Trial Outcomes & Findings for Effects of Drugs on Stress Memories (NCT NCT06471647)
NCT ID: NCT06471647
Last Updated: 2026-07-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
36 participants
Primary outcome timeframe
20 seconds after each cue presentation during the task
Results posted on
2026-07-09
Participant Flow
Participant milestones
| Measure |
Placebo
Dextrose capsules
Placebo: Placebo - dextrose
|
5 mg Delta-9-tetrahydrocannabinol (THC)
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC
|
10 mg Delta-9-tetrahydrocannabinol (THC)
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Drugs on Stress Memories
Baseline characteristics by cohort
| Measure |
10 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC
|
Total
n=36 Participants
Total of all reporting groups
|
5 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC
|
Placebo
n=12 Participants
Dextrose capsules
Placebo: Placebo - dextrose
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=40 Participants
|
36 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 3.9 • n=40 Participants
|
26.4 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
26.2 years
STANDARD_DEVIATION 4.1 • n=20 Participants
|
27.6 years
STANDARD_DEVIATION 5.3 • n=20 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=40 Participants
|
19 Participants
n=5 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=40 Participants
|
17 Participants
n=5 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=40 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=40 Participants
|
32 Participants
n=5 Participants
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=40 Participants
|
21 Participants
n=5 Participants
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=40 Participants
|
36 participants
n=5 Participants
|
12 participants
n=20 Participants
|
12 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 20 seconds after each cue presentation during the taskUsing 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
Outcome measures
| Measure |
5 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC
|
10 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC
|
Placebo
n=12 Participants
Dextrose capsules
Placebo: Placebo - dextrose
|
|---|---|---|---|
|
Emotional Responses After Stress Memory Cues Compared to Control Cues After Delta-9-tetrahydrocannabinol (THC) (5 mg, 10 mg) vs. Placebo
|
38.7 TSST score on visual analog scale
Standard Error 6.5
|
43.0 TSST score on visual analog scale
Standard Error 6.0
|
34.9 TSST score on visual analog scale
Standard Error 6.6
|
PRIMARY outcome
Timeframe: difference between values during 20 seconds of task cue presentationsResearchers 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.
Outcome measures
| Measure |
5 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC
|
10 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC
|
Placebo
n=12 Participants
Dextrose capsules
Placebo: Placebo - dextrose
|
|---|---|---|---|
|
Mean Physiological Responses After Stress Memory Cue Presentation Compared to Control Cues
|
97.5 milliseconds
Standard Error 2.6
|
106.1 milliseconds
Standard Error 3.3
|
110.6 milliseconds
Standard Error 5.2
|
SECONDARY outcome
Timeframe: 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 presentationUsing 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
Outcome measures
| Measure |
5 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC
|
10 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC
|
Placebo
n=12 Participants
Dextrose capsules
Placebo: Placebo - dextrose
|
|---|---|---|---|
|
Mean Emotional Responses One Week Later During Non-drug Retrieval Session
|
51.2 TSST score on visual analog scale
Standard Error 8.3
|
36.4 TSST score on visual analog scale
Standard Error 5.8
|
41.3 TSST score on visual analog scale
Standard Error 7.2
|
SECONDARY outcome
Timeframe: During 20 seconds cue presentationUsing 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.
Outcome measures
| Measure |
5 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (5): 5 mg of THC
|
10 mg Delta-9-tetrahydrocannabinol (THC)
n=12 Participants
Marinol (dronabinol)
delta-9-tetrahydrocannabinol (THC) (10): 10 mg of THC
|
Placebo
n=12 Participants
Dextrose capsules
Placebo: Placebo - dextrose
|
|---|---|---|---|
|
Mean Negative Facial Emotion Expressions During Cue Presentation After THC (5 and 10 mg) vs Placebo
|
0.13 TSST intensity score
Standard Error 0.03
|
0.19 TSST intensity score
Standard Error 0.03
|
0.30 TSST intensity score
Standard Error 0.05
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5 mg Delta-9-tetrahydrocannabinol (THC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mg Delta-9-tetrahydrocannabinol (THC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place