Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study (MAP4BUP)

Washington State University

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Behavioral: Reminders messages to improve adherence.

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04656899

IRB 17809

1R44DA049629-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Pillsy arm

Active Comparator group

Description:

Participants in the Pillsy arm will receive a prescription for buprenorphine-naloxone with an ''active'' Pillsy smart cap that will continuously collect data on pill bottle openings, missed doses, text messages sent, automated phone calls made. A participant who misses an entire day of buprenorphine-naloxone will automatically receive a survey about cravings and risk of relapse.

Treatment:

Behavioral: Reminders messages to improve adherence.

Service as usual arm

No Intervention group

Description:

Participants in the Service As Usual arm will receive a prescription for buprenorphine-naloxone with an ''inactive'' Pillsy smart cap that will track openings but will not provide reminders or any other messaging. They will receive a basic application that can deploy patient satisfaction surveys.