Trial Outcomes & Findings for Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study (NCT NCT03008005)
NCT ID: NCT03008005
Last Updated: 2025-08-22
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
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1), for approximately 1.5 hours each day
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Placebo Oral Capsule
Trauma-exposed individuals that received a one-time oral dose of placebo.
|
Dronabinol Cap 5 Milligrams (MG)
Trauma-exposed individuals that received a one-time oral dose of 5mg dronabinol.
|
Dronabinol Cap 10 Milligrams (MG)
Trauma-exposed individuals that received a one-time oral dose of 10mg dronabinol.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
15
|
|
Overall Study
COMPLETED
|
12
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Oral Capsule
Trauma-exposed individuals that received a one-time oral dose of placebo.
|
Dronabinol Cap 5 Milligrams (MG)
Trauma-exposed individuals that received a one-time oral dose of 5mg dronabinol.
|
Dronabinol Cap 10 Milligrams (MG)
Trauma-exposed individuals that received a one-time oral dose of 10mg dronabinol.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Ineligible
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study
Baseline characteristics by cohort
| Measure |
Placebo Oral Capsule
n=14 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of placebo.
|
Dronabinol Cap 5 Milligrams (MG)
n=17 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of 5mg dronabinol.
|
Dronabinol Cap 10 Milligrams (MG)
n=15 Participants
Trauma-exposed individuals with PTSD that received a one-time oral dose of 10mg dronabinol.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 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
|
|
Age, Continuous
|
26.29 years
STANDARD_DEVIATION 10.22 • n=5 Participants
|
25.59 years
STANDARD_DEVIATION 9.81 • n=7 Participants
|
25.13 years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
25.63 years
STANDARD_DEVIATION 8.85 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
15 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
CAPS-5
|
35.71 scores on a scale
STANDARD_DEVIATION 12.29 • n=5 Participants
|
35.65 scores on a scale
STANDARD_DEVIATION 10.25 • n=7 Participants
|
35.60 scores on a scale
STANDARD_DEVIATION 12.27 • n=5 Participants
|
35.66 scores on a scale
STANDARD_DEVIATION 11.30 • n=4 Participants
|
|
PCL-5
|
39.29 scores on a scale
STANDARD_DEVIATION 17.17 • n=5 Participants
|
45.71 scores on a scale
STANDARD_DEVIATION 15.56 • n=7 Participants
|
46.40 scores on a scale
STANDARD_DEVIATION 16.65 • n=5 Participants
|
43.99 scores on a scale
STANDARD_DEVIATION 16.35 • n=4 Participants
|
PRIMARY outcome
Timeframe: Brain measures are collected on Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 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 |
Placebo Oral Capsule
n=11 Participants
In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
Placebo Oral Capsule: Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.
|
Dronabinol Cap 5 Milligrams (MG)
n=11 Participants
In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
Dronabinol Cap 5 milligrams (MG): Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
|
Dronabinol Cap 10 Milligrams (MG)
n=14 Participants
In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
Dronabinol Cap 10 milligrams (MG): Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
|
|---|---|---|---|
