Trial Outcomes & Findings for Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD (NCT NCT02759185)
NCT ID: NCT02759185
Last Updated: 2023-07-12
Results Overview
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline (3 weeks after randomization)
Results posted on
2023-07-12
Participant Flow
Participants were recruited via letters of referral sent to psychiatrists and psychotherapists, contact with veterans' organizations, advertisements or announcements placed in appropriate locations or on appropriate internet sites and the sponsor site, and word of mouth.
For Stage 2, participants were re-randomized into one of three treatment groups which excluded placebo and their Stage 1 treatment assignment.
Participant milestones
| Measure |
High THC Cannabis (Stage 1)
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 1)
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 1)
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis (Stage 1)
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
High THC Cannabis (Stage 2)
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 2)
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 2)
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
20
|
20
|
20
|
20
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
19
|
19
|
17
|
20
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
1
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
0
|
29
|
27
|
18
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
27
|
24
|
17
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
High THC Cannabis (Stage 1)
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 1)
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 1)
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis (Stage 1)
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
High THC Cannabis (Stage 2)
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 2)
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 2)
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
|---|---|---|---|---|---|---|---|
|
Stage 1
Adverse Event
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
Baseline characteristics by cohort
| Measure |
High THC Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
High THC/ High CBD Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
High THC/high CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided 1.8 g of cannabis per day a with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD, with smoking limited to no more than 1.8 per day.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 16.6 • n=99 Participants
|
40.4 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
50.6 years
STANDARD_DEVIATION 13.3 • n=206 Participants
|
43.7 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 13.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
72 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Education
High School Graduate
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Education
Some College/Associate's Degree
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Education
College Graduate
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Body mass index (BMI)
|
32.0 kg/m^2
STANDARD_DEVIATION 8.9 • n=99 Participants
|
31.3 kg/m^2
STANDARD_DEVIATION 6.6 • n=107 Participants
|
31.4 kg/m^2
STANDARD_DEVIATION 7.4 • n=206 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 7.0 • n=7 Participants
|
31.9 kg/m^2
STANDARD_DEVIATION 7.4 • n=31 Participants
|
|
Combat-related trauma (yes)
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Sleep Apnea (STOP-bang)
Low risk = 1
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Sleep Apnea (STOP-bang)
Intermediate risk = 2
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sleep Apnea (STOP-bang)
High risk = 3
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
46 Participants
n=31 Participants
|
|
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
|
3.9 score on a scale
STANDARD_DEVIATION 3.0 • n=99 Participants
|
2.5 score on a scale
STANDARD_DEVIATION 2.8 • n=107 Participants
|
2.4 score on a scale
STANDARD_DEVIATION 2.8 • n=206 Participants
|
1.7 score on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
2.6 score on a scale
STANDARD_DEVIATION 2.8 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline (3 weeks after randomization)Population: Intent-to-treat (ITT) set
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
High THC Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Baseline CAPS-5 Total Severity Score
|
36.6 score on a scale
Standard Deviation 7.20
|
36.8 score on a scale
Standard Deviation 8.23
|
38.0 score on a scale
Standard Deviation 7.8
|
37.3 score on a scale
Standard Deviation 6.38
|
PRIMARY outcome
Timeframe: Visit 5 (between end of week 3 and start of week 4) of Stage 1Population: Intent-to-treat (ITT) set
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
High THC Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5)
|
20.5 score on a scale
Standard Deviation 8.97
|
28.1 score on a scale
Standard Deviation 13.26
|
29.6 score on a scale
Standard Deviation 12.17
|
24.2 score on a scale
Standard Deviation 12.79
|
PRIMARY outcome
Timeframe: Baseline (3 weeks after randomization) to Primary Endpoint (Visit 5, between end of week 3 and start of week 4)Population: Intent-to-treat (ITT) set
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
High THC Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5)
|
-15.2 score on a scale
Standard Deviation 11.03
|
-8.4 score on a scale
Standard Deviation 10.09
|
-8.5 score on a scale
Standard Deviation 9.88
|
-13.1 score on a scale
Standard Deviation 12.10
|
SECONDARY outcome
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)Population: Intent-to-treat (ITT) Set
The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to various PTSD symptoms on a five-point Likert-type scale (0=not at all, 4=extremely). The total PCL-5 score (a sum of all 20 items) ranges from 0 to 80, with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
High THC Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=18 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint
|
-23.5 score on a scale
Standard Deviation 16.5
|
-12.1 score on a scale
Standard Deviation 16.2
|
-16.4 score on a scale
Standard Deviation 9.1
|
-14.6 score on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)Population: Intent-to-treat (ITT) set
The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess social anxiety are summed and range from 5 to 25 with higher scores indicating greater anxiety symptoms.
