Opioid-use DisorderMAP4BUPNCT04656899

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

A study testing Reminders messages to improve adherence. in people with Opioid-use Disorder, run by Washington State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Opioid-use Disorder
What is being tested?: Reminders messages to improve adherence.
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 6 Dec 2020to 11 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

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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 locations and contacts

1 site in 1 country.

United States1 site

Washington State University
Spokane, Washington, 99202

Other trials in United States

About this study

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

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.

Read the 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
Being tested: Reminders messages to improve adherence.
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reminders messages to improve adherence.Behavioural
Also called Flashing cap, Automated phone call.
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.

Study groups in NCT04656899
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 weeks

Secondary outcomes (6)

Participant Engagement
Participant engagement quantified through days of retention in treatment.
Measured: 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 "Pillsy Satisfaction Survey". "Yes" vs "No" question: "Are you satisfied with the Pillsy system overall?". Outcome data measured is count of participants endorsing yes.
Measured: Week 1
Number of Days Participant Self-reported Other Substance Use
Participant self-report of other substance use (alcohol, cigarettes, and illicit opioids) is assessed with Timeline Follow-back measure
Measured: 12 weeks
Change in Use of Non-prescribed Opioids
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.
Measured: 12 weeks
Week 6, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
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.
Measured: Week 6
Week 12, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
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.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 202011 Oct 2021

First posted7 Dec 2020
Study start6 Dec 2020
Primary completion11 Oct 2021
Study completion11 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04656899
Sponsor's protocol ID: IRB 17809
Other IDs: 1R44DA049629-01
Acronym: MAP4BUP
Status last verified: Feb 2023
First submitted: 15 Sep 2020
Last updated: 14 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Connected Pharmacy Platform to Improve Adherence to Buprenorphine- Naloxone Prescription Treatment of Opioid Use Disorder.
ClinicalTrials.gov ID: NCT04656899
Acronym / sponsor ID: MAP4BUP / IRB 17809
Conditions: Opioid-use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Washington State UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 6 Dec 2020 (actual)
Primary completion: 11 Oct 2021 (actual)
Study completion: 11 Oct 2021 (actual)
First posted: 7 Dec 2020 (actual)
Results: Posted 10 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pillsy arm	Active comparator	Behavioral: Reminders messages to improve adherence.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.
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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reminders messages to improve adherence.Also: Flashing cap, Automated phone call.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.	Behavioural	Pillsy arm

Primary outcome

Mean Medication Possession Ratio
Time frame: 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).

6 secondary outcomes

Participant Engagement
Time frame: 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
Time frame: Week 1
Number of Days Participant Self-reported Other Substance Use
Time frame: 12 weeks
Change in Use of Non-prescribed Opioids
Time frame: 12 weeks
Week 6, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
Time frame: Week 6
Week 12, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
Time frame: Week 12

Results and safety

Results posted to the registry on 10 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pillsy Arm	19	16
Service as Usual Arm	22	13

Primary outcome: Mean Medication Possession Ratio

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Medication supply / days in time period

Measure	Pillsy Arm n = 19	Service as Usual Arm n = 22
Value	0.839 (0.652)	0.752 (0.713)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pillsy Arm	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Service as Usual Arm	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sterling McPherson, Ph.D. principal investigator

Washington State University

Jeffrey LeBrun principal investigator

Pillsy, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reminders messages to improve adherence. in people with Opioid-use Disorder, run by Washington State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Medication Possession Ratio (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04656899.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.