Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy

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.

Inclusion criteria

• 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 criteria

• 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.