Opiate AddictionNCT02243670
Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
A study testing AiCure monitoring and intervention in people with Opiate Addiction and Medication Non-adherence, run by AiCure at 1 site in United States.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Addiction, Medication Non-adherence, Addiction
- What is being tested?
- AiCure monitoring and intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Validity of Using a Novel Artificial Intelligence Platform to Monitor and Optimize Medication Adherence in Patients Receiving Opioid Replacement Therapy
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.
Read the 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 recruited for the study. All participants will receive their doctor's treatment-as-usual. Patients not currently prescribed Zubsolv® will be switched to Zubsolv®.
Study visits include a screening visit, one baseline visit (which ideally will occur between 7 and 14 days after the screening visit), and bi-weekly visits for the 12 weeks (six visits) following the baseline visit. During the baseline visit, participants will be trained on how to use the AiCure app. Training consists of a number of interactive training steps to teach the participant how to use the app correctly. Participants will be provided with three placebo tablets for the training.
Study participants will be reimbursed to cover their time and transportation costs in accordance with Institutional Review Board (IRB) guidelines. Participants will receive contingency management (CM) to reinforce regular use of the app. Orexo AB will provide the study drug, Zubsolv®, to all participants throughout the 12-week treatment duration.
For the length of the study, participants will be requested to take each dose of their prescribed Zubsolv® regimen using the AiCure app. Each medication administration event will be saved onto the participant's smartphone and encrypted data (including de-identified video and time and date of administration) will be automatically transmitted to the centralized dashboard. Research staff will have access to the dashboard to view real-time and detailed dosing histories for each participant. Access to the dashboard is roles-based and password-protected. If a participant does not dose using the AiCure app (misses/skips a dose), self-reports on the device or over the phone, or is tagged for suspicious behavior, the participant will receive a combination of automated SMS text messages and tailored SMS text messages / phone calls from research staff based on the pre-defined escalation protocol.
- Being tested
- AiCure monitoring and intervention
- 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
- Medical subject headings
- Opioid-Related Disorders, Medication Adherence, Behavior, Addictive, Patient Compliance, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AiCure monitoring and interventionDevice
Also called Automated DOT
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.
| Study group | Role | What they receive |
|---|---|---|
| AiCure monitoring and intervention | Experimental | Participants will use the AiCure app to monitor ingestion of all prescribed doses of Zubsolv®. Receives: Device: AiCure monitoring and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
To evaluate the acceptability of using AiCure to optimize care pathways.
Optimization of care pathways will be measured by assessing the sustainability of AiCure use over 12 weeks (retention rates) and measuring the fraction of bi-weekly urines positive for illicit opioids (urine drug screens) compared to historical data.
Measured: 12 weeks
To measure the reliability and validity of AiCure in detecting interruptions in treatment.
Comparing the sensitivity of AiCure adherence data and pharmacokinetic data in detecting interruptions in treatment.
Measured: 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).
Measured: 12 weeks
The change in participant's psychosocial well being over time as measured by the seven subscales of the Addiction Severity Index (ASI).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiCure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orexo AB, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Alain Litwin, MD, Principal investigator, Montefiore Medical CenterAdam Hanina, MBA, MPhil, Study director, AiCure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243670
- Sponsor's protocol ID
- AIC-HHSN271201300036C-01
- Other IDs
- HHSN271201300036C
- Status last verified
- Sep 2017
- First submitted
- 16 Sep 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Validity of Using a Novel Artificial Intelligence Platform to Monitor and Optimize Medication Adherence in Patients Receiving Opioid Replacement Therapy
- ClinicalTrials.gov ID
- NCT02243670
- Acronym / sponsor ID
- AIC-HHSN271201300036C-01
- Keywords
- opioid addiction, opioid substitution therapy, addiction, buprenorphine maintenance treatment, opioid dependence, substitution treatment, noncompliance, opiate addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AiCureIndustry (pharma, biotech, devices)
- Collaborators
- Orexo AB, Montefiore Medical Center
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 recruited for the study. All participants will receive their doctor's treatment-as-usual. Patients not currently prescribed Zubsolv® will be switched to Zubsolv®.
Study visits include a screening visit, one baseline visit (which ideally will occur between 7 and 14 days after the screening visit), and bi-weekly visits for the 12 weeks (six visits) following the baseline visit. During the baseline visit, participants will be trained on how to use the AiCure app. Training consists of a number of interactive training steps to teach the participant how to use the app correctly. Participants will be provided with three placebo tablets for the training.
Study participants will be reimbursed to cover their time and transportation costs in accordance with Institutional Review Board (IRB) guidelines. Participants will receive contingency management (CM) to reinforce regular use of the app. Orexo AB will provide the study drug, Zubsolv®, to all participants throughout the 12-week treatment duration.
For the length of the study, participants will be requested to take each dose of their prescribed Zubsolv® regimen using the AiCure app. Each medication administration event will be saved onto the participant's smartphone and encrypted data (including de-identified video and time and date of administration) will be automatically transmitted to the centralized dashboard. Research staff will have access to the dashboard to view real-time and detailed dosing histories for each participant. Access to the dashboard is roles-based and password-protected. If a participant does not dose using the AiCure app (misses/skips a dose), self-reports on the device or over the phone, or is tagged for suspicious behavior, the participant will receive a combination of automated SMS text messages and tailored SMS text messages / phone calls from research staff based on the pre-defined escalation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AiCure monitoring and intervention | Experimental | Device: AiCure monitoring and interventionParticipants will use the AiCure app to monitor ingestion of all prescribed doses of Zubsolv®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AiCure monitoring and interventionAlso: Automated DOTParticipants 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. | Device | AiCure monitoring and intervention |
Primary outcome
To evaluate the feasibility and acceptability to participants and study staff in using AiCure to monitor medication adherence.
Time frame: 12 weeks
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.
4 secondary outcomes
To evaluate the acceptability of using AiCure to optimize care pathways.
Time frame: 12 weeks
To measure the reliability and validity of AiCure in detecting interruptions in treatment.
Time frame: 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).
Time frame: 12 weeks
The change in participant's psychosocial well being over time as measured by the seven subscales of the Addiction Severity Index (ASI).
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Litwin, MD principal investigator
Montefiore Medical Center
Adam Hanina, MBA, MPhil study director
AiCure
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AiCure monitoring and intervention in people with Opiate Addiction and Medication Non-adherence, run by AiCure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility and acceptability to participants and study staff in using AiCure to monitor medication adherence. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.