|
Brain Measures
Recall CS+E vmPFC-Visit 4
|
-0.092562327 arbitrary units
Standard Deviation 0.12096037
|
-0.046500136 arbitrary units
Standard Deviation 0.148710336
|
-0.042297714 arbitrary units
Standard Deviation 0.131211376
|
|
Brain Measures
Recall CS- Amygdala-Visit 4
|
0.023179891 arbitrary units
Standard Deviation 0.369129301
|
-0.045574364 arbitrary units
Standard Deviation 0.217199197
|
0.084785971 arbitrary units
Standard Deviation 0.188667772
|
|
Brain Measures
Recall CS+U Amygdala-Visit 4
|
0.073318518 arbitrary units
Standard Deviation 0.176984276
|
-0.002491309 arbitrary units
Standard Deviation 0.192822633
|
0.106574214 arbitrary units
Standard Deviation 0.294631794
|
|
Brain Measures
Recall CS+U Hippocampus-Visit 4
|
0.0027553 arbitrary units
Standard Deviation 0.114973037
|
-0.048798436 arbitrary units
Standard Deviation 0.104668268
|
0.039578357 arbitrary units
Standard Deviation 0.157749137
|
|
Brain Measures
Renewal CS+E vmPFC-Visit 4
|
-0.025462455 arbitrary units
Standard Deviation 0.061109422
|
-0.051927636 arbitrary units
Standard Deviation 0.137163274
|
-0.044782714 arbitrary units
Standard Deviation 0.149704378
|
|
Brain Measures
Renewal CS- Amygdala-Visit 4
|
0.038667909 arbitrary units
Standard Deviation 0.313060636
|
0.041082273 arbitrary units
Standard Deviation 0.249335278
|
0.089871571 arbitrary units
Standard Deviation 0.284506548
|
|
Brain Measures
Renewal CS- Hippocampus-Visit 4
|
0.010737545 arbitrary units
Standard Deviation 0.135826418
|
0.028653909 arbitrary units
Standard Deviation 0.108329415
|
0.026597157 arbitrary units
Standard Deviation 0.177134712
|
|
Brain Measures
Renewal CS+E Hippocampus-Visit 5
|
0.063149555 arbitrary units
Standard Deviation 0.194680145
|
0.031223436 arbitrary units
Standard Deviation 0.165435695
|
0.031342243 arbitrary units
Standard Deviation 0.179872674
|
|
Brain Measures
Renewal CS+E vmPFC-Visit 5
|
0.066609182 arbitrary units
Standard Deviation 0.266328372
|
0.040283 arbitrary units
Standard Deviation 0.147068638
|
0.048598129 arbitrary units
Standard Deviation 0.198056416
|
|
Brain Measures
Renewal CS- Amygdala-Visit 5
|
0.183916727 arbitrary units
Standard Deviation 0.306917185
|
0.124069727 arbitrary units
Standard Deviation 0.211486836
|
0.15168205 arbitrary units
Standard Deviation 0.351211445
|
|
Brain Measures
Renewal Hippocampus-Visit 5
|
0.013174 arbitrary units
Standard Deviation 0.209268027
|
0.056026436 arbitrary units
Standard Deviation 0.151187117
|
0.041636779 arbitrary units
Standard Deviation 0.19943295
|
|
Brain Measures
Extinction Learning CS+E Amygdala-Visit 3
|
0.039567327 arbitrary units
Standard Deviation 0.241268856
|
0.092173636 arbitrary units
Standard Deviation 0.327156274
|
0.149446357 arbitrary units
Standard Deviation 0.335179325
|
|
Brain Measures
Extinction Learning CS+E Hippocampus-Visit 3
|
-0.021618 arbitrary units
Standard Deviation 0.186131283
|
0.000147182 arbitrary units
Standard Deviation 0.135589364
|
0.0734664 arbitrary units
Standard Deviation 0.112658087
|
|
Brain Measures
Extinction Learning CS+E vmPFC-Visit 3
|
-0.100398455 arbitrary units
Standard Deviation 0.251500983
|
-0.140956909 arbitrary units
Standard Deviation 0.199637856
|
-0.014101643 arbitrary units
Standard Deviation 0.20111521
|
|
Brain Measures
Extinction Learning CS- Amygdala-Visit 3
|
0.058886909 arbitrary units
Standard Deviation 0.204782961
|
-0.006294273 arbitrary units
Standard Deviation 0.261622699
