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:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT04080427
Eligibility Criteria:
Inclusion Criteria:
* Between ages 18-60
* Willing and able to consent to study
* Generally medically and neurologically healthy (including no evidence of intellectual disability or serious cognitive impairment that would interfere with task performance)
* Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5)
* Significant PTSD severity as indicated by CAPS-5 diagnosis and/or score \>= 25 of at least one month prior to study entry, PTSD is patient's primary concern
Exclusion Criteria:
* Positive urine pregnancy test prior to fMRI, self-reported current pregnancy during screening, or planning pregnancy
* Currently breastfeeding/ lactating
* MRI contraindications (e.g., ferrous metal in head/body)
* Pervasive development disorder history
* Traumatic brain injury (TBI) with current cognitive impairment related to TBI
* Risk of harm to self or others that requires immediate intervention
* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide)
* Lack of fluency in English
* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia
* Exclusively left-handed (score of -100 on Handedness Questionnaire)
* Current or past diagnosis of bipolar, schizophrenia spectrum, psychotic and related disorders
* Current severe alcohol or substance use
* Comorbid mood or anxiety disorder that is primary to PTSD
* Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with dronabinol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04080427
Study Brief:
Protocol Section:
NCT04080427