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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT05903495
Eligibility Criteria:
Inclusion Criteria:
* Age 22-50 years at time of enrollment.
* Fulfills current DSM-5 diagnostic criteria for severe OUD with at least a 5-year history.
* Participants may have comorbid SUD diagnoses at a mild, moderate or severe level, however, OUD must be the primary disorder for which the individual is seeking treatment and the other use disorders must occur in the context of relapse.
* At least one lifetime overdose survival.
* Demonstrated greater than five years of refractory symptoms of OUD.
Exclusion Criteria:
* Diagnosis of acute myocardial infarction or cardiac arrest 1 within the previous 6 months.
* Past or present diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced.
* Unable to undergo MR-imaging
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
50 Years
Study:
NCT05903495
Study Brief:
Protocol Section:
NCT05903495