|
0.160143 arbitrary units
Standard Deviation 0.241651249
|
|
Brain Measures
Extinction Learning CS- Hippocampus-Visit 3
|
-0.059069435 arbitrary units
Standard Deviation 0.127779008
|
-0.133546182 arbitrary units
Standard Deviation 0.107201148
|
-0.022569714 arbitrary units
Standard Deviation 0.101622507
|
|
Brain Measures
Extinction Learning CS- vmPFC-Visit 3
|
-0.108475118 arbitrary units
Standard Deviation 0.164705482
|
-0.144499545 arbitrary units
Standard Deviation 0.207477253
|
-0.058264393 arbitrary units
Standard Deviation 0.166826016
|
|
Brain Measures
Recall CS+E Amygdala-Visit 4
|
0.064068818 arbitrary units
Standard Deviation 0.126060842
|
0.05063 arbitrary units
Standard Deviation 0.246216857
|
0.021313529 arbitrary units
Standard Deviation 0.144489742
|
|
Brain Measures
Recall CS+E Hippocampus-Visit 4
|
-0.018730882 arbitrary units
Standard Deviation 0.105994504
|
-0.009476018 arbitrary units
Standard Deviation 0.079625507
|
-0.008622411 arbitrary units
Standard Deviation 0.061309342
|
|
Brain Measures
Recall CS- Hippocampus-Visit 4
|
0.016318864 arbitrary units
Standard Deviation 0.130857648
|
-0.012782118 arbitrary units
Standard Deviation 0.074290578
|
0.021303429 arbitrary units
Standard Deviation 0.086215257
|
|
Brain Measures
Recall CS- vmPFC-Visit 4
|
-0.025044173 arbitrary units
Standard Deviation 0.087226891
|
-0.111483273 arbitrary units
Standard Deviation 0.136683884
|
-0.023582643 arbitrary units
Standard Deviation 0.092589989
|
|
Brain Measures
Recall CS+U vmPFC-Visit 4
|
-0.063881291 arbitrary units
Standard Deviation 0.195166763
|
-0.11082 arbitrary units
Standard Deviation 0.125147494
|
-0.068200429 arbitrary units
Standard Deviation 0.173367568
|
|
Brain Measures
Renewal CS+E Amygdala-Visit 4
|
-0.007166727 arbitrary units
Standard Deviation 0.16281838
|
0.085493291 arbitrary units
Standard Deviation 0.195124774
|
-0.038971376 arbitrary units
Standard Deviation 0.225437092
|
|
Brain Measures
Renewal CS+E Hippocampus-Visit 4
|
-0.042572273 arbitrary units
Standard Deviation 0.121258736
|
0.053855418 arbitrary units
Standard Deviation 0.10101509
|
0.022821236 arbitrary units
Standard Deviation 0.09697586
|
|
Brain Measures
Renewal CS- vmPFC-Visit 4
|
-0.0115975 arbitrary units
Standard Deviation 0.174869566
|
-0.035996455 arbitrary units
Standard Deviation 0.159479443
|
0.015976671 arbitrary units
Standard Deviation 0.173108329
|
|
Brain Measures
Renewal CS+U Amygdala-Visit 4
|
0.033922182 arbitrary units
Standard Deviation 0.196452024
|
-0.019035273 arbitrary units
Standard Deviation 0.347223043
|
0.04350675 arbitrary units
Standard Deviation 0.228228503
|
|
Brain Measures
Renewal CS+U Hippocampus-Visit 4
|
0.001226509 arbitrary units
Standard Deviation 0.14949891
|
0.040038355 arbitrary units
Standard Deviation 0.128456906
|
0.037054743 arbitrary units
Standard Deviation 0.086797744
|
|
Brain Measures
Renewal CS+U vmPFC-Visit 4
|
-0.024311655 arbitrary units
Standard Deviation 0.109098602
|
-0.063822713 arbitrary units
Standard Deviation 0.149376423
|
-0.028642293 arbitrary units
Standard Deviation 0.086767322
|
|
Brain Measures
Recall CS+E Amygdala-Visit 5
|
0.102081909 arbitrary units
Standard Deviation 0.267334482
|
-0.112056636 arbitrary units
Standard Deviation 0.329023209
|
0.175857929 arbitrary units
Standard Deviation 0.2753103
|
|
Brain Measures
Recall CS+E Hippocampus-Visit 5
|
0.066236364 arbitrary units
Standard Deviation 0.194500373
|
