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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44DA049629-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Engagement | Participant engagement quantified through days of retention in treatment. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sterling McPherson, Ph.D. | Washington State University | Principal Investigator |
| Jeffrey LeBrun | Pillsy, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State University | Spokane | Washington | 99202 | United States |
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84 individuals were assessed for eligibility, of these 41 were randomized
All participants were recruited from Buprenorphine and Buprenorphine/Naloxone clinics in the NW USA region
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Medication supply / days in time period | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Crystal Smith (backup: Dr. Sterling M. McPherson) | Washington State University Elson S. Floyd College of Medicine, Analytics and PsychoPharmacology Laboratory (APPL) | (509) 368-6876 | crystal.lederhos@wsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2021 | Oct 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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. |
| 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 | 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. | 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. | 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. | Week 12 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Last Buprenorphine Initiation | Count of Participants | Participants |
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| Baseline Opioid Use Disorder (OUD) Diagnostic and Statistical Manual (DSM) Diagnosis | Count of Participants | Participants |
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| OG001 | 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. |
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| Secondary | Participant Engagement | Participant engagement quantified through days of retention in treatment. | Posted | Mean | Standard Deviation | Days | 12 weeks (Assessed at screening visit, week 1 visit, week 6 visit and week 12 visit) |
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| Secondary | 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. | Posted | Count of Participants | Participants | Week 1 |
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| Secondary | 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 | Posted | Mean | Standard Deviation | Days of use | 12 weeks |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Urinanalysis | 12 weeks | Urinalysis | Urinalysis |
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| Secondary | 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. | Posted | Count of Participants | Participants | Week 6 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Week 12 |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
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| Illicit opioids |
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