Status:
COMPLETED
Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
Lead Sponsor:
AiCure
Collaborating Sponsors:
Orexo AB
Montefiore Medical Center
Conditions:
Opiate Addiction
Medication Non-adherence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This study will employ a multi-site, single-arm design. A total of approximately 50-100 participants - patients stable for at least 2 weeks on their current opioid replacement medication - will be rec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02243670
Start Date
August 1 2016
End Date
March 1 2017
Last Update
September 12 2017
Active Locations (1)
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1
Montefiore Medical Center
New York, New York, United States, 10461