-0.017467364 arbitrary units
Standard Deviation 0.172543206
|
0.127993357 arbitrary units
Standard Deviation 0.130790704
|
|
Brain Measures
Recall CS+E vmPFC-Visit 5
|
0.0327043 arbitrary units
Standard Deviation 0.157330444
|
-0.017208209 arbitrary units
Standard Deviation 0.168514694
|
0.007210571 arbitrary units
Standard Deviation 0.152128778
|
|
Brain Measures
Recall CS- Amygdala-Visit 5
|
0.095167636 arbitrary units
Standard Deviation 0.307824688
|
-0.060291409 arbitrary units
Standard Deviation 0.232370391
|
0.154838214 arbitrary units
Standard Deviation 0.250376068
|
|
Brain Measures
Recall CS- Hippocampus-Visit 5
|
0.007481636 arbitrary units
Standard Deviation 0.231953032
|
0.006147773 arbitrary units
Standard Deviation 0.11636263
|
0.0426459 arbitrary units
Standard Deviation 0.145582746
|
|
Brain Measures
Recall CS- vmPFC-Visit 5
|
0.017899909 arbitrary units
Standard Deviation 0.164153846
|
-0.027662455 arbitrary units
Standard Deviation 0.149608896
|
-0.056348421 arbitrary units
Standard Deviation 0.211452199
|
|
Brain Measures
Recall CS+U Amygdala-Visit 5
|
0.067971218 arbitrary units
Standard Deviation 0.201754089
|
0.052176091 arbitrary units
Standard Deviation 0.407452643
|
0.089821286 arbitrary units
Standard Deviation 0.468006999
|
|
Brain Measures
Recall CS+U Hippocampus-Visit 5
|
0.023053471 arbitrary units
Standard Deviation 0.152490758
|
-0.009212182 arbitrary units
Standard Deviation 0.139630295
|
0.073768357 arbitrary units
Standard Deviation 0.26781902
|
|
Brain Measures
Recall CS+U vmPFC-Visit 5
|
-0.041723673 arbitrary units
Standard Deviation 0.105402346
|
-0.024672805 arbitrary units
Standard Deviation 0.125923794
|
-0.026101643 arbitrary units
Standard Deviation 0.16205021
|
|
Brain Measures
Renewal CS+E Amygdala-Visit 5
|
0.061899727 arbitrary units
Standard Deviation 0.372039765
|
0.076936818 arbitrary units
Standard Deviation 0.234232725
|
0.091302143 arbitrary units
Standard Deviation 0.274868067
|
|
Brain Measures
Renewal CS- vmPFC-Visit 5
|
0.018359999 arbitrary units
Standard Deviation 0.217672587
|
0.0344149 arbitrary units
Standard Deviation 0.167694371
|
-0.048354143 arbitrary units
Standard Deviation 0.323141034
|
|
Brain Measures
Renewal CS+U Amygdala-Visit 5
|
0.312260455 arbitrary units
Standard Deviation 0.25005898
|
0.182693845 arbitrary units
Standard Deviation 0.255384016
|
0.095871914 arbitrary units
Standard Deviation 0.542394387
|
|
Brain Measures
Renewal CS+U Hippocampus-Visit 5
|
0.111670727 arbitrary units
Standard Deviation 0.190179528
|
0.057369273 arbitrary units
Standard Deviation 0.133003425
|
0.009984107 arbitrary units
Standard Deviation 0.265241884
|
|
Brain Measures
Renewal CS+U vmPFC-Visit 5
|
0.056020818 arbitrary units
Standard Deviation 0.195016729
|
0.085382818 arbitrary units
Standard Deviation 0.121708322
|
0.016284214 arbitrary units
Standard Deviation 0.334969996
|
PRIMARY outcome
Timeframe: Collected on Visit 2, 7 days from baseline (Visit 1), Visit 3, 14 days from baseline (Visit 1), Visit 4, 15 days from baseline (Visit 1), and Visit 5, 21 days from baseline (Visit 1) during the task. Each day the task lasts approximately 20 minutes.Population: The number analyzed per row may differ from the overall 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 |
Placebo Oral Capsule
n=11 Participants
In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
Placebo Oral Capsule: Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.
