Measuring physiological symptoms during opioid withdrawal and cravings
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
This study is testing how the body reacts during opioid withdrawal and cravings in people with opioid dependence by using smartwatches to track their heart rate, skin temperature, and other signals over two weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Spark Biomedical, Inc. Industry-sponsored |
| Locations | 2 sites (Center City, Minnesota and 1 other locations) |
| Trial ID | NCT06487533 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 who are currently dependent on opioids and seeking medication-assisted treatment.
Not a fit: Patients with uncontrolled medical or psychiatric conditions, a history of seizures, or significant suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of opioid withdrawal symptoms, enhancing treatment outcomes for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using wearable technology to monitor physiological responses in addiction treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Center City, Minnesota and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.