NCT04656899: MAP4BUP

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

Completed NA Results posted Last updated 14 March 2023

What this trial tests

NA trial testing Reminders messages to improve adherence. in Opioid-use Disorder in 41 participants. Completed in 11 October 2021.

Timeline

6 December 2020

Primary endpoint
11 October 2021

11 October 2021

Quick facts

Lead sponsor	Washington State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	41
Start date	6 December 2020
Primary completion	11 October 2021
Estimated completion	11 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Reminders messages to improve adherence.

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Washington State University

Who can join

Adults 18 to 60, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Medication Possession Ratio Primary · 12 weeks

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).

Group	Value	95% CI
Pillsy Arm	0.839	± 0.652
Service as Usual Arm	0.752	± 0.713

Participant Engagement Secondary · 12 weeks (Assessed at screening visit, week 1 visit, week 6 visit and week 12 visit)

Participant engagement quantified through days of retention in treatment.

Group	Value	95% CI
Pillsy Arm	71.3	± 28.2
Service as Usual Arm	52.6	± 38.8

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

Week 1 "Pillsy Satisfaction Survey". "Yes" vs "No" question: "Are you satisfied with the Pillsy system overall?". Outcome data measured is count of participants endorsing yes.

Group	Value	95% CI
Pillsy Arm	14
Service as Usual Arm	17

Number of Days Participant Self-reported Other Substance Use Secondary · 12 weeks

Participant self-report of other substance use (alcohol, cigarettes, and illicit opioids) is assessed with Timeline Follow-back measure

Alcohol

Group	Value	95% CI
Pillsy Arm	0.82	± 3.89
Service as Usual Arm	0.24	± 0.83

Cigarettes

Group	Value	95% CI
Pillsy Arm	7.83	± 12.81
Service as Usual Arm	9.02	± 13.06

Illicit opioids

Group	Value	95% CI
Pillsy Arm	0.33	± 2.04
Service as Usual Arm	0.45	± 2

Change in Use of Non-prescribed Opioids Secondary · 12 weeks

Use of non-prescribed opioids is assessed via urinalysis (UA) by the treatment team at Ideal Option, as a standard of care. Ideal Option will share this data with the study team (through signed data use agreement). Our study team will evaluate change in use of non-prescribed opioids over the course of the study, based on the data provided by the clinic. Below it is expressed as the mean number of illicit opioid positive UAs submitted out of the total number of UAs submitted for each arm.

Group	Value	95% CI
Pillsy Arm	2.17	± 7.25
Service as Usual Arm	1.68	± 4.39

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

Week 6 "Pillsy Satisfaction Survey". "Yes" vs "No" question: "Are you satisfied with the Pillsy system overall?" Outcome data measured is count of participants endorsing yes.

Group	Value	95% CI
Pillsy Arm	14
Service as Usual Arm	11

Week 12, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System Secondary · Week 12

Week 12 "Pillsy Satisfaction Survey". "Yes" vs "No" question: "Are you satisfied with the Pillsy system overall?" Outcome data measured is count of participants endorsing yes.

Group	Value	95% CI
Pillsy Arm	11
Service as Usual Arm	12

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability.
   Smith CL, Keever A, Bowden T, Olson K, et al · · 2023 · cited 3× · PMID 37074780 · DOI 10.2196/40437
2. Mobile Medication Adherence Platform for Buprenorphine (MAP4BUP): A Phase I feasibility, usability and efficacy pilot randomized clinical trial.
   McPherson SM, Smith CL, Hall L, Miguel AQ, et al · · 2024 · PMID 38306822 · DOI 10.1016/j.drugalcdep.2024.111099