Outcome measures
| Measure |
High THC Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=18 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint
|
-3.7 score on a scale
Standard Deviation 4.2
|
-2.7 score on a scale
Standard Deviation 2.7
|
-2.2 score on a scale
Standard Deviation 2.0
|
-2.4 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)Population: Intent-to-treat (ITT) Set
The Inventory of Psychosocial Functioning (IPF) is an 80-item measure that was developed for use among individuals with PTSD. It assesses current psychosocial functioning across seven domains: romantic relationships, family, work, friendships, parenting, education, and self-care. Items are scored on a 0 (never) to 6 (always) scale. Summation of scores across domains yields a total score for psychosocial functioning, with higher scores indicating greater functional impairment.
Outcome measures
| Measure |
High THC Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=18 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint
|
1.2 score on a scale
Standard Deviation 11.9
|
-1.2 score on a scale
Standard Deviation 5.5
|
4.1 score on a scale
Standard Deviation 8.5
|
-0.2 score on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)Population: Intent-to-treat (ITT) Set
The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess general depression are summed and range from 20 to 100 with higher scores indicating greater depressive symptoms.
Outcome measures
| Measure |
High THC Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=18 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint
|
-16.1 score on a scale
Standard Deviation 12.6
|
-11.4 score on a scale
Standard Deviation 11.7
|
-13.4 score on a scale
Standard Deviation 9.1
|
-8.3 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)Population: Intent-to-treat Set
The Insomnia Severity Index (ISI) is a brief self-reported measure of insomnia. It consists of seven questions, with responses made on a five-point Likert scale. Three items address difficulty at sleep onset, maintaining sleep, and early waking, and four questions address perceived quality of sleep and effects of sleep difficulties on daily function. Questions are summed into a total score that ranges from 0 to 28 and can be interpreted as ranging from no signs of insomnia to severe insomnia. Higher scores indicate more severe insomnia.
Outcome measures
| Measure |
High THC Cannabis
n=18 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=19 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=18 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=20 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint
|
-8.8 score on a scale
Standard Deviation 5.2
|
-5.9 score on a scale
Standard Deviation 6.5
|
-6.6 score on a scale
Standard Deviation 5.2
|
-6.1 score on a scale
Standard Deviation 5.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change in sleep efficiency from baseline to end of 4-week treatment period (visit 6)Population: All participants were asked to wear the Actiwatch for sleep measures and all available data were analyzed to assess sleep efficiency. Note: the proportion of missing data prevented robust analysis and interpretation.
Daily sleep measures were collected using the Actigraph Watch at baseline and throughout the study period. Data were processed using the Actigraph Software according to the User Manual to measure "sleep efficiency," which is defined as the proportion of the estimated sleep periods spent asleep. Change in sleep efficiency was calculated and compared across the four treatment groups to assess whether there was any improvement or worsening in sleep efficiency before and after the 4-week treatment period. Other measures included number of days data were collected and average duration in minutes of time that were excluded and not recorded. Daily data were aggregated to analyze participants' average weekly sleep patterns.
