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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT02069366
Eligibility Criteria:
Inclusion Criteria for All Participants:
* Able to give informed consent
* Physically and neurologically healthy \[confirmed by a comprehensive medical history\]
* Age between 21-45 years old
* Right-handed
Inclusion Criteria for Participants with PTSD:
* Current PTSD diagnosis \[related to civilian trauma\]
Inclusion Criteria for Trauma-Exposed Participants without PTSD:
* Experience with a civilian trauma without a PTSD diagnosis
* Free of a lifetime Axis I or Axis II diagnosis
Inclusion Criteria for Non-Trauma-Exposed Healthy Participants:
* Free of a lifetime Axis I or Axis II diagnosis
Exclusion Criteria for All Participants:
* Clinically significant medical or neurological condition
* Less than a high school education
* Lack of fluency in English
* Night shift work
* Currently pregnant; planning pregnancy; or lactating
* Unwilling/unable to sign informed consent document
* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia)
* Left-handed
* Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
* Under 21 or over 45 years of age
* Anticipation of a required drug test in the 4 weeks following study participation
* Positive urine drug screen and/or alcohol breathalyzer
* Current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances \[dronabinol/marijuana/cannabis/thc, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide\]
* Participation in an experiment involving white noise bursts or shocks in the last 6 months
Exclusion Criteria for Participants with PTSD:
* Primary comorbid anxiety disorder (defined by which disorder was the more debilitating and clinically salient)
* Life history of bipolar disorder, schizophrenia, or presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
* Current or in the past 6 months alcohol/drug abuse of dependence
* Current or in the past 6 months major depressive disorder
* Current suicidal ideation
* Diagnosis of an Axis II personality disorder
* Concomitant treatments with psychotropic/psychoactive medication \[including beta-adrenergic blockers, selective serotonin reuptake inhibitor (SSRI), benzodiazepines, tricyclic or monoamine oxidase inhibitor (MAOI) antidepressants, lithium, antiepileptic/anticonvulsants, neuroleptics/antipsychotics, etc.) or in the past two weeks \[8 weeks for fluoxetine and 4 weeks for MAOIs) before screening (Visit 1)
* currently receiving exposure-based therapy for PTSD
Exclusion Criteria for Trauma-Exposed Participants without PTSD and Non-Trauma Exposed Healthy Participants:
* Current or past Axis I psychiatric disorder \[including alcohol/substance abuse of dependence disorder\]
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT02069366
Study Brief:
Protocol Section:
NCT02069366