NCT04822168

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 31, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
Last Updated

December 7, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

February 27, 2020

Last Update Submit

November 22, 2021

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Proportion of days engaged in dosing of B/N during first 2 weeks.

    2 weeks post discharge

  • Opioid-Related Deaths

    24 weeks

  • Illicit Opioid Use Measured by Urine Toxicology Screening

    24 weeks

Other Outcomes (4)

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

    24 weeks

  • Self-Reported Opioid Use

    24 Weeks

  • Outpatient Buprenorphine Treatment Retention

    24 Weeks

  • +1 more other outcomes

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard Care through detox-based opioid treatment with B/N and weekly urine toxicology screening

Other: 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 B/N medication within a secure medication storage device, and a standardized protocol for supervising self-administration of medication via videoconferencing.

Other: MySafeRx™

Interventions

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 B/N medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.

MySafeRx™ Intervention
Standard CareOTHER

Standard Care through office-based opioid treatment with B/N dosing, on-site counseling and regular urine toxicology screening

Standard Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 30249279BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kathleen Moore, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

  • Zev Schuman-Olivier, MD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR
0

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

February 27, 2020

First Posted

March 30, 2021

Study Start

December 31, 2021

Primary Completion

April 5, 2022

Study Completion

April 5, 2022

Last Updated

December 7, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

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.

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)