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

NCT04656899 | Completed Results DMC

• 2 other identifiers: IRB 178091R44DA049629-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Mean Medication Possession Ratio

  Change in adherence to buprenorphine-naloxone treatment assessed by medication possession ratio (MPR). This was calculated as mean over the course of the trial. MPR is the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period (time period varies based on length of prescription given by provider). MPR is typically expressed as a percentage, however below we express it as the result of the fraction. This measurement was based on pharmacy fills (days supply).

  12 weeks

Secondary Outcomes (6)

• Participant Engagement

  12 weeks (Assessed at screening visit, week 1 visit, week 6 visit and week 12 visit)

• Week 1, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System

  Week 1

• Number of Days Participant Self-reported Other Substance Use

  12 weeks

• Change in Use of Non-prescribed Opioids

  12 weeks

• Week 6, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System

  Week 6

Study Arms (2)

Pillsy arm

ACTIVE COMPARATOR

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.

Behavioral: Reminders messages to improve adherence.

Service as usual arm

NO INTERVENTION

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.

Interventions

Reminders messages to improve adherence. BEHAVIORAL

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.

Also known as: Flashing cap, Automated phone call.

Pillsy arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This was a Phase I study with the primary intention of establishing feasibility and acceptability. To determine whether or not the Pillsy intervention is effective, it is important to have a larger sample size in a Phase II trial.

Results Point of Contact

• Title: Dr. Crystal Smith (backup: Dr. Sterling M. McPherson)
• Organization: Washington State University Elson S. Floyd College of Medicine, Analytics and PsychoPharmacology Laboratory (APPL)

crystal.lederhos@wsu.edu

(509) 368-6876

Study Officials

• Sterling McPherson, Ph.D.

  Washington State University

  PRINCIPAL INVESTIGATOR

• Jeffrey LeBrun

  Pillsy, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: December 7, 2020
• Study Start: December 6, 2020
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: March 14, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)