|
Dronabinol Cap 5 Milligrams (MG)
n=11 Participants
In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
Dronabinol Cap 5 milligrams (MG): Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
|
Dronabinol Cap 10 Milligrams (MG)
n=14 Participants
In a randomized, double-blind, placebo-controlled, between-subjects design, we will administer a one-time oral dose of dronabinol (5mg or 10mg) or placebo (PBO) approximately two hours prior to MR scanning and task performance in 78 patients with PTSD.
One-third of the participants will receive 5mg dronabinol (n=26) , one-third of the participants will receive 10mg dronabinol (n=26), and the remaining one-third of the participants will receive placebo (n=26).
Dronabinol Cap 10 milligrams (MG): Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
|
|---|---|---|---|
|
Expectancy Ratings
Renewal CS+U Early-Visit 4 · I Don't Know
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 4 · Yes
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 4 · I Don't Know
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 4 · No
|
9 Participants
|
6 Participants
|
8 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 4 · I Don't Know
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 4 · Yes
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 4 · No
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 4 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 4 · No
|
10 Participants
|
9 Participants
|
11 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 4 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 4 · No
|
11 Participants
|
9 Participants
|
11 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 4 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 5 · No
|
6 Participants
|
9 Participants
|
7 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 5 · I Don't Know
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 5 · No
|
7 Participants
|
9 Participants
|
8 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 5 · I Don't Know
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 5 · Yes
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 5 · No
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 5 · I Don't Know
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 5 · No
|
10 Participants
|
10 Participants
|
10 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 5 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 5 · No
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 5 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Acquisition CS+E Early-Visit 2 · No
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+U Early-Visit 2 · Yes
|
10 Participants
|
8 Participants
|
7 Participants
|
|
Expectancy Ratings
Acquisition CS- Early-Visit 2 · No
|
6 Participants
|
9 Participants
|
5 Participants
|
|
Expectancy Ratings
Acquisition CS- Late-Visit 2 · I Don't Know
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Extinction CS- Early-Visit 3 · No
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Expectancy Ratings
Extinction CS- Early-Visit 3 · I Don't Know
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Expectancy Ratings
Extinction CS- Early-Visit 3 · Yes
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 4 · I Don't Know
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 4 · Yes
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 4 · No
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 4 · I Don't Know
|
4 Participants
|
0 Participants
|
7 Participants
|
|
Expectancy Ratings
Recall CS+U Early-Visit 4 · Yes
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 4 · No
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 4 · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 4 · No
|
10 Participants
|
10 Participants
|
11 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 4 · No
|
11 Participants
|
9 Participants
|
10 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 4 · No
|
3 Participants
|
8 Participants
|
7 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 4 · I Don't Know
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 4 · Yes
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 4 · No
|
5 Participants
|
8 Participants
|
7 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 5 · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS- Early-Visit 5 · Yes
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 5 · No
|
10 Participants
|
9 Participants
|
10 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 5 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 5 · No
|
7 Participants
|
9 Participants
|
7 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 5 · I Don't Know
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Expectancy Ratings
Renewal CS+E Early-Visit 5 · Yes
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 5 · No
|
11 Participants
|
9 Participants
|
8 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 5 · I Don't Know
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Expectancy Ratings
Renewal CS+U Early-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 5 · No
|
9 Participants
|
8 Participants
|
7 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 5 · I Don't Know
