Effects of THC on Memory Retention in PTSD

Effects of THC on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

This study is testing if THC can help people with PTSD improve their memory and reactions to fear by looking at their brain activity and behavior before and after using it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Wayne State University (other)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT04080427 on ClinicalTrials.gov

What this trial studies

This study investigates how Delta9-tetrahydrocannabinol (THC), a cannabinoid, influences the processing of fear signals and emotional responses in individuals with Posttraumatic Stress Disorder (PTSD). Participants will undergo a series of behavioral tests and MRI scans to assess their reactions to fear-related stimuli before and after THC administration. The study aims to understand the relationship between THC and memory retention related to fear extinction learning, potentially leading to new treatment options for PTSD. A total of 18 visits are planned for each participant, involving screenings, behavioral assessments, and MRI evaluations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a confirmed diagnosis of PTSD and significant symptom severity.

Not a fit: Patients with contraindications for MRI or those currently pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to innovative treatments for individuals suffering from PTSD, improving their ability to manage fear and anxiety.

How similar studies have performed: While cannabinoid effects on PTSD are being explored, this specific approach focusing on THC's role in memory retention during fear extinction is relatively novel.

Eligibility 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

Where this trial is running

Detroit, Michigan

• Eugene Applebaum College of Pharmacy and Health Sciences — Detroit, Michigan, United States (RECRUITING)

Study contacts

• Principal investigator: Christine A Rabinak, PhD — Wayne State University
• Study coordinator: Sarah Durack

Conditions: Posttraumatic Stress Disorder