Trial Outcomes & Findings for Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment? (NCT NCT01964404)
NCT ID: NCT01964404
Last Updated: 2025-12-09
Results Overview
Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.
COMPLETED
PHASE1
263 participants
3 hours
2025-12-09
Participant Flow
Participant milestones
| Measure |
Cannabis Use Disorder
Participants met criteria for Cannabis Use Disorder (CUD)
|
Dual Diagnosis (Schizophrenia and Cannabis Use Disorder)
Participants with a Dual Diagnosis of Schizophrenia and Cannabis Use Disorder
|
Schizophrenia
Participants diagnosed with Schizophrenia
|
Healthy Controls
Participants with no mental health diagnosis or cannabis use
|
Marijuana Cigarette and Placebo Capsule CUD Only
Participants with Cannabis Use Disorder (CUD) and randomized to receive Marijuana Cigarette and Placebo Capsule
|
Dronabinol and Placebo Cigarette CUD Only
Participants met criteria for Cannabis Use Disorder (CUD) and were randomized to Dronabinol and Placebo Cigarette
|
Placebo Cigarette and Placebo Capsule CUD Only
Participants with a diagnosis of Cannabis Use Disorder (CUD) randomized to Placebo Dronabinol and Placebo Cigarette
|
Marijuana Cigarette and Placebo Capsule - SCZ-CUD
Participants with Dual Diagnosis of Schizophrenia and Cannabis Use Disorder (SCZ-CUD) and randomized to Marijuana Cigarette and Placebo Capsule - SCZ-CUD
|
Dronabinol and Placebo Cigarette - SCZ-CUD
Participants diagnosed with Diagnosis Schizophrenia and Cannabis Use Disorder and randomized to Dronabinol and Placebo Cigarette
|
Placebo Cigarette and Placebo Capsule - SCZ-CUD
Participants diagnosed with Schizophrenia and Cannabis Use Disorder and randomized to placebo Cigarette and Placebo Capsule
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Randomization - Scan 1
STARTED
|
111
|
79
|
33
|
40
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Randomization - Scan 1
Enrolled and Completed Neuropsych Testing
|
62
|
43
|
21
|
31
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Randomization - Scan 1
Completed Scan 1
|
54
|
35
|
18
|
28
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Randomization - Scan 1
COMPLETED
|
51
|
34
|
18
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Randomization - Scan 1
NOT COMPLETED
|
60
|
45
|
15
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Randomization - Scan 2
STARTED
|
0
|
0
|
18
|
27
|
17
|
17
|
17
|
11
|
12
|
11
|
|
Randomization - Scan 2
COMPLETED
|
0
|
0
|
18
|
27
|
17
|
17
|
17
|
11
|
12
|
11
|
|
Randomization - Scan 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cannabis Use Disorder
Participants met criteria for Cannabis Use Disorder (CUD)
|
Dual Diagnosis (Schizophrenia and Cannabis Use Disorder)
Participants with a Dual Diagnosis of Schizophrenia and Cannabis Use Disorder
|
Schizophrenia
Participants diagnosed with Schizophrenia
|
Healthy Controls
Participants with no mental health diagnosis or cannabis use
|
Marijuana Cigarette and Placebo Capsule CUD Only
Participants with Cannabis Use Disorder (CUD) and randomized to receive Marijuana Cigarette and Placebo Capsule
|
Dronabinol and Placebo Cigarette CUD Only
Participants met criteria for Cannabis Use Disorder (CUD) and were randomized to Dronabinol and Placebo Cigarette
|
Placebo Cigarette and Placebo Capsule CUD Only
Participants with a diagnosis of Cannabis Use Disorder (CUD) randomized to Placebo Dronabinol and Placebo Cigarette
|
Marijuana Cigarette and Placebo Capsule - SCZ-CUD
Participants with Dual Diagnosis of Schizophrenia and Cannabis Use Disorder (SCZ-CUD) and randomized to Marijuana Cigarette and Placebo Capsule - SCZ-CUD
|
Dronabinol and Placebo Cigarette - SCZ-CUD
Participants diagnosed with Diagnosis Schizophrenia and Cannabis Use Disorder and randomized to Dronabinol and Placebo Cigarette
|
Placebo Cigarette and Placebo Capsule - SCZ-CUD
Participants diagnosed with Schizophrenia and Cannabis Use Disorder and randomized to placebo Cigarette and Placebo Capsule
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Randomization - Scan 1
Screen Fail
|
49
|
36
|
12
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pre-Randomization - Scan 1
Withdrawal by Subject
|
3
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Measure only collected for subjects with SCZ and SCZ-CUD
Baseline characteristics by cohort
| Measure |
Marijuana Cigarette and Placebo Capsule SCZ-CUD
n=11 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and Placebo Cigarette SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo Cigarette and Placebo Capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ-CUD Not Randomized
n=8 Participants
Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized
|
Marijuana Cigarette and Placebo Capsule CUD Only
n=17 Participants
CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant
|
Dronabinol and Placebo Cigarette CUD Only
n=17 Participants
CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
|
Placebo Cigarette and Placebo Capsule CUD Only
n=17 Participants
CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
|
Cannabis Use Disorder - CUD Did Not Randomize
n=10 Participants
Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized
|
SCZ Only
n=18 Participants
No drug intervention - Completed Scan 1 and 2
|
SCZ Only - Did Not Complete Scan 2
n=3 Participants
No drug intervention - Completed Scan 1 but not Scan 2
|
Healthy Control -
n=27 Participants
No drug intervention - Completed Scan 1 and 2
|
Healthy Control - Did Not Complete Scan 2
n=4 Participants
No drug intervention - Completed Scan 1 but not Scan 2
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.00 Years
n=11 Participants
|
28.42 Years
n=12 Participants
|
31.55 Years
n=11 Participants
|
26.75 Years
n=8 Participants
|
43.59 Years
n=17 Participants
|
34.29 Years
n=17 Participants
|
31.53 Years
n=17 Participants
|
34.10 Years
n=10 Participants
|
35.55 Years
n=18 Participants
|
29.66 Years
n=3 Participants
|
33.48 Years
n=27 Participants
|
26.5 Years
n=4 Participants
|
32.59 Years
n=155 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=18 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=27 Participants
|
2 Participants
n=4 Participants
|
35 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
9 Participants
n=12 Participants
|
10 Participants
n=11 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=17 Participants
|
15 Participants
n=17 Participants
|
15 Participants
n=17 Participants
|
9 Participants
n=10 Participants
|
11 Participants
n=18 Participants
|
2 Participants
n=3 Participants
|
19 Participants
n=27 Participants
|
2 Participants
n=4 Participants
|
120 Participants
n=155 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=155 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
11 Participants
n=12 Participants
|
10 Participants
n=11 Participants
|
8 Participants
n=8 Participants
|
17 Participants
n=17 Participants
|
16 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
10 Participants
n=10 Participants
|
18 Participants
n=18 Participants
|
3 Participants
n=3 Participants
|
27 Participants
n=27 Participants
|
4 Participants
n=4 Participants
|
152 Participants
n=155 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=155 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=155 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=11 Participants
|
10 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=17 Participants
|
15 Participants
n=17 Participants
|
15 Participants
n=17 Participants
|
7 Participants
n=10 Participants
|
17 Participants
n=18 Participants
|
3 Participants
n=3 Participants
|
23 Participants
n=27 Participants
|
3 Participants
n=4 Participants
|
135 Participants
n=155 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=155 Participants
|
|
Education, years
|
12.45 Years
STANDARD_DEVIATION 1.695 • n=11 Participants
|
13.92 Years
STANDARD_DEVIATION 1.782 • n=12 Participants
|
13.82 Years
STANDARD_DEVIATION 1.722 • n=11 Participants
|
12.75 Years
STANDARD_DEVIATION 1.165 • n=8 Participants
|
14.12 Years
STANDARD_DEVIATION 1.764 • n=17 Participants
|
14.35 Years
STANDARD_DEVIATION 2.548 • n=17 Participants
|
14.35 Years
STANDARD_DEVIATION 1.967 • n=17 Participants
|
12.8 Years
STANDARD_DEVIATION 1.033 • n=10 Participants
|
13.33 Years
STANDARD_DEVIATION 1.847 • n=18 Participants
|
12 Years
STANDARD_DEVIATION 1 • n=3 Participants
|
17.19 Years
STANDARD_DEVIATION 1.777 • n=27 Participants
|
14.67 Years
STANDARD_DEVIATION 1.155 • n=4 Participants
|
14.28 Years
STANDARD_DEVIATION 2.304 • n=155 Participants
|
|
Schizophrenia, schizoaffective diagnosis
Schizophrenia disorder
|
3 participants
n=11 Participants
|
4 participants
n=12 Participants
|
4 participants
n=11 Participants
|
6 participants
n=8 Participants
|
0 participants
n=17 Participants
|
0 participants
n=17 Participants
|
0 participants
n=17 Participants
|
0 participants
n=10 Participants
|
9 participants
n=18 Participants
|
1 participants
n=3 Participants
|
0 participants
n=27 Participants
|
0 participants
n=4 Participants
|
27 participants
n=155 Participants
|
|
Schizophrenia, schizoaffective diagnosis
Schizoaffective disorder
|
8 participants
n=11 Participants
|
8 participants
n=12 Participants
|
7 participants
n=11 Participants
|
2 participants
n=8 Participants
|
0 participants
n=17 Participants
|
0 participants
