Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT05053503
Eligibility Criteria:
Inclusion Criteria
1. Participant shows signs of current opioid dependence; prescription or non-prescription
2. Participant COWS score is ≥ 8 or in the opinion of the investigator the participant is in mild to moderate withdrawal at the baseline assessment
3. Participant is between 18 and 65 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
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. Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
5. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
6. Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
7. Participant has abnormal ear anatomy or ear infection present
8. Participant is unwilling to transition to opioid antagonist medication following acute detox treatment
9. 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
10. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
11. Females who are pregnant or lactating
12. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05053503
Study Brief:
Protocol Section:
NCT05053503