Trial Outcomes & Findings for Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder (NCT NCT02069366)
NCT ID: NCT02069366
Last Updated: 2025-10-02
Results Overview
Mean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests \[amygdala; ventromedial prefrontal cortex; hippocampus\] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
Brain measures are collected on Visit 3, 14 days from baseline (Visit 1) and Visit 4, 15 days from baseline (Visit 1), for approximately 1.5 hours each day
Results posted on
2025-10-02
Participant Flow
Participant milestones
| Measure |
PTSD-dronabinol
Trauma exposed individuals with PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
PTSD-placebo
Trauma exposed individuals with PTSD that received a one-time oral dose of placebo
|
TEC-dronabinol
Trauma exposed individuals without PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
TEC-placebo
Trauma exposed individuals without PTSD that received a one-time oral dose of placebo
|
HC-dronabinol
Non-trauma exposed individuals that received a one-time oral dose of dronabinol (7.5mg)
|
HC-placebo
Non-trauma exposed individuals that received a one-time oral dose of placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
18
|
17
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
10
|
15
|
15
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
PTSD-dronabinol
Trauma exposed individuals with PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
PTSD-placebo
Trauma exposed individuals with PTSD that received a one-time oral dose of placebo
|
TEC-dronabinol
Trauma exposed individuals without PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
TEC-placebo
Trauma exposed individuals without PTSD that received a one-time oral dose of placebo
|
HC-dronabinol
Non-trauma exposed individuals that received a one-time oral dose of dronabinol (7.5mg)
|
HC-placebo
Non-trauma exposed individuals that received a one-time oral dose of placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
PTSD-dronabinol
n=13 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
PTSD-placebo
n=10 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of placebo
|
TEC-dronabinol
n=18 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
TEC-placebo
n=17 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of placebo
|
HC-dronabinol
n=14 Participants
Non-trauma-exposed individuals that received a one-time oral dose of dronabinol (7.5mg)
|
HC-placebo
n=14 Participants
Non-trauma-exposed individuals that received a one-time oral dose of placebo
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
86 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
25.69 years
STANDARD_DEVIATION 4.91 • n=5 Participants
|
23.40 years
STANDARD_DEVIATION 2.91 • n=7 Participants
|
28.94 years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
26.59 years
STANDARD_DEVIATION 6.83 • n=4 Participants
|
24.29 years
STANDARD_DEVIATION 2.46 • n=21 Participants
|
25.79 years
STANDARD_DEVIATION 4.77 • n=8 Participants
|
26.07 years
STANDARD_DEVIATION 5.65 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
14 participants
n=21 Participants
|
14 participants
n=8 Participants
|
86 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Brain measures are collected on Visit 3, 14 days from baseline (Visit 1) and Visit 4, 15 days from baseline (Visit 1), for approximately 1.5 hours each dayMean functional magnetic resonance imaging (fMRI) BOLD activation extracted from each region of interests \[amygdala; ventromedial prefrontal cortex; hippocampus\] for each stimulus type (CS+E, CS+U, CS-). The units of BOLD values are expressed as arbitrary units.