n=17 Participants
|
0 participants
n=17 Participants
|
0 participants
n=10 Participants
|
9 participants
n=18 Participants
|
2 participants
n=3 Participants
|
0 participants
n=27 Participants
|
0 participants
n=4 Participants
|
36 participants
n=155 Participants
|
|
PANSS
Positive
|
12.09 units on a scale
STANDARD_DEVIATION 3.91 • n=11 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
12.83 units on a scale
STANDARD_DEVIATION 3.74 • n=12 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
12.82 units on a scale
STANDARD_DEVIATION 3.34 • n=11 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
15.88 units on a scale
STANDARD_DEVIATION 4.88 • n=8 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
—
|
—
|
—
|
—
|
13.11 units on a scale
STANDARD_DEVIATION 3.31 • n=18 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
15.0 units on a scale
STANDARD_DEVIATION 2.65 • n=3 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
—
|
—
|
13.01 units on a scale
STANDARD_DEVIATION 3.73 • n=63 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
|
PANSS
Negative
|
15.82 units on a scale
STANDARD_DEVIATION 8.34 • n=11 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
12.0 units on a scale
STANDARD_DEVIATION 4.41 • n=12 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
15.09 units on a scale
STANDARD_DEVIATION 7.91 • n=11 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
13.63 units on a scale
STANDARD_DEVIATION 3.54 • n=8 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
—
|
—
|
—
|
—
|
14.61 units on a scale
STANDARD_DEVIATION 3.96 • n=18 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
17.66 units on a scale
STANDARD_DEVIATION 6.81 • n=3 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
—
|
—
|
14.19 units on a scale
STANDARD_DEVIATION 5.6 • n=63 Participants • Measure only collected for subjects with SCZ and SCZ-CUD
|
|
Days of Cannabis Use in Past 35
|
10.73 Days
STANDARD_DEVIATION 9.30 • n=11 Participants
|
16.92 Days
STANDARD_DEVIATION 10.10 • n=12 Participants
|
16.64 Days
STANDARD_DEVIATION 10.96 • n=11 Participants
|
18.25 Days
STANDARD_DEVIATION 14.76 • n=8 Participants
|
29.76 Days
STANDARD_DEVIATION 10.14 • n=17 Participants
|
25.18 Days
STANDARD_DEVIATION 12.86 • n=17 Participants
|
24.24 Days
STANDARD_DEVIATION 11.55 • n=17 Participants
|
28.2 Days
STANDARD_DEVIATION 10.35 • n=10 Participants
|
0 Days
STANDARD_DEVIATION 0 • n=18 Participants
|
0 Days
STANDARD_DEVIATION 0 • n=3 Participants
|
0.037 Days
STANDARD_DEVIATION 0.192 • n=27 Participants
|
0.5 Days
STANDARD_DEVIATION 1 • n=4 Participants
|
14.85 Days
STANDARD_DEVIATION 15.54 • n=155 Participants
|
|
Number of Joints Smoked in Past 35 days
|
18.41 Number of Joints
STANDARD_DEVIATION 26.99 • n=11 Participants
|
22.19 Number of Joints
STANDARD_DEVIATION 18.82 • n=12 Participants
|
19.70 Number of Joints
STANDARD_DEVIATION 16.01 • n=11 Participants
|
44.09 Number of Joints
STANDARD_DEVIATION 62.20 • n=8 Participants
|
39.4 Number of Joints
STANDARD_DEVIATION 45.3 • n=17 Participants
|
52.2 Number of Joints
STANDARD_DEVIATION 78.6 • n=17 Participants
|
52.2 Number of Joints
STANDARD_DEVIATION 57.5 • n=17 Participants
|
44.8 Number of Joints
STANDARD_DEVIATION 51.2 • n=10 Participants
|
0 Number of Joints
STANDARD_DEVIATION 0 • n=18 Participants
|
0 Number of Joints
STANDARD_DEVIATION 0 • n=3 Participants
|
0.0357 Number of Joints
STANDARD_DEVIATION 0.188 • n=27 Participants
|
0.333 Number of Joints
STANDARD_DEVIATION 0.577 • n=4 Participants
|
26.01 Number of Joints
STANDARD_DEVIATION 43.45 • n=155 Participants
|
PRIMARY outcome
Timeframe: 3 hoursActivation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=11 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
n=18 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
n=17 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
n=17 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
n=17 Participants
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
n=27 Participants
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
Brain Reward Circuit Activation on fMRI Scan
|
0.05 z-score
Standard Deviation 0.098
|
0.14 z-score
Standard Deviation 0.076
|
0.18 z-score
Standard Deviation 0.127
|
0.12 z-score
Standard Deviation 0.058
|
0.10 z-score
Standard Deviation 0.087
|
0.11 z-score
Standard Deviation 0.081
|
0.17 z-score
Standard Deviation 0.094
|
0.17 z-score
Standard Deviation 0.121
|
PRIMARY outcome
Timeframe: 1 hour after smoking study drug, 3 hours after oral dronabinolPopulation: Data was collected but cannot be compiled and analysis could not be completed due to death of PI and resulting limited resources for scan data compilation and analyses. There are no immediate resources for analysis in the future.
Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 hours after oral THC/placeboPopulation: Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol
Positive and Negative Symptom Scale (PANSS) Positive Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The outcome measure was recorded at single time of measurement. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=11 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
n=18 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
PANSS Positive Symptoms
|
11.0 score on a scale
Standard Error 0.54
|
9.3 score on a scale
Standard Error 0.40
|
10.2 score on a scale
Standard Error 0.56
|
10.6 score on a scale
Standard Error 0.37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 hours after oral THC/placeboPopulation: This analysis tested whether the marijuana cigarette group had different PANSS negative symptom scores compared to the placebo group adjusting for the SCZ only group. (The dronabinol group was tested separately per our analytic plan.). Only participants with Schizophrenia were assessed using the Positive and Negative Symptom Scale, as specified in the Study Protocol.
Positive and Negative Symptom Scale Negative Symptom Mean Subscale Score at 2nd Assessment Day, range 7-49, higher = more symptoms. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=9 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
n=18 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
PANSS Negative Symptoms
|
17.1 score on a scale
Standard Error 0.76
|
16.4 score on a scale
Standard Error 0.67
|
15.8 score on a scale
Standard Error 0.81
|
15.2 score on a scale
Standard Error 0.56
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hours after oral drugCognitive functioning, verbal learning Hopkins Verbal Learning Test (HVLT-R) total raw score. Possible range of scores is 0-35, higher is better functioning. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=9 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
n=17 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
n=16 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
n=16 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
n=18 Participants
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
n=27 Participants
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
Cognitive Functioning, Verbal Learning
|
23.2 score on a scale
Standard Deviation 6.8
|
21.8 score on a scale
Standard Deviation 6.7
|
25.0 score on a scale
Standard Deviation 5.0
|
25.0 score on a scale
Standard Deviation 4.97
|
25.3 score on a scale
Standard Deviation 6.1
|
27.9 score on a scale
Standard Deviation 4.5
|
25.5 score on a scale
Standard Deviation 8.6
|
31.0 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 3 hours after taking oral drugPopulation: Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol
Drug experience ratings of mood and desirability, anxiety rating on a scale of 0-100, higher means more anxiety. The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=10 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
n=18 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
Drug Experience, Anxiety
|
10.03 units on a scale
Standard Deviation 4.64
|
3.88 units on a scale
Standard Deviation 2.06
|
3.96 units on a scale
Standard Deviation 2.30
|
14.31 units on a scale
Standard Deviation 4.72
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 hours after taking oral drugPopulation: Only participants with Schizophrenia and CUD who were given study drug were analyzed for drug experiences, as specified in the Study Protocol
Drug experience ratings of liking rating on a scale of 0-100, higher number = more liking The time frame includes 3 hours after oral THC/placebo and 1 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=10 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
Drug Experience Ratings of Drug Liking
|
56.5 units on a scale
Standard Error 21.66
|
56.36 units on a scale
Standard Error 20.10
|
5.54 units on a scale
Standard Error 3.49
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 hours after oral drugCognitive function, CPT-IP 2 digit measure of Attention. The Continuous Performance Test-Identical Pairs version (CPT-IP)80 assessed attention with range of 1-5, hirer scores indicating better function The outcome measure was recorded at single time of measurement. The time frame includes 4 hours after oral THC/placebo and 2 hour after smoked THC/placebo (the three-hour window is inclusive of the one-hour post smoke). Each individual smoked THC or placebo AND took oral THC or placebo.
