Meta description: A wrist worn Strength Band Platform is studied to detect acute opioid dosing events and measure withdrawal using time stamped biometric data.
The study trains and evaluates an algorithm to identify dosing events from biometric data collected by wrist worn devices. Sponsors are OpiAID and the National Institute on Drug Abuse. The effort is currently recruiting participants as part of a regulated assessment for use in opioid use disorder treatment. For official details see the ClinicalTrials.gov record NCT07405398 at the following link: ClinicalTrials.gov NCT07405398.
What is the scope of the study and device under evaluation?
The intervention centers on a device named Strength Band Platform that collects time stamped biometric signals from wrist worn devices to identify acute opioid dosing events and quantify withdrawal in opioid dependent individuals. The sponsor seeks to train and evaluate the accuracy and reliability of this platform as part of a regulated assessment for use in opioid use disorder treatment. The description aligns with a regulatory minded approach to define intended use and performance under controlled conditions.
How will the evaluation be conducted and what data will be used?
The study relies on time stamped biometric data obtained from wrist worn devices to detect acute opioid dosing events. The Strength Band Platform is used as the intervention to train and assess an algorithm that identifies dosing events and captures withdrawal related signals in opioid dependent participants. Investigators aim to demonstrate accuracy and reliability through a structured evaluation plan under oversight consistent with medical device expectations.
In addition to the primary outcome, safety monitoring and data handling practices are emphasized. The public record on ClinicalTrials.gov provides the official study description and status to support regulatory transparency.
What regulatory considerations accompany this evaluation?
The activity mirrors a regulatory mindset that seeks to define intended use, performance boundaries and safety for a device used in the treatment of opioid use disorder. The sponsor identifies the Strength Band Platform as a device to be trained and evaluated for detection of acute dosing events and withdrawal signals using wrist based biometric data. The plan is to demonstrate performance and safety through formal evaluation and documentation in line with medical device expectations and MDR style guidance.
Who is involved and what is the recruitment status?
Sponsors are OpiAID and the National Institute on Drug Abuse. The project is listed as recruiting, indicating that enrollment is ongoing or planned. Official recruitment updates and site information are accessible through the public trial record for regulatory tracking and oversight.
What happens next and what should stakeholders monitor?
After completing the training and evaluation, investigators will compile performance results and safety observations to inform future labeling and regulatory discussions. Device developers, clinicians and regulators should monitor the public record for updates and for any changes to indications, risk disclosures or data handling practices.
- 1. What is being evaluated
A wrist worn Strength Band Platform is being evaluated to identify acute opioid dosing events from biometric data collected by wrist devices. - 2. Who sponsors the study
OpiAID and the National Institute on Drug Abuse sponsor the work. - 3. Where are official trial details
The ClinicalTrials.gov record NCT07405398 contains the official study description and status.
In summary the evaluation aims to establish device performance in detecting dosing events and assessing withdrawal indicators in opioid dependent individuals. The regulatory path will depend on results and on safety and data handling. Regulators and stakeholders should review the official trial record for updates on status and disclosures.
Disclaimer: This information is for professionals and is not legal advice. For guidance on device approvals labeling and regulatory requirements consult qualified counsel.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07405398?term=medical+device