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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

263 participants

Primary outcome timeframe

3 hours

Results posted on

2025-12-09

Participant Flow

Participant milestones

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

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

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 hours

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.

Outcome measures

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 dronabinol

Population: 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/placebo

Population: 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

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/placebo

Population: 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

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 drug

Cognitive 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

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 drug

Population: 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

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 drug

Population: 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

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 drug

Cognitive 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

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

Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths

Dronabinol and placebo cigarette SCZ-CUD

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo cigarette and placebo capsule. SCZ-CUD

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

SCZ-CUD not randomized

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Marijuana cigarette and placebo capsule CUD only

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Dronabinol and placebo cigarette CUD only

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Placebo cigarette and placebo capsule CUD only

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Cannabis Use Disorder - CUD Did not randomize

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

SCZ only

Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths

SCZ only - Did not complete Scan 2

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Healthy Control -

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Healthy Control - Did not complete Scan 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Mary F. Brunette

Dartmouth Hitchcock

Phone: 603-646-7019

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place