Trial Outcomes & Findings for Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana (NCT NCT01844687)
NCT ID: NCT01844687
Last Updated: 2019-12-09
Results Overview
Participants rated how much they felt having a "high" feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
two hours before and after marijuana cigarette smoking
Results posted on
2019-12-09
Participant Flow
Participant milestones
| Measure |
Single Group
Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol
A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion
|
|---|---|
|
Visit 1
STARTED
|
50
|
|
Visit 1
COMPLETED
|
42
|
|
Visit 1
NOT COMPLETED
|
8
|
|
Visit 2
STARTED
|
42
|
|
Visit 2
COMPLETED
|
40
|
|
Visit 2
NOT COMPLETED
|
2
|
|
Visit 3
STARTED
|
40
|
|
Visit 3
COMPLETED
|
35
|
|
Visit 3
NOT COMPLETED
|
5
|
|
Visit 4
STARTED
|
35
|
|
Visit 4
COMPLETED
|
31
|
|
Visit 4
NOT COMPLETED
|
4
|
|
Visit 5
STARTED
|
31
|
|
Visit 5
COMPLETED
|
31
|
|
Visit 5
NOT COMPLETED
|
0
|
|
Visit 6
STARTED
|
31
|
|
Visit 6
COMPLETED
|
31
|
|
Visit 6
NOT COMPLETED
|
0
|
|
Visit 7
STARTED
|
31
|
|
Visit 7
COMPLETED
|
31
|
|
Visit 7
NOT COMPLETED
|
0
|
|
Visit 8
STARTED
|
31
|
|
Visit 8
COMPLETED
|
31
|
|
Visit 8
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Single Group
Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol
A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion
|
|---|---|
|
Visit 1
Protocol Violation
|
3
|
|
Visit 1
Lost to Follow-up
|
5
|
|
Visit 2
Withdrawal by Subject
|
1
|
|
Visit 2
Protocol Violation
|
1
|
|
Visit 3
Lost to Follow-up
|
1
|
|
Visit 3
Withdrawal by Subject
|
3
|
|
Visit 3
child care problems
|
1
|
|
Visit 4
Pregnancy
|
1
|
|
Visit 4
Lost to Follow-up
|
1
|
|
Visit 4
Withdrawal by Subject
|
2
|
Baseline Characteristics
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Baseline characteristics by cohort
| Measure |
Single Group
n=31 Participants
Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol
A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion
|
|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
mixed
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
|
cannabis use (number of days per week)
|
6.5 days per week
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
cannabis cigarettes per day
|
5.1 cannabis cigarettes used per day
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
tobacco cigarette smokers
|
18 participants
n=5 Participants
|
|
alcohol drinkers
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two hours before and after marijuana cigarette smokingPopulation: all 31 completers
Participants rated how much they felt having a "high" feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely).
