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

NCT04449744 | Completed DMC

• 2 other identifiers: PRO00038163 - PilotR01CE003039
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Biochemically-Confirmed Illicit Opioid Use

  24 weeks

• Outpatient Buprenorphine Medication Adherence

  12 weeks

• Outpatient Buprenorphine Treatment Engagement/ Retention

  24 weeks

Other Outcomes (4)

• Proportion of days engaged in observed daily dosing of Buprenorphine during first 2 weeks.

  Between the day after detox discharge to two-week time point

• COVID-19 Infections

  24 weeks

• Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)

  24 weeks

Study Arms (2)

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.

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.

Other: MySafeRx Inspire Flex

Interventions

MySafeRx Inspire Plus 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/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.

MySafeRx Group A-(coaching + medication dispenser)

MySafeRx Inspire Flex 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/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.

MySafeRx Group B-(coaching + dispenser based on clinical need)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• Cambridge Health Alliance: collaborator

Study Sites (1)

ACTS Adult Addiction Receiving Facility (AARF)

Tampa, Florida, 33610, United States

Location

Related Publications (1)

• 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.

  PMID: 30249279 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kathleen Moore, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Zev Schuman-Olivier, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 29, 2020
• Study Start: July 13, 2020
• Primary Completion: August 26, 2021
• Study Completion: September 30, 2021
• Last Updated: November 24, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)