Clinical trial NCT06471647: Effects of Drugs on Stress Memories
Official title: Effects of Drugs on Stress Memories
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Delta-9-tetrahydrocannabinol (THC)
Stress
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.

Detailed description: The current study will use a between subject, randomized, placebo-controlled design to assess the effects of low doses of delta-9-tetrahydrocannabinol (THC) on stress memories. Healthy male and female participants (N=48) will be randomly assigned to one of the three drug conditions (5 mg THC \[n=16\], 10 mg THC \[n=16\], or placebo \[n=16\]). Each subject will participate in 3 sessions. In the first session, they will undergo the TSST procedure. Researchers will obtain ratings of subjective distress, heart rate variability, and cortisol levels to assess response to the stressor for each individual. On the second session, one week later, participants will receive either THC or placebo and they will then be presented with TSST-related cues during a stress-memory retrieval session.

Eligibility criteria: Inclusion Criteria:

* 18-35 y/o
* BMI 19-29 kg/m2
* some prior experience with cannabis (used at least 4 times, no adverse experiences, and current use no more than once a week)

Exclusion Criteria:

* Current severe substance use disorder
* history of psychosis or mania
* Lack of English fluency
* Current DSM IV Axis I disorder
* Abnormal EKG
* Daily use of medications outside of contraception,
* Women who are pregnant or trying to become pregnant

Primary outcomes:
measure: Change in emotional responses after stress memory cues compared to control cues after delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. placebo
timeFrame: baseline (5 minutes before memory task) and 20 seconds after each cue presentation during the task
measure: Change in physiological responses after stress memory cue presentation compared to control cues
timeFrame: difference between values at baseline (5 minutes pre-task) and during 20 seconds of task cue presentations
Secondary outcomes:
measure: Change in emotional responses one week later during non-drug retrieval session
timeFrame: 1 week after the first exposure they will complete the memory task again. The timeframe for assessing changes in emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation
measure: Change in negative facial emotion expressions during cue presentation after THC (5 and 10 mg) vs placebo
timeFrame: During 20 seconds cue presentation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit
role: PRINCIPAL_INVESTIGATOR
References: