Trial Outcomes & Findings for Brain Imaging of Cannabinoid Receptors (NCT NCT03204305)
NCT ID: NCT03204305
Last Updated: 2023-03-21
Results Overview
Distribution Volume (VT) is the quantification of 11C-OMAR binding to the CB1R; Per our statistical plan we examined VT for eight volumes of interest in the brain (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as well as the composite VT for the brain. The unit of measure is mL/cm\^3.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Collected during 90-min PET study
Results posted on
2023-03-21
Participant Flow
15 participants (8 females, 7 males) did not start, but were historical controls included for data analysis
Participant milestones
| Measure |
Female Cannabis Users
Females with cannabis use disorder (CUD): reported using cannabis on average ≥ 25 days per month in the past 3 months, positive test for cannabis on a urine screen, met DSM-V criteria for moderate or severe CUD, and reported ≥ 2 cannabis withdrawal symptoms during a past cannabis abstinence period.
|
Female Healthy Nonuser Controls
Female healthy controls (nonusers): no cannabis use for ≥ 12 months, ≤ 5 lifetime cannabis uses, negative urine test for cannabis
|
Female Non-user Healthy Historical Controls
Female non-users who were not enrolled in the study but were collapsed into the same category as contemporary controls (n = 2) bringing total number of female non-user healthy controls to 10.
|
Male Healthy Historical Controls
Male healthy historical controls (nonusers) who were not enrolled in the study but were used for gender comparison
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
7
|
8
|
7
|
|
Overall Study
COMPLETED
|
10
|
2
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
0
|
0
|
Reasons for withdrawal
| Measure |
Female Cannabis Users
Females with cannabis use disorder (CUD): reported using cannabis on average ≥ 25 days per month in the past 3 months, positive test for cannabis on a urine screen, met DSM-V criteria for moderate or severe CUD, and reported ≥ 2 cannabis withdrawal symptoms during a past cannabis abstinence period.
|
Female Healthy Nonuser Controls
Female healthy controls (nonusers): no cannabis use for ≥ 12 months, ≤ 5 lifetime cannabis uses, negative urine test for cannabis
|
Female Non-user Healthy Historical Controls
Female non-users who were not enrolled in the study but were collapsed into the same category as contemporary controls (n = 2) bringing total number of female non-user healthy controls to 10.
|
Male Healthy Historical Controls
Male healthy historical controls (nonusers) who were not enrolled in the study but were used for gender comparison
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
failure to place arterial line
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Only 10 participants were cannabis users (healthy controls had used cannabis ≤ 5 times in lifetime); therefore, "age of first cannabis use" data was only collected for the group of cannabis users.
Baseline characteristics by cohort
| Measure |
Female Cannabis Users With CUD
n=10 Participants
Smoked Cannabis plant material (0 and 25 mg THC) will be administered to volunteers who are regular cannabis users. Cannabis users will also complete a PET scan where 20 millicurie of 11C-OMAR
11C-OMAR: 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
Cannabis: Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
|
Nonuser Female Healthy Controls (Contemporary and Historical)
n=10 Participants
No cannabis administration. Non-user controls will complete a PET scan where 20 millicuries of 11C-OMAR.
11C-OMAR: 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
Contemporary and historical female non-user healthy controls were collapsed into one group due to low enrollment of contemporary healthy controls.
|
Male Non-user Historical Controls
n=7 Participants
Historical male non-user healthy controls used for comparison
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 2.7 • n=10 Participants
|
25.5 years
STANDARD_DEVIATION 5.0 • n=10 Participants
|
29.6 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 5.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=27 Participants
|
|
Age of first cannabis use
|
15.3 years
STANDARD_DEVIATION 3.0 • n=10 Participants • Only 10 participants were cannabis users (healthy controls had used cannabis ≤ 5 times in lifetime); therefore, "age of first cannabis use" data was only collected for the group of cannabis users.
|
—
|
—
|
15.3 years
STANDARD_DEVIATION 3.0 • n=10 Participants • Only 10 participants were cannabis users (healthy controls had used cannabis ≤ 5 times in lifetime); therefore, "age of first cannabis use" data was only collected for the group of cannabis users.
|
|
Years of cannabis use
|
7.9 years
STANDARD_DEVIATION 4.3 • n=10 Participants • Only 10 participants were cannabis users (healthy controls had used cannabis ≤ 5 times in lifetime); therefore, "years of cannabis use" only applies to the group of cannabis users.
|
—
|
—
|
7.9 years
STANDARD_DEVIATION 4.3 • n=10 Participants • Only 10 participants were cannabis users (healthy controls had used cannabis ≤ 5 times in lifetime); therefore, "years of cannabis use" only applies to the group of cannabis users.
|
PRIMARY outcome
Timeframe: Collected during 90-min PET studyPopulation: Nonuser female healthy controls group includes 2 contemporary female controls and 8 historical female controls.
Distribution Volume (VT) is the quantification of 11C-OMAR binding to the CB1R; Per our statistical plan we examined VT for eight volumes of interest in the brain (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as well as the composite VT for the brain. The unit of measure is mL/cm\^3.
