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

Launched by SPARK BIOMEDICAL, INC. · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the body reacts during opioid withdrawal and cravings in people who have an opioid use disorder. Researchers want to understand changes in certain body signals that can show how the nervous system is functioning when someone is trying to stop using opioids. The goal is to find better ways to help people going through this challenging process.

To participate in the trial, you need to be between 18 and 50 years old, currently dependent on opioids, and looking to start treatment with medications for opioid use disorder. You should be able to understand English and agree to wear special sensors for 14 days to track your body's responses. However, if you have certain medical or mental health conditions, such as a recent history of suicidal thoughts or severe illnesses, you might not qualify for the study. If you're eligible and choose to participate, you will help researchers learn more about withdrawal symptoms, which could lead to improved support and treatment options for others in the future.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Participant shows signs of current opioid dependence; prescription or non-prescription
• • 2. Participant is seeking an induction to 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