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Expectancy Ratings
Renewal CS- Early-Visit 5 · Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 5 · No
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 5 · I Don't Know
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Expectancy Ratings
Renewal CS+E Late-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 5 · No
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 5 · I Don't Know
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Expectancy Ratings
Renewal CS+U Late-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 5 · No
|
11 Participants
|
10 Participants
|
10 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 5 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Renewal CS- Late-Visit 5 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Acquisition CS+E Early-Visit 2 · I Don't Know
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Acquisition CS+E Early-Visit 2 · Yes
|
8 Participants
|
5 Participants
|
8 Participants
|
|
Expectancy Ratings
Acquisition CS+U Early-Visit 2 · No
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Expectancy Ratings
Acquisition CS+U Early-Visit 2 · I Don't Know
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Expectancy Ratings
Acquisition CS- Early-Visit 2 · I Don't Know
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Expectancy Ratings
Acquisition CS- Early-Visit 2 · Yes
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+E Late-Visit 2 · No
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Expectancy Ratings
Acquisition CS+E Late-Visit 2 · I Don't Know
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Acquisition CS+E Late-Visit 2 · Yes
|
6 Participants
|
7 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+U Late-Visit 2 · No
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Expectancy Ratings
Acquisition CS+U Late-Visit 2 · I Don't Know
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Expectancy Ratings
Acquisition CS+U Late-Visit 2 · Yes
|
7 Participants
|
6 Participants
|
8 Participants
|
|
Expectancy Ratings
Acquisition CS- Late-Visit 2 · No
|
11 Participants
|
7 Participants
|
9 Participants
|
|
Expectancy Ratings
Acquisition CS- Late-Visit 2 · Yes
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Expectancy Ratings
Extinction CS+E Early-Visit 3 · No
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Expectancy Ratings
Extinction CS+E Early-Visit 3 · I Don't Know
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Expectancy Ratings
Extinction CS+E Early-Visit 3 · Yes
|
8 Participants
|
5 Participants
|
4 Participants
|
|
Expectancy Ratings
Extinction CS+E Late-Visit 3 · No
|
9 Participants
|
9 Participants
|
9 Participants
|
|
Expectancy Ratings
Extinction CS+E Late-Visit 3 · I Don't Know
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Expectancy Ratings
Extinction CS+E Late-Visit 3 · Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Extinction CS- Late-Visit 3 · No
|
11 Participants
|
9 Participants
|
9 Participants
|
|
Expectancy Ratings
Extinction CS- Late-Visit 3 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Extinction CS- Late-Visit 3 · Yes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Expectancy Ratings
Recall CS+E Early-Visit 4 · No
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 4 · No
|
11 Participants
|
9 Participants
|
11 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 4 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS+E Late-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Expectancy Ratings
Recall CS+U Late-Visit 4 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 4 · I Don't Know
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Expectancy Ratings
Recall CS- Late-Visit 4 · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dronabinol Cap 5 Milligrams (MG)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dronabinol Cap 10 Milligrams (MG)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Oral Capsule
n=13 participants at risk
Trauma-exposed individuals that received a one-time oral dose of placebo.
|
Dronabinol Cap 5 Milligrams (MG)
n=16 participants at risk
Trauma-exposed individuals that received a one-time oral dose of 5mg dronabinol.
|
Dronabinol Cap 10 Milligrams (MG)
n=15 participants at risk
Trauma-exposed individuals that received a one-time oral dose of 10mg dronabinol.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea and Dizziness
|
7.7%
1/13 • Number of events 1 • Adverse events are collected when a participant in enrolled in the study until study completion, which is approximately over a 3 week duration.
|
12.5%
2/16 • Number of events 3 • Adverse events are collected when a participant in enrolled in the study until study completion, which is approximately over a 3 week duration.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected when a participant in enrolled in the study until study completion, which is approximately over a 3 week duration.
|
Additional Information
Dr. Christine Rabinak, Principal Investigator
Wayne State University
Phone: (313) 577-9875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place