Measuring physiological symptoms during opioid withdrawal and cravings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational clinical trial aims to quantify changes in physiological signals related to the autonomic nervous system in patients undergoing opioid withdrawal and cravings. It will involve 20 participants with opioid dependence who will wear the EmbracePlus Smartwatch and Corti Sensor continuously during a 14-day inpatient detoxification treatment. The study will collect data on heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels to better understand the physiological responses during this critical period.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Participant has a recent history of opioid dependence; prescription or non-prescription
2. Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
3. Participant is between 18 and 50 years of age
4. Participant is English proficient
5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
6. Participant is willing to wear wearable sensors for 14 days

Exclusion Criteria

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
2. Participant has a history of epileptic seizures
3. Participant has a history of neurological diseases or traumatic brain injury
4. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
5. Subject 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
6. Females who are pregnant or lactating
7. 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

Where it's running

• Hazelden Betty Ford Foundation
  Center City, Minnesota, United States Recruiting
• Battelle Memorial Institute
  Columbus, Ohio, United States Active not recruiting

Study contacts

• Principal investigator: Navid Khodaparast, PhD — Chief Science Officer
• Study coordinator: Caroline Benner
• Email: clinicaltrials@sparkbiomedical.com
• Phone: (210) 624-8046

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using buspirone to help with opioid withdrawal

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• Evaluating opioid withdrawal symptoms during medication tapering

  This study is testing how different people experience withdrawal symptoms when they slowly reduce their opioid use under medical supervision to help improve treatment for opioid use disorder.

  Recruiting Phase 2 University of Maryland, Baltimore · Baltimore, Maryland · NCT05027919

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.