Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy

NCT02243670 | Completed

• 2 other identifiers: AIC-HHSN271201300036C-01HHSN271201300036C
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Opiate Addiction; Medication Non-adherence; Addiction; Opioid Dependence

Keywords

opioid addiction; opioid substitution therapy; addiction; buprenorphine maintenance treatment; opioid dependence; substitution treatment; noncompliance; opiate addiction; Zubzolv® maintenance; adherence monitoring; directly observed therapy; medication adherence; adherence; mobile; electronic monitoring; wireless; mobile device; artificial intelligence; facial recognition; computer vision; visual confirmation; sublingual buprenorphine/naloxone; nonadherence

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility and acceptability to participants and study staff in using AiCure to monitor medication adherence.

  Participants and study staff using AiCure to monitor medication adherence will show high rates of physician satisfaction and user acceptance, based on a pre-post design using surveys and observations.

  12 weeks

Secondary Outcomes (4)

• To evaluate the acceptability of using AiCure to optimize care pathways.

  12 weeks

• To measure the reliability and validity of AiCure in detecting interruptions in treatment.

  12 weeks

• The degree of participant maximum craving (during the 24 hour period prior to the study visit) for opioids as measured by the Brief Substance Craving Scale (BSCS).

  12 weeks

• The change in participant's psychosocial well being over time as measured by the seven subscales of the Addiction Severity Index (ASI).

  12 weeks

Study Arms (1)

AiCure monitoring and intervention

EXPERIMENTAL

Participants will use the AiCure app to monitor ingestion of all prescribed doses of Zubsolv®.

Device: AiCure monitoring and intervention

Interventions

AiCure monitoring and intervention DEVICE

Participants will use the AiCure app to monitor ingestion of all prescribed doses of Zubsolv®. If a participant misses a dose, takes an incorrect dose, or their data are flagged for suspicious activity, they will be contacted by research staff or the AiCure study team through automated SMS text or by phone.

Also known as: Automated DOT

AiCure monitoring and intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• AiCure: lead
• Orexo AB: collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center

New York, New York, 10461, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Medication Adherence; Behavior, Addictive; Patient Compliance; Directly Observed Therapy

Interventions

Methods

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alain Litwin, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Adam Hanina, MBA, MPhil

  AiCure

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 18, 2014
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)