Recruiting

Observational Study

Sponsor:

OpiAID

Code:

NCT07405398

Conditions

Treatment for Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Train and evaluate the accuracy and reliability of the Strength Band Platform in identifying acute opioid dosing events from time-stamped biometric data collected from wrist-worn devices.

Study Details

Brief summary:

To train a machine learning model/algorithm for an evaluation of the use of biometric data captured at the wrist for the identification of acute opioid use events and the quantification of opioid withdrawal in opioid dependent individuals.

Conditions

Treatment for Opioid Use Disorder

Study ID

NCT07405398

Start date

May 1, 2025

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male or female
  • Age ≥22 years at signing of informed consent
  • Patients with a DSM-5 diagnosis of OUD who are eligible for MOUD induction with methadone or buprenorphine

Exclusion Criteria:

  • Sleeve tattoo covering the wrist
  • Subject unable to independently navigate and operate smartwatch applications
  • Subject not proficient with written and spoken English
  • Subject determined likely to be non-compliant by physician/HCP
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • Subject has diminished decision making capability

Study Design

Enrollment

420 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Single arm 14 day monitoring period

The goal of this real-world, multi-center, outpatient study is to train a machine learning model/algorithm utilizing patient-specific physiological parameters from the OpiAID Strength Band Platform™ can accurately detect MOUD events during the induction phase with a predefined classification success when comparing the True Positive Rate against the False Positive Rate as plotted on a Receiver Operator Curve. In addition to MOUD detection, machine learning will be used to quantify participant withdrawal level from physiological parameters. To demonstrate that withdrawal quantification performs as well or better than current measures used for this purpose the correlation between quantified withdrawal and time since last opioid dose (TSLD) will be computed and compared against the association between SOWS and TSLD in a non-inferiority analysis.

Prescribing physician must determine appropriate starting dose (titration expected over 2-6 weeks)

Interventions

Train and evaluate the accuracy and reliability of the Strength Band Platform in identifying acute opioid dosing events from time-stamped biometric data collected from wrist-worn devices.

Subjects will be fitted with the wearable device (Samsung Galaxy Watch) for the purpose of data communication and will be instructed to wear the device continuously, except when charging the watch, showering or any activity in which submersion in water is required. Participants will wear the device for 14 days.

Study subjects will be responsible for:

  • Wearing the Samsung Galaxy watch daily except when charging the watch, showering or any activity in which submersion in water is required
  • Charging the Samsung Galaxy watch daily
  • Answering prompts on the Samsung Galaxy watch
  • Answering the daily SOWS questionnaire(s)

Primary outcome measure

  • Classification [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Trace Brookins

919.355.8221trace@opiaid.tech

David Reeser

484.824.2248david@opiaid.tech

Locations

Coastal Horizon

Recruiting

Wilmington, North Carolina, United States, 28409

Contacts

David MacQueen, Ph.D

910.262.6661macqueend@uncw.edu

Rebecca Wlasiuj

rebecca@opiaid.tech

Community Medical Services

Recruiting

Austin, Texas, United States, 78745

Contacts

Joshua Luminosu

512.899.2100joshua.luminosu@cmsgiveshope.com

Principal Investigator:

Sabrie Satterwhite, PhD

Community Medical Services

Recruiting

Austin, Texas, United States, 78753

Contacts

Sabrie Satterwhite, Ph.D

512.339.9757sabrie.satterwhite@cmsgiveshope.com

Principal Investigator:

Sabrie Satterwhite, PhD

Community Medical Services

Recruiting

Cedar Park, Texas, United States, 78613

Contacts

Sherry Johnson

512.986.7743sherry.johnson@cmsgiveshope.com

Principal Investigator:

Sabrie Satterwhite, PhD

More Information

Sponsor

OpiAID

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OpiAID on 2026-02-20.