Trial Outcomes & Findings for Cannabidiol Treatment in Patients With Early Psychosis (NCT NCT02504151)
NCT ID: NCT02504151
Last Updated: 2022-09-06
Results Overview
The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)
Results posted on
2022-09-06
Participant Flow
Participant milestones
| Measure |
Cannabidiol, Then Placebo
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
8
|
10
|
|
First Intervention (4 Weeks)
COMPLETED
|
7
|
9
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Washout (2 Weeks)
STARTED
|
7
|
9
|
|
Washout (2 Weeks)
COMPLETED
|
6
|
9
|
|
Washout (2 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
6
|
9
|
|
Second Intervention (4 Weeks)
COMPLETED
|
4
|
7
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cannabidiol, Then Placebo
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
First Intervention (4 Weeks)
Physician Decision
|
1
|
1
|
|
Washout (2 Weeks)
Lost to Follow-up
|
1
|
0
|
|
Second Intervention (4 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention (4 Weeks)
Physician Decision
|
2
|
1
|
Baseline Characteristics
Cannabidiol Treatment in Patients With Early Psychosis
Baseline characteristics by cohort
| Measure |
Cannabidiol, Then Placebo
n=8 Participants
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 Participants
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.875 years
n=5 Participants
|
26.1 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)Population: The number analyzed in one or more rows differ from the overall number analyzed to reflect the number of participants who completed the scale during each time point.
The Positive and Negative Syndrome Scale is a 30-item scale to assess both the positive and negative symptom symptoms of schizophrenia. The range total score is 30-210. An improvement in symptoms is reflected by a lower score.
Outcome measures
| Measure |
Cannabidiol, Then Placebo
n=8 Participants
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 Participants
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Baseline period 1
|
81.3 score on a scale
Standard Error 2.8
|
84.0 score on a scale
Standard Error 2.3
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 1 period 1
|
78.3 score on a scale
Standard Error 2.8
|
75.3 score on a scale
Standard Error 2.3
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 2 period 1
|
81.4 score on a scale
Standard Error 2.8
|
73.9 score on a scale
Standard Error 2.3
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 3 period 1
|
79.6 score on a scale
Standard Error 2.8
|
70.6 score on a scale
Standard Error 2.4
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 4 period 1
|
72.0 score on a scale
Standard Error 2.8
|
69.0 score on a scale
Standard Error 2.0
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Baseline period 2
|
71.9 score on a scale
Standard Error 3.4
|
68.5 score on a scale
Standard Error 2.4
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 1 period 2
|
75.2 score on a scale
Standard Error 3.4
|
67.6 score on a scale
Standard Error 2.5
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 2 period 2
|
72.7 score on a scale
Standard Error 3.4
|
70.1 score on a scale
Standard Error 2.5
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 3 period 2
|
73.2 score on a scale
Standard Error 3.4
|
69.7 score on a scale
Standard Error 2.6
|
|
Positive and Negative Syndrome Scale (PANSS) Over Time
Week 4 period 2
|
72.4 score on a scale
Standard Error 3.4
|
66.9 score on a scale
Standard Error 2.6
|
PRIMARY outcome
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)Population: The number analyzed in one or more rows differ from the overall number analyzed to reflect the number of participants who completed the scale during each time point.
Clinical Global Impression of Severity Scale score is a global rating of improvement scale, which requires subjects to rate their degree of improvement on a 7-point scale. The total range score is 1-7. A reduction in scores indicates improvement.