Outcome measures
| Measure |
Cannabis Users
n=10 Participants
Smoked Cannabis plant material (0 and 25 mg THC) will be administered to volunteers who are regular cannabis users. Cannabis users will also complete a PET scan where 20 millicurie of 11C-OMAR
11C-OMAR: 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
Cannabis: Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
|
Nonuser Female Healthy Controls
n=10 Participants
No cannabis administration. Non-user controls will complete a PET scan where 20 millicuries of 11C-OMAR
11C-OMAR: 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
|
Historical Non-user Male Healthy Controls
n=7 Participants
Healthy, non-user historical male controls
|
|---|---|---|---|
|
Distribution Volume (VT)
Amygdala VT
|
1.27 mL/cm^3
Standard Error 0.19
|
1.54 mL/cm^3
Standard Error 0.29
|
1.14 mL/cm^3
Standard Error 0.18
|
|
Distribution Volume (VT)
Cingulate VT
|
1.31 mL/cm^3
Standard Error 0.2
|
1.56 mL/cm^3
Standard Error 0.27
|
1.19 mL/cm^3
Standard Error 0.16
|
|
Distribution Volume (VT)
Frontal lobe VT
|
1.29 mL/cm^3
Standard Error 0.19
|
1.51 mL/cm^3
Standard Error 0.26
|
1.18 mL/cm^3
Standard Error 0.16
|
|
Distribution Volume (VT)
Globus Pall VT
|
1.77 mL/cm^3
Standard Error 0.29
|
1.87 mL/cm^3
Standard Error 0.35
|
1.38 mL/cm^3
Standard Error 0.24
|
|
Distribution Volume (VT)
Hippocampus VT
|
1.28 mL/cm^3
Standard Error 0.20
|
1.54 mL/cm^3
Standard Error 0.29
|
1.19 mL/cm^3
Standard Error 0.19
|
|
Distribution Volume (VT)
Insula VT
|
1.37 mL/cm^3
Standard Error 0.21
|
1.62 mL/cm^3
Standard Error 0.28
|
1.24 mL/cm^3
Standard Error 0.18
|
|
Distribution Volume (VT)
Putamen VT
|
1.52 mL/cm^3
Standard Error 0.21
|
1.69 mL/cm^3
Standard Error 0.29
|
1.31 mL/cm^3
Standard Error 0.19
|
|
Distribution Volume (VT)
Ventral straitum VT
|
1.36 mL/cm^3
Standard Error 0.22
|
1.52 mL/cm^3
Standard Error 0.26
|
1.21 mL/cm^3
Standard Error 0.18
|
|
Distribution Volume (VT)
Composite VT
|
1.27 mL/cm^3
Standard Error 0.19
|
1.45 mL/cm^3
Standard Error 0.24
|
1.15 mL/cm^3
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Up to 5 daysPopulation: Females with CUD who completed cannabis administration sessions 1 and 2
Marijuana withdrawal discomfort will be self-reported using the marijuana withdrawal checklist, available via PhenXToolkit.org. Items are: depressed mood, irritability, nervousness/anxiety, restlessness, increased aggression, increased anger, violent outbursts, nausea, decreased appetite, stomach pain, shakiness, sweating, sleep difficulty, strange/wild dreams, craving to smoke cannabis, diarrhea/loose stools, dizziness, muscle spasms/aches, hiccups, stuffy nose, feverish feeling, hot flashes, chills, increased appetite, headaches, fatigue/tiredness, yawning, difficulty concentrating, general physical discomfort, and other. Each item is rated as 0=none, 1=mild, 2=moderate, or 3=severe. A sum score is calculated from items that are valid, reliable cannabis withdrawal symptoms (Budney et al, 2003, Journal of Abnormal Psychology,112(3): 393-402). A higher score represents more severe withdrawal. Scores range from 0-36.
Outcome measures
| Measure |
Cannabis Users
n=14 Participants
Smoked Cannabis plant material (0 and 25 mg THC) will be administered to volunteers who are regular cannabis users. Cannabis users will also complete a PET scan where 20 millicurie of 11C-OMAR
11C-OMAR: 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
Cannabis: Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
|
Nonuser Female Healthy Controls
No cannabis administration. Non-user controls will complete a PET scan where 20 millicuries of 11C-OMAR
11C-OMAR: 11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
|
Historical Non-user Male Healthy Controls
Healthy, non-user historical male controls
|
|---|---|---|---|
|
Peak Change From Baseline Marijuana Withdrawal Discomfort Score
Marijuana Withdrawal Discomfort Score: Score Pre Cannabis Administration session 2
|
2.30 score on a scale
Standard Deviation 2.26
|
—
|
—
|
|
Peak Change From Baseline Marijuana Withdrawal Discomfort Score
Marijuana Withdrawal Discomfort Score: Peak score during 3 day Inpatient abstinence period
|
4.80 score on a scale
Standard Deviation 3.85
|
—
|
—
|
Adverse Events
Females With Cannabis Use Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nonuser Female Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Female Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Historical Male Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elise M. Weerts, PhD, Professor
Johns Hopkins School of Medicine
Phone: 443-550-2781
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place