Outcome measures
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=11 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette. SCZ-CUD
n=12 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
Marijuana cigarette and placebo capsule CUD only
n=17 Participants
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette CUD only
n=17 Participants
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. CUD only
n=17 Participants
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ only
n=18 Participants
This group of subjects did not have CUD and received no intervention
|
Healthy Controls
n=27 Participants
This group of healthy subjects had no illness and received no intervention
|
|---|---|---|---|---|---|---|---|---|
|
Cognitive Function, CPT-IP 2 Digit
|
3.5 score on a scale
Standard Deviation 0.7
|
3.3 score on a scale
Standard Deviation 0.9
|
3.7 score on a scale
Standard Deviation 0.7
|
4.1 score on a scale
Standard Deviation 0.4
|
3.8 score on a scale
Standard Deviation 0.5
|
3.9 score on a scale
Standard Deviation 0.4
|
3.2 score on a scale
Standard Deviation 1.0
|
4.0 score on a scale
Standard Deviation 0.3
|
Adverse Events
Marijuana cigarette and placebo capsule SCZ-CUD
Dronabinol and placebo cigarette SCZ-CUD
Placebo cigarette and placebo capsule. SCZ-CUD
SCZ-CUD not randomized
Marijuana cigarette and placebo capsule CUD only
Dronabinol and placebo cigarette CUD only
Placebo cigarette and placebo capsule CUD only
Cannabis Use Disorder - CUD Did not randomize
SCZ only
SCZ only - Did not complete Scan 2
Healthy Control -
Healthy Control - Did not complete Scan 2
Serious adverse events
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=11 participants at risk
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette SCZ-CUD
n=12 participants at risk
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 participants at risk
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ-CUD not randomized
n=8 participants at risk
Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized
|
Marijuana cigarette and placebo capsule CUD only
n=17 participants at risk
CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant
|
Dronabinol and placebo cigarette CUD only
n=17 participants at risk
CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
|
Placebo cigarette and placebo capsule CUD only
n=17 participants at risk
CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
|
Cannabis Use Disorder - CUD Did not randomize
n=10 participants at risk
Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized
|
SCZ only
n=18 participants at risk
No drug intervention - Completed Scan 1 and 2
|
SCZ only - Did not complete Scan 2
n=3 participants at risk
No drug intervention - Completed Scan 1 but not Scan 2
|
Healthy Control -
n=27 participants at risk
No drug intervention - Completed Scan 1 and 2
|
Healthy Control - Did not complete Scan 2
n=4 participants at risk
No drug intervention - Completed Scan 1 but not Scan 2
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Psychosis
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
12.5%
1/8 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Psychiatric disorders
Vyvanse Intoxication
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
Other adverse events
| Measure |
Marijuana cigarette and placebo capsule SCZ-CUD
n=11 participants at risk
3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant with THC
|
Dronabinol and placebo cigarette SCZ-CUD
n=12 participants at risk
Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Dronabinol: Capsule with THC
|
Placebo cigarette and placebo capsule. SCZ-CUD
n=11 participants at risk
Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Placebo: Capsule with no active ingredient
|
SCZ-CUD not randomized
n=8 participants at risk
Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized
|
Marijuana cigarette and placebo capsule CUD only
n=17 participants at risk
CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Marijuana: Smoked plant
|
Dronabinol and placebo cigarette CUD only
n=17 participants at risk
CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
|
Placebo cigarette and placebo capsule CUD only
n=17 participants at risk
CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
|
Cannabis Use Disorder - CUD Did not randomize
n=10 participants at risk
Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized
|
SCZ only
n=18 participants at risk
No drug intervention - Completed Scan 1 and 2
|
SCZ only - Did not complete Scan 2
n=3 participants at risk
No drug intervention - Completed Scan 1 but not Scan 2
|
Healthy Control -
n=27 participants at risk
No drug intervention - Completed Scan 1 and 2
|
Healthy Control - Did not complete Scan 2
n=4 participants at risk
No drug intervention - Completed Scan 1 but not Scan 2
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Increased cannabis withdrawal symptoms
|
27.3%
3/11 • Number of events 6 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Psychiatric disorders
Psychiatric symptoms
|
18.2%
2/11 • Number of events 3 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
27.3%
3/11 • Number of events 3 • Since past assessment (1-2 weeks)
|
12.5%
1/8 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Cardiac disorders
Tachycardia
|
18.2%
2/11 • Number of events 2 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
35.3%
6/17 • Number of events 6 • Since past assessment (1-2 weeks)