Outcome measures
| Measure |
PTSD-dronabinol
n=12 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
PTSD-placebo
n=10 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of placebo
|
TEC-dronabinol
n=15 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
TEC-placebo
n=15 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of placebo
|
HC-dronabinol
n=14 Participants
Non-trauma-exposed individuals that received a one-time oral dose of dronabinol (7.5mg)
|
HC-placebo
n=12 Participants
Non-trauma-exposed individuals that received a one-time oral dose of placebo
|
|---|---|---|---|---|---|---|
|
Brain Measures
Recall CS- vmPFC-Visit 4
|
-0.15 arbitrary units
Standard Deviation 0.19
|
-0.05 arbitrary units
Standard Deviation 0.16
|
-0.20 arbitrary units
Standard Deviation 0.21
|
-0.16 arbitrary units
Standard Deviation 0.19
|
-0.12 arbitrary units
Standard Deviation 0.18
|
-0.10 arbitrary units
Standard Deviation 0.19
|
|
Brain Measures
Extinction Learning CS- vmPFC- Visit 3
|
-0.10 arbitrary units
Standard Deviation 0.16
|
-0.23 arbitrary units
Standard Deviation 0.13
|
-0.16 arbitrary units
Standard Deviation 0.19
|
-0.10 arbitrary units
Standard Deviation 0.13
|
-0.17 arbitrary units
Standard Deviation 0.23
|
-0.17 arbitrary units
Standard Deviation 0.21
|
|
Brain Measures
Recall CS+E Hippocampus-Visit 4
|
0.05 arbitrary units
Standard Deviation 0.12
|
-0.02 arbitrary units
Standard Deviation 0.15
|
0.04 arbitrary units
Standard Deviation 0.13
|
0.01 arbitrary units
Standard Deviation 0.18
|
0.0 arbitrary units
Standard Deviation 0.17
|
0.0 arbitrary units
Standard Deviation 0.26
|
|
Brain Measures
Recall CS+E vmPFC-Visit 4
|
-0.19 arbitrary units
Standard Deviation 0.26
|
-0.06 arbitrary units
Standard Deviation 0.12
|
-0.08 arbitrary units
Standard Deviation 0.14
|
-0.14 arbitrary units
Standard Deviation 0.26
|
-0.11 arbitrary units
Standard Deviation 0.22
|
-0.19 arbitrary units
Standard Deviation 0.28
|
|
Brain Measures
Recall CS- Amygdala-Visit 4
|
0.14 arbitrary units
Standard Deviation 0.36
|
0.18 arbitrary units
Standard Deviation 0.41
|
0.01 arbitrary units
Standard Deviation 0.20
|
-0.02 arbitrary units
Standard Deviation 0.20
|
0.16 arbitrary units
Standard Deviation 0.15
|
0.20 arbitrary units
Standard Deviation 0.31
|
|
Brain Measures
Recall CS- Hippocampus-Visit 4
|
0.02 arbitrary units
Standard Deviation 0.20
|
0.0 arbitrary units
Standard Deviation 0.23
|
-0.04 arbitrary units
Standard Deviation 0.07
|
-0.02 arbitrary units
Standard Deviation 0.12
|
0.04 arbitrary units
Standard Deviation 0.14
|
0.09 arbitrary units
Standard Deviation 0.19
|
|
Brain Measures
Extinction Learning CS+E Amygdala- Visit 3
|
-0.08 arbitrary units
Standard Deviation 0.23
|
0.27 arbitrary units
Standard Deviation 0.27
|
0.02 arbitrary units
Standard Deviation 0.21
|
0.03 arbitrary units
Standard Deviation 0.27
|
-0.05 arbitrary units
Standard Deviation 0.28
|
-0.09 arbitrary units
Standard Deviation 0.30
|
|
Brain Measures
Extinction Learning CS+E Hippocampus- Visit 3
|
-0.06 arbitrary units
Standard Deviation 0.12
|
-0.03 arbitrary units
Standard Deviation 0.13
|
-0.07 arbitrary units
Standard Deviation 0.09
|
-0.06 arbitrary units
Standard Deviation 0.15
|
-0.05 arbitrary units
Standard Deviation 0.08
|
-0.14 arbitrary units
Standard Deviation 0.23
|
|
Brain Measures
Extinction Learning CS- Hippocampus- Visit 3
|
-0.04 arbitrary units
Standard Deviation 0.19
|
-0.05 arbitrary units
Standard Deviation 0.11
|
-0.04 arbitrary units
Standard Deviation 0.16
|
-0.01 arbitrary units
Standard Deviation 0.12
|
-0.07 arbitrary units
Standard Deviation 0.16
|
-0.14 arbitrary units
Standard Deviation 0.20
|
|
Brain Measures
Recall CS+U vmPFC-Visit 4
|
-0.18 arbitrary units
Standard Deviation 0.25
|
-0.08 arbitrary units
Standard Deviation 0.21
|
-0.24 arbitrary units
Standard Deviation 0.23
|
-0.20 arbitrary units
Standard Deviation 0.17
|
-0.14 arbitrary units
Standard Deviation 0.21
|
-0.16 arbitrary units
Standard Deviation 0.28
|
|
Brain Measures
Renewal CS+E Amygdala-Visit 4
|
0.16 arbitrary units
Standard Deviation 0.21
|
0.19 arbitrary units
Standard Deviation 0.43
|
0.13 arbitrary units