Outcome measures
| Measure |
Cannabidiol, Then Placebo
n=8 Participants
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 Participants
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
Clinical Global Impression of Severity Scale Over Time
Week 4 period 2
|
4.3 score on a scale
Standard Deviation 0.2
|
4.2 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Baseline period 1
|
4.1 score on a scale
Standard Deviation 0.2
|
4.2 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 1 period 1
|
4.1 score on a scale
Standard Deviation 0.2
|
4.2 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 2 period 1
|
4.4 score on a scale
Standard Deviation 0.2
|
4.2 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 3 period 1
|
4.4 score on a scale
Standard Deviation 0.2
|
4.4 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 4 period 1
|
4.3 score on a scale
Standard Deviation 0.2
|
4.4 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Baseline period 2
|
4.3 score on a scale
Standard Deviation 0.2
|
4.3 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 1 period 2
|
4.3 score on a scale
Standard Deviation 0.2
|
4.0 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 2 period 2
|
4.3 score on a scale
Standard Deviation 0.2
|
4.4 score on a scale
Standard Deviation 0.2
|
|
Clinical Global Impression of Severity Scale Over Time
Week 3 period 2
|
4.3 score on a scale
Standard Deviation 0.2
|
4.2 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)Population: The number analyzed in one or more rows differ from the overall number analyzed to reflect the number of participants who completed the scale during each time point.
The PAOFI measures subjects' perceptions of functioning when performing everyday tasks and activities that reflect cognitive strengths and weaknesses. Subjects rate each item on a scale ranging from 0 (almost never) to 5 (almost always). The total score is the sum of the responses to each item (score of 0 to 160). High scores on the PAOFI subscales are indicative of poor perceived cognitive functioning. This scale was modified to remove 3 items- so the highest possible score is 145 for this outcome measure.
Outcome measures
| Measure |
Cannabidiol, Then Placebo
n=8 Participants
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 Participants
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 3 period 1
|
93.0 score on a scale
Standard Error 11.3
|
89.9 score on a scale
Standard Error 9.4
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 4 period 1
|
95.6 score on a scale
Standard Error 11.3
|
89.0 score on a scale
Standard Error 9.6
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Baseline period 1
|
90.1 score on a scale
Standard Error 11.3
|
85.1 score on a scale
Standard Error 9.4
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 1 period 1
|
85.3 score on a scale
Standard Error 11.3
|
87.5 score on a scale
Standard Error 9.4
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 2 period 1
|
95.3 score on a scale
Standard Error 11.3
|
74.9 score on a scale
Standard Error 9.4
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Baseline period 2
|
105.4 score on a scale
Standard Error 12.2
|
87.3 score on a scale
Standard Error 9.6
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 1 period 2
|
108.4 score on a scale
Standard Error 12.2
|
88.5 score on a scale
Standard Error 9.7
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 2 period 2
|
104.7 score on a scale
Standard Error 12.2
|
90.7 score on a scale
Standard Error 9.7
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 3 period 2
|
105.2 score on a scale
Standard Error 12.2
|
86.3 score on a scale
Standard Error 9.9
|
|
Patient Assessment of Own Functioning Inventory (PAOFI) Over Time
Week 4 period 2
|
107.2 score on a scale
Standard Error 12.2
|
95.6 score on a scale
Standard Error 9.9
|
SECONDARY outcome
Timeframe: Completed each time subject is seen over 10 weeks (screening, period 1 baseline, period 1 week 1, period 1 week 2, period 1 week 3, period 1 week 4, period 2 baseline, period 2 week 1, period 2 week 2, period 2 week 3, period 2 week 4)Population: The number analyzed in one or more rows differ from the overall number analyzed to reflect the number of participants who completed the scale during each time point.
The Quality of Life Scale (QLS) is a 21-item scale rated from a semi structured interview, each item is rated 0-6. The specific descriptors vary among items, but the high end of the scales (scores of 5 and 6) reflects normal or unimpaired functioning, and the low end of the scales (scores of 0 and 1) reflects severe impairment of the function in question. A highest score of 126 would indicate unimpaired functioning.
