Status:
NOT_YET_RECRUITING
Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery
Lead Sponsor:
Wayne State University
Conditions:
PTSD
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depre...
Detailed Description
The total time commitment estimated per participant 21 study visits. This is broken down below: Visit 1: Pre-Screening and informed Consent: During this visit the potential participant will learn abo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06222268
Start Date
August 1 2025
End Date
September 1 2027
Last Update
August 6 2025
Active Locations (3)
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1
Tolan Park Medical Building
Detroit, Michigan, United States, 48201
2
Wayne State University Eugene Applebaum College of Pharmacy & Health Sciences
Detroit, Michigan, United States, 48201
3
WSU MR Research Facility DMC Harper University Hospital
Detroit, Michigan, United States, 48201