Trial Outcomes & Findings for Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study (NCT NCT04656899)
NCT ID: NCT04656899
Last Updated: 2023-03-14
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-03-14
Participant Flow
All participants were recruited from Buprenorphine and Buprenorphine/Naloxone clinics in the NW USA region
84 individuals were assessed for eligibility, of these 41 were randomized
Participant milestones
| Measure |
Pillsy Arm
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
|
Overall Study
COMPLETED
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study
Baseline characteristics by cohort
| Measure |
Pillsy Arm
n=19 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=22 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 11 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer not to say
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment
Unemployed
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Employment
Employed
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Marital Status
Single
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Marital Status
Married
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Last Buprenorphine Initiation
Not Eligible
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Last Buprenorphine Initiation
0 to 30 days ago
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Last Buprenorphine Initiation
31 to 60 days ago
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Last Buprenorphine Initiation
60 to 90 days ago
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Last Buprenorphine Initiation
91 to 120 days ago
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Last Buprenorphine Initiation
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline Opioid Use Disorder (OUD) Diagnostic and Statistical Manual (DSM) Diagnosis
Mild
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Baseline Opioid Use Disorder (OUD) Diagnostic and Statistical Manual (DSM) Diagnosis
Moderate
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline Opioid Use Disorder (OUD) Diagnostic and Statistical Manual (DSM) Diagnosis
Severe
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange 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).
Outcome measures
| Measure |
Pillsy Arm
n=19 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=22 Participants
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.
|
|---|---|---|
|
Mean Medication Possession Ratio
|
0.839 Medication supply / days in time period
Standard Deviation 0.652
|
0.752 Medication supply / days in time period
Standard Deviation 0.713
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Pillsy Arm
n=19 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=22 Participants
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.
|
|---|---|---|
|
Participant Engagement
|
71.3 Days
Standard Deviation 28.2
|
52.6 Days
Standard Deviation 38.8
|
SECONDARY outcome
Timeframe: Week 1Week 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.
Outcome measures
| Measure |
Pillsy Arm
n=18 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=20 Participants
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.
|
|---|---|---|
|
Week 1, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 weeksParticipant self-report of other substance use (alcohol, cigarettes, and illicit opioids) is assessed with Timeline Follow-back measure
Outcome measures
| Measure |
Pillsy Arm
n=19 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=22 Participants
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.
|
|---|---|---|
|
Number of Days Participant Self-reported Other Substance Use
Alcohol
|
0.82 Days of use
Standard Deviation 3.89
|
0.24 Days of use
Standard Deviation 0.83
|
|
Number of Days Participant Self-reported Other Substance Use
Cigarettes
|
7.83 Days of use
Standard Deviation 12.81
|
9.02 Days of use
Standard Deviation 13.06
|
|
Number of Days Participant Self-reported Other Substance Use
Illicit opioids
|
0.33 Days of use
Standard Deviation 2.04
|
0.45 Days of use
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants in both groups (Pillsy and SAU) were asked by their medical provider frequently to provide urine samples as part of their standard of care treatment. This was not on a set schedule. Results of all urinalyses were provided to the research team for analysis to evaluate change in use of non-prescribed opioids over the course of the study.
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.
Outcome measures
| Measure |
Pillsy Arm
n=71 Urinalysis
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=75 Urinalysis
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.
|
|---|---|---|
|
Change in Use of Non-prescribed Opioids
|
2.17 Urinanalysis
Standard Deviation 7.25
|
1.68 Urinanalysis
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Week 6Week 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.
Outcome measures
| Measure |
Pillsy Arm
n=16 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=14 Participants
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.
|
|---|---|---|
|
Week 6, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
|
14 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 12Week 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.
Outcome measures
| Measure |
Pillsy Arm
n=13 Participants
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.
Reminders messages to improve adherence.: 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.
|
Service as Usual Arm
n=12 Participants
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.
|
|---|---|---|
|
Week 12, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System
|
11 Participants
|
12 Participants
|
Adverse Events
Pillsy Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Service as Usual Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Crystal Smith (backup: Dr. Sterling M. McPherson)
Washington State University Elson S. Floyd College of Medicine, Analytics and PsychoPharmacology Laboratory (APPL)
Phone: (509) 368-6876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place