Status:
COMPLETED
Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain...
Detailed Description
The total time commitment estimated per participant 18 study visits. This is broken down below: Visit 1: Questionnaires, Screening, and Orientation: During this visit the potential participant will l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04080427
Start Date
April 15 2021
End Date
May 31 2025
Last Update
July 11 2025
Active Locations (1)
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1
Eugene Applebaum College of Pharmacy and Health Sciences
Detroit, Michigan, United States, 48201