Effects of Drugs on Stress Memories

NCT06471647 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB23-1534
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Delta-9-tetrahydrocannabinol (THC); Stress

Outcome Measures

Primary Outcomes (2)

• Change in 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

  baseline (5 minutes before memory task) and 20 seconds after each cue presentation during the task

• Change in 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 at baseline (5 minutes pre-task) and during 20 seconds of task cue presentations

Secondary Outcomes (2)

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

  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

• Change in negative facial emotion expressions during cue presentation after THC (5 and 10 mg) vs placebo

  During 20 seconds cue presentation

Study Arms (3)

placebo

PLACEBO COMPARATOR

Dextrose capsules

Drug: Placebo

5 mg delta-9-tetrahydrocannabinol (THC)

EXPERIMENTAL

Marinol (dronabinol)

Drug: delta-9-tetrahydrocannabinol (THC) (5)

10 mg delta-9-tetrahydrocannabinol (THC)

EXPERIMENTAL

Marinol (dronabinol)

Drug: delta-9-tetrahydrocannabinol (THC) (10)

Interventions

delta-9-tetrahydrocannabinol (THC) (5) DRUG

5 mg of THC

5 mg delta-9-tetrahydrocannabinol (THC)

Placebo DRUG

Placebo - dextrose

placebo

delta-9-tetrahydrocannabinol (THC) (10) DRUG

10 mg of THC

10 mg delta-9-tetrahydrocannabinol (THC)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Harriet de Wit

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

US (1)