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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Dextrose capsules |
|
| 5 mg delta-9-tetrahydrocannabinol (THC) | Experimental | Marinol (dronabinol) |
|
| 10 mg delta-9-tetrahydrocannabinol (THC) | Experimental | Marinol (dronabinol) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delta-9-tetrahydrocannabinol (THC) (5) | Drug | 5 mg of THC |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harriet de Wit | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dextrose capsules Placebo: Placebo - dextrose |
| FG001 | 5 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC |
| FG002 | 10 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dextrose capsules Placebo: Placebo - dextrose |
| BG001 | 5 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | TSST score on visual analog scale | 20 seconds after each cue presentation during the task |
|
1 month, through study completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Dextrose capsules Placebo: Placebo - dextrose | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanna Molla | University of Chicago | 773-702-1234 | hmolla@uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2023 | Jun 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Placebo - dextrose |
|
| delta-9-tetrahydrocannabinol (THC) (10) | Drug | 10 mg of THC |
|
| 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 |
| BG002 | 10 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 10 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | milliseconds | difference between values during 20 seconds of task cue presentations |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | TSST score on visual analog scale | 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 |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | TSST intensity score | During 20 seconds cue presentation |
|
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 5 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 10 mg Delta-9-tetrahydrocannabinol (THC) | Marinol (dronabinol) delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC | 0 | 12 | 0 | 12 | 0 | 12 |
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