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Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study

NCT04656899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-03-14

Study results available
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Summary

The investigators will conduct a phase I study involving 41 participants selected randomly among patients prescribed buprenorphine-naloxone for opioid misuse as a feasibility trial of the study of the Pillsy device. The study will track the effectiveness of the Pillsy technology and associated smartphone application by measuring adherence to buprenorphine-naloxone therapy and patient satisfaction with the application and the Pillsy device.

Conditions

  • Opioid-use Disorder

Interventions

BEHAVIORAL

Reminders messages to improve adherence.

If the participant does not take their medicine at the correct time, a light on the smart pill cap begins to flash. If the bottle is not opened within 20 minutes, the Pillsy application sends an SMS text reminder to the participant's phone. If the bottle is not opened within 60 minutes, the participant receives an automated phone call. The participant may also receive brief motivational phrases or craving surveys that can be tailored to participant needs and preferences. Also, based on pre-populated and adjustable craving and withdrawal levels, the participants' provider could be contacted automatically based on the thresholds being crossed. Pillsy also includes a "Pillsy Helpers" feature in which the patient can name friends and family members who will also receive a text message notification one hour after a missed dose.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Washington State University

    lead OTHER

Principal Investigators

  • Sterling McPherson, Ph.D. · Washington State University

  • Jeffrey LeBrun · Pillsy, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-06
Primary Completion
2021-10-11
Completion
2021-10-11

Countries

  • United States

Study Locations

More Related Trials

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 NCT04656899 on ClinicalTrials.gov