NCT04656899

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

Connected Pharmacy Platform to Improve Adherence to Buprenorphine- Naloxone Prescription Treatment of Opioid Use Disorder.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Washington State University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this randomized, controlled trial in Phase I is to determine whether the Pillsy intervention can improve adherence to buprenorphine-naloxone compared to Service As Usual. This will be a collaborative study between WSU, Pillsy, Inc, and the clinical site Ideal Options (opioid use and other substance use disorders treatment center). The overarching goal is to evaluate if the use of the Pillsy system will improve treatment adherence. The study coordinator will work closely with the clinical site, conducting a scripted screening, by phone or in person, documenting substance use, addiction treatment history, medical and psychiatric history, medication, addiction treatment goals, and availability of social support. The Pillsy device is a smart cap that tracks pill bottle openings and uses lighted reminders to prompt patients when to take their medication. The Pillsy Helper feature is a smartphone application that sends text and phone reminders as well as links to the participant named family and friend support networks. The Pillsy Helpers feature allows participants to name friends and family members who will also receive a text message notification 1 hour after a missed dose to reach out to offer support. In addition, the prescriber will be contacted when the patient has missed a dose, giving the prescriber the opportunity to intervene. Study participants will be randomized to one of two groups. The control group will receive the Pillsy cap alone. The active group will receive the Pillsy cap and smartphone application with associated benefits. To measure adherence, all participants will provide a urine sample at each study visit and complete a questionnaire (ex: AUDIT, Fagerstrom, Addiction Severity Index, Timeline Follow-Back) and survey that assesses their satisfaction with treatment.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-06
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2020-12-07
• Last updated: 2023-03-14
• Results posted: 2023-02-10

Locations

1 site across 1 country: United States