N/A
Completed N=41
Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study
Source: ClinicalTrials.gov NCT04656899 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Mean Medication Possession Ratio — 0.839; 0.752 Medication supply / days in time period
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Medication Possession Ratio |
0.839; 0.752 | — |
| SECONDARY Participant Engagement |
71.3; 52.6 | — |
| SECONDARY Week 1, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System |
14; 17 | — |
| SECONDARY Number of Days Participant Self-reported Other Substance Use |
0.82; 0.24; 7.83; 9.02; 0.33; 0.45 | — |
| SECONDARY Change in Use of Non-prescribed Opioids |
2.17; 1.68 | — |
| SECONDARY Week 6, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System |
14; 11 | — |
| SECONDARY Week 12, Number of Participants Satisfied With Pillsy Usability and Reminder Feedback System |
11; 12 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04656899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.