Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy

Completed · Not applicable

Conditions studied: Opiate Addiction, Medication Non-adherence, Addiction, Opioid Dependence

In brief

This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any smartphone to automate directly observed therapy (Automated DOT®). Real-time patient adherence data are encrypted and automatically sent to a centralized web-based dashboard for use by healthcare professionals or research staff. Unlike Facetime® or Skype®, the system relies on computer vision algorithms to confirm the process of medication administration; no human review is necessary. The purpose of this study is to evaluate the feasibility and acceptability, and measure the accuracy, of the AiCure platform ("platform") in patients being treated for opioid dependence with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1) to assess the feasibility and acceptability to both participants and study staff in using AiCure to monitor medication adherence; 2) to evaluate the acceptability of using AiCure to optimize care pathways; and 3) to measure the reliability and validity of AiCure in detecting interruptions in treatment. To assess feasibility and acceptability of the platform, we will measure rates of physician satisfaction and user acceptance. Optimization of care pathways will be measured by assessing the sustainability of AiCure use over 12 weeks (retention rates) and measuring illicit opioid use (urine drug screens) compared to historical data. Reliability and validity of AiCure will be measured by comparing AiCure adherence against pharmacokinetic data. All participants will be requested to take each of their prescribed doses using the app. Participants will be able to download the app onto their own smartphone or will be provisioned a device at the start of the study. The data captured during the medication ingestion process will be automatically encrypted and stored on the participant smartphone and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be sent to study staff via email or SMS to prompt immediate intervention. In addition, all participants will receive treatment as usual.

Key facts

Study ID

NCT02243670

Run by

AiCure

People needed

9

Starts

2016-08-01

Expected to finish

2017-03-01

Last updated by the study team

2017-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is a male or female at least 18 years of age.
• Has been on a stable dose of buprenorphine/naloxone for at least 2 weeks.
• Is willing to sign a consent form to allow research staff to receive information from their healthcare provider that will verify above inclusion criteria (length of time on stable dose), to administer blood draws, and to perform diagnostic assessments as described in this protocol.
• Is willing to sign an agreement to return the AiCure provisioned device if not able to download AiCure app onto personal smartphone.
• Is willing to use the AiCure app properly each time they ingest their daily dose of buprenorphine/naloxone.
• Is willing to allow research staff (and good clinical practice-trained AiCure personnel) to contact them via the app or other specified means regarding issues related to medication non-adherence.
• Speaks and understands English well enough to participate in the informed consent process and the study assessments and procedures.
• Agrees to come for a research visit monthly for 12 weeks (three visits) after being accepted into the study and two times during screening/baseline.

You may not qualify if…

• Is unlikely to remain under the care of their healthcare provider for the duration of the study.
• Appears to be incapable of learning the AiCure system.
• In the opinion of the investigator, is someone who should not be part of the study due to behavioral, mental, physical, or other issues.
• Is under court mandate to obtain treatment.
• Has a known allergy to any of the substances comprising the study medication.
• Is planning to be detoxified from Zubzolv during the course of the study.

Where it is running

• Montefiore Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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