Effects of Drugs on Stress Memories (ETS)

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.

Study Overview

• Status: Completed
• Conditions: Stress; Delta-9-tetrahydrocannabinol (THC)
• Intervention / Treatment: Drug: Placebo; Drug: delta-9-tetrahydrocannabinol (THC) (5); Drug: delta-9-tetrahydrocannabinol (THC) (10)

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Dextrose capsules	Drug: Placebo; Placebo - dextrose
Experimental: 5 mg delta-9-tetrahydrocannabinol (THC); Marinol (dronabinol)	Drug: delta-9-tetrahydrocannabinol (THC) (5); 5 mg of THC
Experimental: 10 mg delta-9-tetrahydrocannabinol (THC); Marinol (dronabinol)	Drug: delta-9-tetrahydrocannabinol (THC) (10); 10 mg of THC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo	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	20 seconds after each cue presentation during the task
Mean Physiological Responses After Stress Memory Cue Presentation Compared to Control Cues	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.	difference between values during 20 seconds of task cue presentations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Emotional Responses One Week Later During Non-drug Retrieval Session	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	1 week after the first exposure they will complete the memory task again. The timeframe for assessing mean emotional responses will be at baseline (5 minutes pre-memory task) and 20 seconds after each cue presentation
Mean Negative Facial Emotion Expressions During Cue Presentation After THC (5 and 10 mg) vs Placebo	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.	During 20 seconds cue presentation

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Harriet de Wit, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): March 25, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: IRB23-1534

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes