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

Completed · Not applicable

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID: NCT04656899
Run by: Washington State University
People needed: 41
Starts: 2020-12-06
Expected to finish: 2021-10-11
Last updated by the study team: 2023-03-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Washington State University — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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