Outcome measures
| Measure |
Cannabidiol, Then Placebo
n=8 Participants
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 Participants
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
Quality of Life Scale (QLS) Over Time
Baseline period 1
|
70.4 score on a scale
Standard Error 7.7
|
72.9 score on a scale
Standard Error 6.4
|
|
Quality of Life Scale (QLS) Over Time
Week 1 period 1
|
73.4 score on a scale
Standard Error 7.7
|
74.9 score on a scale
Standard Error 6.4
|
|
Quality of Life Scale (QLS) Over Time
Week 2 period 1
|
69.9 score on a scale
Standard Error 7.7
|
67.1 score on a scale
Standard Error 6.4
|
|
Quality of Life Scale (QLS) Over Time
Week 3 period 1
|
69.0 score on a scale
Standard Error 7.7
|
71.1 score on a scale
Standard Error 6.4
|
|
Quality of Life Scale (QLS) Over Time
Week 4 period 1
|
72.3 score on a scale
Standard Error 7.7
|
70.7 score on a scale
Standard Error 6.5
|
|
Quality of Life Scale (QLS) Over Time
Baseline period 2
|
68.6 score on a scale
Standard Error 8.6
|
73.3 score on a scale
Standard Error 6.5
|
|
Quality of Life Scale (QLS) Over Time
Week 1 period 2
|
68.6 score on a scale
Standard Error 8.6
|
76.7 score on a scale
Standard Error 6.7
|
|
Quality of Life Scale (QLS) Over Time
Week 2 period 2
|
70.1 score on a scale
Standard Error 8.6
|
77.6 score on a scale
Standard Error 6.7
|
|
Quality of Life Scale (QLS) Over Time
Week 3 period 2
|
66.3 score on a scale
Standard Error 8.6
|
78.1 score on a scale
Standard Error 6.8
|
|
Quality of Life Scale (QLS) Over Time
Week 4 period 2
|
71.8 score on a scale
Standard Error 8.6
|
82.7 score on a scale
Standard Error 6.8
|
Adverse Events
Cannabidiol, Then Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo, Then Cannabidiol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cannabidiol, Then Placebo
n=8 participants at risk
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 participants at risk
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
25.0%
2/8 • Number of events 2 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
Other adverse events
| Measure |
Cannabidiol, Then Placebo
n=8 participants at risk
The subject will receive treatment with Cannabidiol (CBD) (800 mg/day) for four weeks, followed by a two week washout period, followed by four weeks of placebo.
Period 1: CBD, 800 mg/day Period 2: Placebo
|
Placebo, Then Cannabidiol
n=10 participants at risk
The subject will receive placebo for four weeks, followed by a 2 week washout period, followed by four weeks of treatment with Cannabidiol (CBD) (800 mg/day).
Period 1: Placebo Period 2: CBD, 800 mg/day
|
|---|---|---|
|
General disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
20.0%
2/10 • Number of events 2 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Psychiatric disorders
Depressed mood, racing thoughts
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 2 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Reproductive system and breast disorders
ER Visit
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Tension headache
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Migraine
|
12.5%
1/8 • Number of events 2 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Sedation
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Scratchy throat and cold symptoms
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Eye disorders
Stye in left eye
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Musculoskeletal and connective tissue disorders
Right shin pain
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Skin and subcutaneous tissue disorders
Increased itchiness of rash
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Increased tiredness
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Musculoskeletal and connective tissue disorders
Pain in right forearm
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Veisalgia
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Blood and lymphatic system disorders
High blood pressure/hospitalization
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Insomnia
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Relapse to PCP, LSD, and opiate use
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Skin and subcutaneous tissue disorders
Rash around tattoo
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Sleeplessness
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Musculoskeletal and connective tissue disorders
Pulled leg muscle
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Skin and subcutaneous tissue disorders
Tingling and numbness on right side to body and face
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Musculoskeletal and connective tissue disorders
Swollen left foot
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
Psychiatric disorders
Worsening of symptoms and more negative affect
|
0.00%
0/8 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
10.0%
1/10 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Flu
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
|
General disorders
Sinusitis
|
12.5%
1/8 • Number of events 1 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
0.00%
0/10 • Adverse Events (AE) were reported at each visit through the duration of the study at 8 weeks.
AEs were collected by randomization arm, not by intervention method (order in the crossover).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place