|
17.6%
3/17 • Number of events 3 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Cardiac disorders
hypertension
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
3.7%
1/27 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Gastrointestinal disorders
Dental Issues
|
9.1%
1/11 • Number of events 2 • Since past assessment (1-2 weeks)
|
25.0%
3/12 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
3.7%
1/27 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
11.8%
2/17 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Psychiatric disorders
Anxiety in MRI
|
9.1%
1/11 • Number of events 2 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 2 • Since past assessment (1-2 weeks)
|
33.3%
1/3 • Number of events 1 • Since past assessment (1-2 weeks)
|
7.4%
2/27 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back, shoulder or neck pain
|
9.1%
1/11 • Number of events 2 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
11.1%
2/18 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
11.8%
2/17 • Number of events 2 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
16.7%
3/18 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
14.8%
4/27 • Number of events 8 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Nervous system disorders
MRI Finding - Nervous System
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
17.6%
3/17 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
22.2%
4/18 • Number of events 4 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
7.4%
2/27 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Gastrointestinal disorders
Nausea or vomiting
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
9.1%
1/11 • Number of events 1 • Since past assessment (1-2 weeks)
|
12.5%
1/8 • Number of events 2 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
3.7%
1/27 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
16.7%
3/18 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
3.7%
1/27 • Number of events 3 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
27.3%
3/11 • Number of events 4 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
11.8%
2/17 • Number of events 4 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
11.1%
2/18 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
14.8%
4/27 • Number of events 4 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Surgical and medical procedures
Hemorrhoids
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Eye disorders
Chalazia
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Cardiac disorders
Abnormal EKG
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Nervous system disorders
Lightheaded/Dizzy
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
11.8%
2/17 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
11.1%
2/18 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
7.4%
2/27 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Nervous system disorders
Dysesthesia/Parasthesia
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
3.7%
1/27 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
3.7%
1/27 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Cardiac disorders
Hypotension
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Infections and infestations
Skin infection
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Vascular disorders
MRI Findings - Vascular
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
MRI Findings - Respiratory
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/12 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
11.8%
2/17 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
7.4%
2/27 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Vascular disorders
Swelling of vein
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Nervous system disorders
Other
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
12.5%
1/8 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
0.00%
0/18 • Since past assessment (1-2 weeks)
|
0.00%
0/3 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Psychiatric disorders
Hallucinations
|
27.3%
3/11 • Number of events 3 • Since past assessment (1-2 weeks)
|
8.3%
1/12 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/11 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/17 • Since past assessment (1-2 weeks)
|
0.00%
0/10 • Since past assessment (1-2 weeks)
|
11.1%
2/18 • Number of events 2 • Since past assessment (1-2 weeks)
|
33.3%
1/3 • Number of events 1 • Since past assessment (1-2 weeks)
|
0.00%
0/27 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
|
Psychiatric disorders
Anxiety
|
27.3%
3/11 • Number of events 3 • Since past assessment (1-2 weeks)
|
16.7%
2/12 • Number of events 2 • Since past assessment (1-2 weeks)
|
18.2%
2/11 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/8 • Since past assessment (1-2 weeks)
|
23.5%
4/17 • Number of events 4 • Since past assessment (1-2 weeks)
|
11.8%
2/17 • Number of events 3 • Since past assessment (1-2 weeks)
|
5.9%
1/17 • Number of events 1 • Since past assessment (1-2 weeks)
|
10.0%
1/10 • Number of events 1 • Since past assessment (1-2 weeks)
|
5.6%
1/18 • Number of events 1 • Since past assessment (1-2 weeks)
|
33.3%
1/3 • Number of events 1 • Since past assessment (1-2 weeks)
|
7.4%
2/27 • Number of events 2 • Since past assessment (1-2 weeks)
|
0.00%
0/4 • Since past assessment (1-2 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place