Standard Deviation 0.23
|
0.06 arbitrary units
Standard Deviation 0.24
|
0.10 arbitrary units
Standard Deviation 0.17
|
0.07 arbitrary units
Standard Deviation 0.32
|
|
Brain Measures
Recall CS+E Amygdala- Visit 4
|
0.20 arbitrary units
Standard Deviation 0.24
|
0.10 arbitrary units
Standard Deviation 0.33
|
0.11 arbitrary units
Standard Deviation 0.19
|
0.03 arbitrary units
Standard Deviation 0.32
|
0.01 arbitrary units
Standard Deviation 0.12
|
-0.01 arbitrary units
Standard Deviation 0.33
|
|
Brain Measures
Extinction Learning CS+E vmPFC- Visit 3
|
-0.11 arbitrary units
Standard Deviation 0.15
|
-0.22 arbitrary units
Standard Deviation 0.19
|
-0.12 arbitrary units
Standard Deviation 0.21
|
-0.14 arbitrary units
Standard Deviation 0.19
|
-0.18 arbitrary units
Standard Deviation 0.16
|
-0.21 arbitrary units
Standard Deviation 0.18
|
|
Brain Measures
Extinction Learning CS- Amygdala- Visit 3
|
-0.01 arbitrary units
Standard Deviation 0.34
|
0.19 arbitrary units
Standard Deviation 0.22
|
0.07 arbitrary units
Standard Deviation 0.23
|
0.04 arbitrary units
Standard Deviation 0.22
|
0.02 arbitrary units
Standard Deviation 0.28
|
-0.07 arbitrary units
Standard Deviation 0.31
|
|
Brain Measures
Recall CS+U Amygdala-Visit 4
|
0.12 arbitrary units
Standard Deviation 0.23
|
0.14 arbitrary units
Standard Deviation 0.20
|
0.14 arbitrary units
Standard Deviation 0.24
|
-0.06 arbitrary units
Standard Deviation 0.24
|
0.09 arbitrary units
Standard Deviation 0.19
|
0.06 arbitrary units
Standard Deviation 0.21
|
|
Brain Measures
Recall CS+U Hippocampus-Visit 4
|
-0.04 arbitrary units
Standard Deviation 0.11
|
-0.05 arbitrary units
Standard Deviation 0.15
|
-0.02 arbitrary units
Standard Deviation 0.11
|
-0.05 arbitrary units
Standard Deviation 0.10
|
0 arbitrary units
Standard Deviation 0.19
|
0 arbitrary units
Standard Deviation 0.15
|
|
Brain Measures
Renewal CS+E Hippocampus- Visit 4
|
0.11 arbitrary units
Standard Deviation 0.08
|
0.06 arbitrary units
Standard Deviation 0.25
|
0.04 arbitrary units
Standard Deviation 0.07
|
0.04 arbitrary units
Standard Deviation 0.13
|
0.03 arbitrary units
Standard Deviation 0.18
|
0.04 arbitrary units
Standard Deviation 0.15
|
|
Brain Measures
Renewal CS+E vmPFC- Visit 4
|
0.0 arbitrary units
Standard Deviation 0.20
|
-0.09 arbitrary units
Standard Deviation 0.22
|
-0.14 arbitrary units
Standard Deviation 0.18
|
-0.12 arbitrary units
Standard Deviation 0.29
|
-0.08 arbitrary units
Standard Deviation 0.2
|
-0.08 arbitrary units
Standard Deviation 0.19
|
|
Brain Measures
Renewal CS- Amygdala- Visit 4
|
0.04 arbitrary units
Standard Deviation 0.15
|
0.25 arbitrary units
Standard Deviation 0.36
|
-0.10 arbitrary units
Standard Deviation 0.21
|
-0.02 arbitrary units
Standard Deviation 0.37
|
0.04 arbitrary units
Standard Deviation 0.18
|
0.19 arbitrary units
Standard Deviation 0.31
|
|
Brain Measures
Renewal CS- Hippocampus-Visit 4
|
0.02 arbitrary units
Standard Deviation 0.12
|
0.06 arbitrary units
Standard Deviation 0.19
|
-0.03 arbitrary units
Standard Deviation 0.08
|
0.01 arbitrary units
Standard Deviation 0.22
|
0.06 arbitrary units
Standard Deviation 0.08
|
0.05 arbitrary units
Standard Deviation 0.16
|
|
Brain Measures
Renewal CS- vmPFC-Visit 4
|
-0.10 arbitrary units
Standard Deviation 0.26
|
-0.05 arbitrary units
Standard Deviation 0.20
|
-0.14 arbitrary units
Standard Deviation 0.22
|
-0.15 arbitrary units
Standard Deviation 0.20
|
-0.10 arbitrary units
Standard Deviation 0.20
|
-0.12 arbitrary units
Standard Deviation 0.25
|
|
Brain Measures
Renewal CS+U Amygdala-Visit 4
|
0.05 arbitrary units
Standard Deviation 0.18
|
0.22 arbitrary units
Standard Deviation 0.31
|
0.09 arbitrary units
Standard Deviation 0.22
|
0.09 arbitrary units
Standard Deviation 0.31
|
0.03 arbitrary units
Standard Deviation 0.32
|
-0.04 arbitrary units
Standard Deviation 0.30
|
|
Brain Measures
Renewal CS+U Hippocampus-Visit 4
|
0.01 arbitrary units
Standard Deviation 0.13
|
0.06 arbitrary units
Standard Deviation 0.16
|
0.09 arbitrary units
Standard Deviation 0.11
|
0.06 arbitrary units
Standard Deviation 0.11
|
-0.01 arbitrary units
Standard Deviation 0.16
|
-0.05 arbitrary units
