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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT04731935
Eligibility Criteria:
Inclusion Criteria:
* Current opioid dependence; prescriptive or non-prescriptive
* COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
* 18-65 years of age
* English proficiency
* Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements
Exclusion Criteria:
* Current evidence of an uncontrolled and/or clinically significant medical condition
* History of seizures or epilepsy
* History of neurological diseases or traumatic brain injury
* Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
* Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
* Presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators)
* Abnormal ear anatomy or ear infection present
* Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study
* Females who are pregnant or lactating
* 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:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04731935
Study Brief:
Protocol Section:
NCT04731935