NCT06487533 Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
| NCT ID | NCT06487533 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spark Biomedical, Inc. |
| Condition | Opioid Withdrawal |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-19 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-02-19 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Navid Khodaparast, PhD
PRINCIPAL INVESTIGATOR
Chief Science Officer
Frequently Asked Questions
Who can join the NCT06487533 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Opioid Withdrawal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06487533 currently recruiting?
Yes, NCT06487533 is actively recruiting participants. Contact the research team at clinicaltrials@sparkbiomedical.com for enrollment information.
Where is the NCT06487533 trial being conducted?
This trial is being conducted at Center City, United States, Columbus, United States.
Who is sponsoring the NCT06487533 clinical trial?
NCT06487533 is sponsored by Spark Biomedical, Inc.. The principal investigator is Navid Khodaparast, PhD at Chief Science Officer. The trial plans to enroll 20 participants.