Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT07085351
Brief Summary:
The US is suffering from a national opioid epidemic characterized by significant costs, overdoses, and deaths. Conventional Opioid Use Disorder (OUD) treatments (i.e., pharmacological and psychosocial interventions) are characterized by limited or diminishing efficacy, ceiling effects, and/or serious side effects. The availability of validated OUD biomarkers would be a key step in the development and approval of better treatments. Ultimately, the scarcity of OUD biomarkers represents a significant unmet need in the fight against opioid addiction as recognized by NIDA and the FDA with their support for development of Medical Device Development Tools (MDDT) and biomarker tests for OUD. Advances in neuroimaging techniques, and in particular recent evidence supports electroencephalography (EEG) as a promising candidate to investigate the correlation between addiction and brain state. To address the clear medical and market need for OUD biomarkers, this is a feasibility study to identify and assess potential EEG biomarkers for OUD diagnoses, disease monitoring, and prediction of OUD treatment response.
Detailed Description:
We will recruit up to 130 subjects for this study, with the intention of enrolling 50 OUD subjects at various stages of treatment and 20 age-matched non-OUD controls.
Eligible subjects will contact or give verbal permission to be contacted via their referring provider, by a co-investigator to obtain more information about the study. At the first point of contact (usually a phone call), study co- investigator will administer a phone-screening questionnaire. Once the phone screening process is complete, the information gathered by the co-investigator will be taken to the PI of the study for further review to confirm eligibility. Data obtained from screening will be safely stored in the PI's locked office.
Informed consent will be obtained by the study PI and/or a co-investigator (not involved in the patient's care) in person. The test procedures will be described and the testing equipment will be shown to the subject. Study co-investigators will clearly explain all the procedures and risks of the testing outlined in the consent form. The subject will be given the time needed to consider their decision and will be encouraged to ask questions, both during the initial phone interview and throughout the study. The PI or a co-investigator will answer any questions regarding the study at the time consent is given. Once enrolled, the subject may pause or terminate his/her participation at any time during the study.
Procedures Involved\* This is an observational study that includes an EEG at rest and also an EEG conducted while the subject is simultaneously completing a computer assessment. The study will have 50 OUD patients and 20 age-matched controls. Subjects will undergo EEG testing in addition to testing done concurrently with computer assessments. An additional visit will be conducted around 1 week after the initial visit. Additionally, subjects will undergo questionnaires/assessments regarding demographics, HPI, craving, mood, impulsivity, and drug use. Urine toxicology and Hair follicle (when available) will also be conducted.
Study:
NCT07085351
Study Brief:
Protocol Section:
NCT07085351