Clinical trial NCT04656899: Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study
Official title: Connected Pharmacy Platform to Improve Adherence to Buprenorphine- Naloxone Prescription Treatment of Opioid Use Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-12-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subject can and has signed an Institutional Review Board (IRB) approved informed consent form (ICF).
* Age ≥18 and ≤60 years.
* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for Opioid use disorder (OUD).
* In the professional opinion of the prescribing provider, the patient requires buprenorphine-naloxone for Opioid use disorder.
* Owns a working smartphone.
* Agrees to abstain from opioids other than Opioid Agonist Therapy (OAT) during the study.
* Able to read and speak English.
* Can identify one study partner/caregiver who agrees to participate.

Exclusion Criteria:

* Have been prescribed chronic OAT treatment in the previous 12 months.
* Have known hypersensitivity to buprenorphine and/or naloxone.
* Are pregnant or lactating women or women of childbearing potential who are not using any form of birth control.
* Have a primary diagnosis of substance use disorder other than OUD or nicotine.
* Require opioids for the treatment of chronic pain.
* Have evidence of coagulopathy within 90 days prior to enrollment.
* Have clinically significant thrombocytopenia.
* Have screening serum aspartate (AST) and alanine aminotransferase (ALT) levels 3-fold higher than upper limits of normal.
* Have screening total bilirubin or creatinine levels 1.5-fold higher than the upper limits of normal.
* Use of other medications that are known to affect the outcome measures in this study including methadone.
* Are unable to provide voluntary informed consent.
* Have pending legal issues that could adversely affect the participant's freedom to participate.
* Cannot read or speak English.

Primary outcomes:
measure: Mean Medication Possession Ratio
timeFrame: 12 weeks
Secondary outcomes:
measure: Participant Engagement
timeFrame: 12 weeks (Assessed at screening visit, week 1 visit, week 6 visit and week 12 visit)
measure: Week 1, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
timeFrame: Week 1
measure: Number of Days Participant Self-reported Other Substance Use
timeFrame: 12 weeks
measure: Change in Use of Non-prescribed Opioids
timeFrame: 12 weeks
measure: Week 6, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
timeFrame: Week 6
measure: Week 12, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
timeFrame: Week 12
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Sterling McPherson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pillsy, Inc.
name: Jeffrey LeBrun
role: PRINCIPAL_INVESTIGATOR
References: