Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Diso… (NCT06487533) | Clinical Trial Compass
RecruitingNot Applicable
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
United States20 participantsStarted 2025-02-19
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Timeframe: Daily throughout the 14-day inpatient detoxification treatment
2
Clinical Opioid Withdrawal Scale (COWS)
Timeframe: Daily throughout the 14-day inpatient detoxification treatment
3
Opioid Craving Visual Analog Scale (OC-VAS)
Timeframe: Daily throughout the 14-day inpatient detoxification treatment
4
Adverse Events
Timeframe: Daily throughout the 14-day inpatient detoxification treatment
. 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
. 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