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

NCT04822168 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-12-07

No results posted yet for this study

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.

Conditions

  • Opioid-use Disorder

Interventions

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.

OTHER

Standard Care

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

Sponsors & Collaborators

  • Cambridge Health Alliance

    collaborator OTHER

  • University of South Florida

    lead OTHER

Principal Investigators

  • Kathleen Moore, PhD · University of South Florida

  • Zev Schuman-Olivier, MD · Cambridge Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-04-05
Completion
2022-04-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822168 on ClinicalTrials.gov