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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT06222268
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to consent to the study
* Agree to comply with requirements and procedures
* Veteran who has served in a branch of the US armed forces
* Between ages 18-60
* Report using cannabis at least once, or using cannabis no more than once a week within the past 3 months and fewer than 100 times lifetime
* Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5); trauma does not have to be related to combat or military service
* 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
* not currently receiving any psychotherapy for PTSD
Exclusion Criteria:
* Pregnant, nursing or trying to get pregnant.
* Current or past diagnosis of bipolar, schizophrenia spectrum, psychotic and related disorders
* Risk of harm to self or others that requires immediate intervention
* Current severe alcohol use or any substance use other than cannabis or nicotine
* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to smoking or vaporizing cannabis
* Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with cannabis
* Current diagnosis with hematological, endocrine, cerebrovascular, cardiovascular, systemic pulmonary, immunocompromising, or neurological disease
* Currently receiving psychotherapy for PTSD or previously received exposure-based PTSD treatment
* Current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD
* Lack of fluency in English
* Pervasive development disorder history
* Traumatic brain injury (TBI) with current cognitive impairment related to TBI
* Exclusively left-handed (score of -100 on Handedness Questionnaire)
* claustrophobic
* MRI contraindications (e.g., ferrous metal in head/body)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06222268
Study Brief:
Protocol Section:
NCT06222268