Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 that is involved in these processes and how this relates to the treatment of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Dronabinol

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