Actively Recruiting

Age: 18Years - 50Years
All Genders
NCT06487533

Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

Led by Spark Biomedical, Inc. · Updated on 2026-04-08

20

Participants Needed

2

Research Sites

118 weeks

Total Duration

On this page

Sponsors

S

Spark Biomedical, Inc.

Lead Sponsor

B

Battelle Memorial Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

CONDITIONS

Official Title

Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has a recent history of opioid dependence; prescription or non-prescription
  • Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
  • Participant is between 18 and 50 years of age
  • Participant is English proficient
  • Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
  • Participant is willing to wear wearable sensors for 14 days
Not Eligible

You will not qualify if you...

  • Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
  • Participant has a history of epileptic seizures
  • Participant has a history of neurological diseases or traumatic brain injury
  • Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
  • Participant has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
  • Females who are pregnant or lactating
  • Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hazelden Betty Ford Foundation

Center City, Minnesota, United States, 55012

Actively Recruiting

2

Battelle Memorial Institute

Columbus, Ohio, United States, 43201

Active, Not Recruiting

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Research Team

C

Caroline Benner

CONTACT

B

Brooke Le

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder | DecenTrialz