 24-week study period.

For the current proposal, the investigators plan to recruit up to 120 B/N eligible patients during the high-risk period of transition out of detox into outpatient B/N treatment in order to be able to randomize 104 participants. Study participants will be recruited from the outpatient detox program at ACTS in Tampa, Florida. The investigators aim to recruit 2 patients a week for the study and randomize, on average, one patient to the MySafeRx program each week. Study participants will participate in a baseline assessment and six follow-up assessments at week 4, week 8, week 12, week 16, week 20, and week 24. These assessments will be conducted by the project coordinator and will occur via phone or at the ACTS facility (baseline assessment will always occur at ACTS detox prior to discharge). To protect the privacy of this information, the assessments will be identified only by a code number linked to study participants with a key that is only accessible to the data analyst. Study assessments will take approximately one and a half hours to complete.

Once the participant has consented, completed the baseline assessment, and a PI or Co-I has approved them to participate, they will be randomized to either MySafeRx or Standard Care. Given the study population, the investigators assume there will be some loss of participants at follow-up. The investigators have planned for this in the assessment of appropriate sample size, as well as in the data analysis procedures.

• Study Type: Interventional
• 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) (Nasreddine,et al., 2005)
• homeless without any expressed interest in attaining housing after detox discharge
• 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 B/N
• 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
• is non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Care; Standard Care through detox-based opioid treatment with B/N and weekly urine toxicology screening	Other: Standard Care; Standard Care through office-based opioid treatment with B/N dosing, on-site counseling and regular urine toxicology screening
EXPERIMENTAL: MySafeRx™ Intervention; 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 medication storage device, and a standardized protocol for supervising self-administration of medication via videoconferencing.	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 B/N medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Remote Motivational Enhancement (RME) Sessions on Early Engagement in B/N Treatment	To examine the effect of Remote Motivational Enhancement (RME) sessions + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on early engagement in outpatient B/N treatment based on the number of daily doses of prescribed B/N during the first 5 weeks post-detox.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of days engaged in dosing of B/N during first 2 weeks.	To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment on early engagement in B/N treatment based on the proportion of participants a) who receive at least one outpatient B/N dose in first 7 days and b) who receive at least one outpatient B/N prescription at ACTS in the first 14 days post discharge from detox.	2 weeks post discharge
Opioid-Related Deaths	To examine the effects of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N on number of opioid-related deaths (as measured by county coroner report and clinic report) during the 6-months after discharge from inpatient detox.	24 weeks
Illicit Opioid Use Measured by Urine Toxicology Screening	To examine the differences in opioid use as measured by monthly urine toxicology for illicit opioids between MySafeRx Inspire Flex and information alone + ACTS Standard Care B/N treatment during a 24-week study period.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)	To examine the effect of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N treatment on the number of self-reported (with and without naloxone administered), county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study follow-up.	24 weeks
Self-Reported Opioid Use	To examine the differences in self-reported illicit opioid use between MySafeRx Inspire Flex information alone + ACTS Standard Care B/N treatment.	24 Weeks
Outpatient Buprenorphine Treatment Retention	To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on retention in B/N treatment based on active B/N prescription at 12 and 24-week period.	24 Weeks
Mental Health Symptomatology	To examine the differences in mental health symptomatology using the BSI between MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment during the 24-week study period.	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 (ANTICIPATED): December 31, 2021
• Primary Completion (ANTICIPATED): April 5, 2022
• Study Completion (ANTICIPATED): April 5, 2022

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: March 1, 2021

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 - RCT

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
• product manufactured in and exported from the U.S.: Yes