Standard Deviation 0.21
|
|
Brain Measures
Renewal CS+U vmPFC-Visit 4
|
-0.20 arbitrary units
Standard Deviation 0.22
|
-0.07 arbitrary units
Standard Deviation 0.20
|
-0.04 arbitrary units
Standard Deviation 0.19
|
-0.12 arbitrary units
Standard Deviation 0.19
|
-0.15 arbitrary units
Standard Deviation 0.17
|
-0.18 arbitrary units
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: Collected on Visit 2, 13 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), and Visit 4, 15 days from baseline, during the task. Each day the task lasted approximately 20 minutes.Population: The number analyzed in each row may differ from the overall number analyzed due to missing data.
To assess the expected likelihood that an aversive cue (e.g. noise burst) will occur or not based on the CS shown on the screen. Participants rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 \[1 = certain that the aversive cue will be presented (Yes); 2 = certain that the aversive cue will not be presented (No); 3 = uncertain whether the aversive cue will be presented (I don't know)\]. Counts of "yes", "no", and "I don't know" are collected on the first (early) trial of the CS and the last (late) trial of the CS.
Outcome measures
| Measure |
PTSD-dronabinol
n=12 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
PTSD-placebo
n=10 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of placebo
|
TEC-dronabinol
n=15 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
TEC-placebo
n=15 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of placebo
|
HC-dronabinol
n=14 Participants
Non-trauma-exposed individuals that received a one-time oral dose of dronabinol (7.5mg)
|
HC-placebo
n=12 Participants
Non-trauma-exposed individuals that received a one-time oral dose of placebo
|
|---|---|---|---|---|---|---|
|
Expectancy Ratings
Acquisition CS-Early- Visit 2 · No
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
|
Expectancy Ratings
Acquisition CS-Early- Visit 2 · I don't know
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Acquisition CS+E Early- Visit 2 · No
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+U Early- Visit 2 · No
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Expectancy Ratings
Acquisition CS-Early- Visit 2 · Yes
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+U Late- Visit 2 · I don't know
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Expectancy Ratings
Acquisition CS+U Late- Visit 2 · Yes
|
4 Participants
|
6 Participants
|
7 Participants
|
11 Participants
|
5 Participants
|
10 Participants
|
|
Expectancy Ratings
Acquisition CS+E Late- Visit 2 · Yes
|
6 Participants
|
6 Participants
|
7 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
|
Expectancy Ratings
Extinction CS+E Late-Visit 3 · No
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
10 Participants
|
5 Participants
|
|
Expectancy Ratings
Extinction CS+E Late-Visit 3 · I don't know
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Extinction CS+E Late-Visit 3 · Yes
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
|
Expectancy Ratings
Extinction CS- Late- Visit 3 · No
|
5 Participants
|
9 Participants
|
9 Participants
|
13 Participants
|
9 Participants
|
6 Participants
|
|
Expectancy Ratings
Extinction CS- Late- Visit 3 · I don't know
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Acquisition CS+E Early- Visit 2 · I don't know
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Acquisition CS+E Early- Visit 2 · Yes
|
6 Participants
|
7 Participants
|
7 Participants
|
12 Participants
|
9 Participants
|
8 Participants
|
|
Expectancy Ratings
Extinction CS- Late- Visit 3 · Yes
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 4 · No
|
3 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Expectancy Ratings
Acquisition CS+U Early- Visit 2 · I don't know
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 4 · I don't know
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 4 · Yes
|
3 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Expectancy Ratings
Acquisition CS+U Early- Visit 2 · Yes
|
5 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
