MedPath

Effects of Drugs on Stress Memories

Early Phase 1
Recruiting
Conditions
Delta-9-tetrahydrocannabinol (THC)
Stress
Interventions
Registration Number
NCT06471647
Lead Sponsor
University of Chicago
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
placeboPlaceboDextrose capsules
5 mg delta-9-tetrahydrocannabinol (THC)delta-9-tetrahydrocannabinol (THC) (5)Marinol (dronabinol)
10 mg delta-9-tetrahydrocannabinol (THC)delta-9-tetrahydrocannabinol (THC) (10)Marinol (dronabinol)
Primary Outcome Measures
NameTimeMethod
Change in emotional responses after stress memory cues compared to control cues after delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. placebobaseline (5 minutes before memory task) and 20 seconds after each cue presentation during the task

Using a visual analog scale participants will rate feelings of 'distress' 'arousal' and 'valence'. Scores range from 0-100 with higher scores indicating greater responses on particular items

Change in physiological responses after stress memory cue presentation compared to control cuesdifference between values at baseline (5 minutes pre-task) and during 20 seconds of task cue presentations

Researchers will assess changes in cardiac output (pre-ejection period) after presentation of cues. This will be measured in milliseconds. Lower values indicate greater sympathetic activation.

Secondary Outcome Measures
NameTimeMethod
Change in negative facial emotion expressions during cue presentation after THC (5 and 10 mg) vs placeboDuring 20 seconds cue presentation

Using facial expression model, researchers will assess changes in the intensity (0-1) of negative facial emotions during presentation of memory cues, comparing control vs. stress memory cues. higher values indicate greater intensity.

Change in emotional responses one week later during non-drug retrieval session1 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

Using a visual analog scale from 0-100 participants will rate feelings of 'distress' 'arousal' and 'valence' in a non-drug state. Scores range from 0-100 with higher scores indicating greater responses on particular items

Trial Locations

Locations (1)

University of Chicago

🇺🇸

Chicago, Illinois, United States

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