Outcome measures
| Measure |
High THC Cannabis
n=13 Participants
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis
n=12 Participants
Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis
n=10 Participants
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis
n=12 Participants
Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
|---|---|---|---|---|
|
Actigraph Change in Sleep Efficiency
|
0.17 percentage of total sleep time
Standard Deviation 10.9
|
6.83 percentage of total sleep time
Standard Deviation 6.55
|
1.80 percentage of total sleep time
Standard Deviation 8.39
|
-0.28 percentage of total sleep time
Standard Deviation 6.36
|
Adverse Events
High THC Cannabis (Stage 1)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
High CBD Cannabis (Stage 1)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
THC/CBD Cannabis (Stage 1)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo Cannabis (Stage 1)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
High THC Cannabis (Stage 2)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
High CBD Cannabis (Stage 2)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
THC/CBD Cannabis (Stage 2)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High THC Cannabis (Stage 1)
n=20 participants at risk
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 1)
n=20 participants at risk
Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 1)
n=20 participants at risk
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis (Stage 1)
n=20 participants at risk
Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
High THC Cannabis (Stage 2)
n=29 participants at risk
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 2)
n=27 participants at risk
Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 2)
n=18 participants at risk
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Heart palpitations
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Abscess
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
Other adverse events
| Measure |
High THC Cannabis (Stage 1)
n=20 participants at risk
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 1)
n=20 participants at risk
Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 1)
n=20 participants at risk
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.
|
Placebo Cannabis (Stage 1)
n=20 participants at risk
Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol
Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.
|
High THC Cannabis (Stage 2)
n=29 participants at risk
Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol
High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.
|
High CBD Cannabis (Stage 2)
n=27 participants at risk
Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol
High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
THC/CBD Cannabis (Stage 2)
n=18 participants at risk
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol
THC/CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Parosmia
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Anger
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Hostility
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Fungal infections
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Obsessive thoughts
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Suicide ideation
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Eye disorders
Dry eye
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Dry mouth
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
25.0%
5/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
10.3%
3/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Asthenia
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Fatigue
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Feeling abnormal
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Malaise
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Cellulitis
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Ear infection
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Influenza
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
17.2%
5/29 • Baseline to end of study (Approximately 8 months)
|
11.1%
3/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Investigations
Weight decreased
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Investigations
Weight increased
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
16.7%
3/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
20.0%
4/20 • Baseline to end of study (Approximately 8 months)
|
25.0%
5/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Somnolence
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Aggression
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Anxiety
|
25.0%
5/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
20.7%
6/29 • Baseline to end of study (Approximately 8 months)
|
14.8%
4/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Irritability
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
11.1%
3/27 • Baseline to end of study (Approximately 8 months)
|
16.7%
3/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Paranoia
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
10.3%
3/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • Baseline to end of study (Approximately 8 months)
|
25.0%
5/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
7.4%
2/27 • Baseline to end of study (Approximately 8 months)
|
22.2%
4/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
20.0%
4/20 • Baseline to end of study (Approximately 8 months)
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
30.0%
6/20 • Baseline to end of study (Approximately 8 months)
|
6.9%
2/29 • Baseline to end of study (Approximately 8 months)
|
3.7%
1/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Skin irritation
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Surgical and medical procedures
Tooth repair
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
5.0%
1/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
Gastrointestinal disorders
Food poisoning
|
10.0%
2/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/18 • Baseline to end of study (Approximately 8 months)
|
|
General disorders
Discomfort
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
3.4%
1/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
5.6%
1/18 • Baseline to end of study (Approximately 8 months)
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/20 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/29 • Baseline to end of study (Approximately 8 months)
|
0.00%
0/27 • Baseline to end of study (Approximately 8 months)
|
11.1%
2/18 • Baseline to end of study (Approximately 8 months)
|
Additional Information
Berra Yazar-Klosinski, PhD / Chief Scientific Officer
Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation
Phone: (831) 429-6362
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place