5 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 4 · No
|
4 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 4 · I don't know
|
4 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 4 · Yes
|
1 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 4 · No
|
3 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 4 · I don't know
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 4 · Yes
|
2 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 4 · No
|
7 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 4 · I don't know
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 4 · Yes
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 4 · No
|
4 Participants
|
5 Participants
|
11 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+E Late- Visit 2 · No
|
1 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 4 · I don't know
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 4 · Yes
|
3 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 4 · No
|
6 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 4 · I don't know
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 4 · Yes
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 4 · No
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Expectancy Ratings
Acquisition CS+E Late- Visit 2 · I don't know
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 4 · I don't know
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Expectancy Ratings
Acquisition CS+U Late- Visit 2 · No
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 4 · Yes
|
3 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 4 · No
|
4 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Expectancy Ratings
Acquisition CS- Late- Visit 2 · No
|
7 Participants
|
8 Participants
|
8 Participants
|
13 Participants
|
11 Participants
|
10 Participants
|
|
Expectancy Ratings
Acquisition CS- Late- Visit 2 · I don't know
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 4 · I don't know
|
1 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Expectancy Ratings
Acquisition CS- Late- Visit 2 · Yes
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 4 · Yes
|
4 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 4 · No
|
8 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
|
Expectancy Ratings
Extinction CS+E Early- Visit 3 · No
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 4 · I don't know
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Extinction CS+E Early- Visit 3 · I don't know
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Expectancy Ratings
Extinction CS+E Early- Visit 3 · Yes
|
7 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 4 · No
|
7 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Expectancy Ratings
Extinction CS- Early- Visit 3 · No
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 4 · I don't know
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Extinction CS- Early- Visit 3 · I don't know
|
1 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Expectancy Ratings
Extinction CS- Early- Visit 3 · Yes
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 4 · Yes
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 4 · No
|
5 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 4 · I don't know
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 4 · Yes
|
2 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 4 · No
|
6 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
8 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 4 · I don't know
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 4 · Yes
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: SUDS ratings are collected at Visit 3 (Day 14 from baseline) and Visit 4 (Day 15 from baseline), at three timepoints per visit: before the task (Pre), midpoint (Mid), and after the task (Post), each averaged over ~1 minute.Subjective Units of Distress (SUDS): used to measure fear ratings/"subjective" anxiety on a scale from 0-10; taken at three time points throughout the tasks: before the task begins, in the middle of the task, and at the end of the task. A rating of "0" means no anxiety and a ratings of "10" means worst anxiety ever experienced.
Outcome measures
| Measure |
PTSD-dronabinol
n=12 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
PTSD-placebo
n=10 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of placebo
|
TEC-dronabinol
n=15 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of dronabinol (7.5mg)
|
TEC-placebo
n=15 Participants
Trauma-exposed individuals without PTSD that received a one-time oral dose of placebo
|
HC-dronabinol
n=14 Participants
Non-trauma-exposed individuals that received a one-time oral dose of dronabinol (7.5mg)
|
HC-placebo
n=12 Participants
Non-trauma-exposed individuals that received a one-time oral dose of placebo
|
|---|---|---|---|---|---|---|
|
Subjective Units of Distress (SUDS)
Extinction Learning Pre- Visit 3
|
3.44 score on a scale
Standard Deviation 2.7
|
2.5 score on a scale
Standard Deviation 1.58
|
2.83 score on a scale
Standard Deviation 1.95
|
1.79 score on a scale
Standard Deviation 2.29
|
3.15 score on a scale
Standard Deviation 2.03
|
1.92 score on a scale
Standard Deviation 1.32
|
|
Subjective Units of Distress (SUDS)
Extinction Learning Mid-Visit 3
|
4.22 score on a scale
Standard Deviation 2.82
|
2.90 score on a scale
Standard Deviation 2.38
|
3.50 score on a scale
Standard Deviation 2.54
|
1.50 score on a scale
Standard Deviation 1.56
|
3.00 score on a scale
Standard Deviation 2.58
|
2.23 score on a scale
Standard Deviation 2.20
|
|
Subjective Units of Distress (SUDS)
Extinction Learning Post-Visit 3
|
3.56 score on a scale
Standard Deviation 2.55
|
2.20 score on a scale
Standard Deviation 1.87
|
2.75 score on a scale
Standard Deviation 2.42
|
1.64 score on a scale
Standard Deviation 2.06
|
3.23 score on a scale
Standard Deviation 2.52
|
2.31 score on a scale
Standard Deviation 2.39
|
|
Subjective Units of Distress (SUDS)
Recall Pre-Visit 4
|
1.22 score on a scale
Standard Deviation 0.97
|
2.00 score on a scale
Standard Deviation 2.26
|
0.92 score on a scale
Standard Deviation 1.44
|
0.50 score on a scale
Standard Deviation 1.40
|
1.46 score on a scale
Standard Deviation 1.94
|
1.00 score on a scale
Standard Deviation 1.47
|
|
Subjective Units of Distress (SUDS)
Recall Mid-Visit 4
|
2.00 score on a scale
Standard Deviation 1.87
|
2.20 score on a scale
Standard Deviation 1.99
|
1.42 score on a scale
Standard Deviation 2.31
|
0.64 score on a scale
Standard Deviation 1.39
|
1.46 score on a scale
Standard Deviation 1.76
|
1.08 score on a scale
Standard Deviation 1.75
|
|
Subjective Units of Distress (SUDS)
Recall Post-Visit 4
|
1.56 score on a scale
Standard Deviation 1.81
|
1.70 score on a scale
Standard Deviation 2.21
|
1.25 score on a scale
Standard Deviation 2.26
|
1.21 score on a scale
Standard Deviation 1.53
|
1.38 score on a scale
Standard Deviation 1.76
|
1.77 score on a scale
Standard Deviation 1.76
|
|
Subjective Units of Distress (SUDS)
Renewal Pre-Visit 4
|
1.56 score on a scale
Standard Deviation 1.13
|
2.10 score on a scale
Standard Deviation 2.23
|
1.25 score on a scale
Standard Deviation 2.01
|
0.93 score on a scale
Standard Deviation 1.00
|
1.46 score on a scale
Standard Deviation 1.56
|
1.54 score on a scale
Standard Deviation 2.18
|
|
Subjective Units of Distress (SUDS)
Renewal Mid-Visit 4
|
1.67 score on a scale
Standard Deviation 1.12
|
1.80 score on a scale
Standard Deviation 2.30
|
1.25 score on a scale
Standard Deviation 1.76
|
1.29 score on a scale
Standard Deviation 1.68
|
1.54 score on a scale
Standard Deviation 1.51
|
1.46 score on a scale
Standard Deviation 2.03
|
|
Subjective Units of Distress (SUDS)
Renewal Post-Visit 4
|
1.89 score on a scale
Standard Deviation 1.54
|
2.00 score on a scale
Standard Deviation 3.02
|
1.17 score on a scale
Standard Deviation 1.70
|
1.50 score on a scale
Standard Deviation 2.14
|
1.38 score on a scale
Standard Deviation 1.33
|
1.62 score on a scale
Standard Deviation 2.02
|
Adverse Events
PTSD-dronabinol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTSD-placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TEC-dronabinol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TEC-placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HC-dronabinol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HC-placebo
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