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=31 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Mood Scale - Subscale 'Feeling High'
60 mins after MJ
|
36.55 units on a scale VAS 1-100 mm
Standard Error 5.42
|
38.03 units on a scale VAS 1-100 mm
Standard Error 4.72
|
32.68 units on a scale VAS 1-100 mm
Standard Error 4.79
|
43.10 units on a scale VAS 1-100 mm
Standard Error 5.54
|
7.23 units on a scale VAS 1-100 mm
Standard Error 2.73
|
8.84 units on a scale VAS 1-100 mm
Standard Error 3.08
|
4.03 units on a scale VAS 1-100 mm
Standard Error 1.83
|
6.94 units on a scale VAS 1-100 mm
Standard Error 2.54
|
|
Mood Scale - Subscale 'Feeling High'
-120 mins
|
4.35 units on a scale VAS 1-100 mm
Standard Error 2.61
|
2.48 units on a scale VAS 1-100 mm
Standard Error 1.24
|
0.39 units on a scale VAS 1-100 mm
Standard Error 0.18
|
6.55 units on a scale VAS 1-100 mm
Standard Error 2.69
|
0.42 units on a scale VAS 1-100 mm
Standard Error 0.26
|
0.32 units on a scale VAS 1-100 mm
Standard Error 0.19
|
3.35 units on a scale VAS 1-100 mm
Standard Error 2.01
|
1.06 units on a scale VAS 1-100 mm
Standard Error 0.79
|
|
Mood Scale - Subscale 'Feeling High'
-30 mins
|
4.39 units on a scale VAS 1-100 mm
Standard Error 2.22
|
3.13 units on a scale VAS 1-100 mm
Standard Error 1.75
|
4.32 units on a scale VAS 1-100 mm
Standard Error 1.83
|
2.10 units on a scale VAS 1-100 mm
Standard Error 1.06
|
1.94 units on a scale VAS 1-100 mm
Standard Error 1.37
|
2.00 units on a scale VAS 1-100 mm
Standard Error 1.87
|
1.00 units on a scale VAS 1-100 mm
Standard Error 0.68
|
2.87 units on a scale VAS 1-100 mm
Standard Error 1.87
|
|
Mood Scale - Subscale 'Feeling High'
30 mins after MJ
|
46.65 units on a scale VAS 1-100 mm
Standard Error 5.69
|
45.90 units on a scale VAS 1-100 mm
Standard Error 5.11
|
43.32 units on a scale VAS 1-100 mm
Standard Error 5.22
|
36.65 units on a scale VAS 1-100 mm
Standard Error 5.37
|
10.52 units on a scale VAS 1-100 mm
Standard Error 2.88
|
17.84 units on a scale VAS 1-100 mm
Standard Error 4.24
|
6.23 units on a scale VAS 1-100 mm
Standard Error 1.56
|
13.94 units on a scale VAS 1-100 mm
Standard Error 3.87
|
|
Mood Scale - Subscale 'Feeling High'
90 mins after MJ
|
24.29 units on a scale VAS 1-100 mm
Standard Error 5.26
|
26.87 units on a scale VAS 1-100 mm
Standard Error 4.28
|
15.39 units on a scale VAS 1-100 mm
Standard Error 3.64
|
24.90 units on a scale VAS 1-100 mm
Standard Error 4.39
|
4.71 units on a scale VAS 1-100 mm
Standard Error 2.25
|
8.39 units on a scale VAS 1-100 mm
Standard Error 2.77
|
2.10 units on a scale VAS 1-100 mm
Standard Error 1.09
|
2.48 units on a scale VAS 1-100 mm
Standard Error 1.27
|
|
Mood Scale - Subscale 'Feeling High'
120 mins after MJ
|
17.19 units on a scale VAS 1-100 mm
Standard Error 4.60
|
17.13 units on a scale VAS 1-100 mm
Standard Error 3.64
|
11.65 units on a scale VAS 1-100 mm
Standard Error 3.04
|
16.84 units on a scale VAS 1-100 mm
Standard Error 3.89
|
2.35 units on a scale VAS 1-100 mm
Standard Error 1.47
|
4.48 units on a scale VAS 1-100 mm
Standard Error 1.82
|
0.68 units on a scale VAS 1-100 mm
Standard Error 0.33
|
4.26 units on a scale VAS 1-100 mm
Standard Error 2.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 - 120 minutes after marijuana cigarette smokingPopulation: all study completers
Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=31 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Marijuana Rating Form - Like
15 minutes after smoking
|
55.32 units on a scale
Standard Error 5.51
|
65.87 units on a scale
Standard Error 5.17
|
61.42 units on a scale
Standard Error 4.92
|
61.94 units on a scale
Standard Error 5.27
|
25.65 units on a scale
Standard Error 5.31
|
25.03 units on a scale
Standard Error 6.05
|
22.81 units on a scale
Standard Error 5.38
|
22.48 units on a scale
Standard Error 4.96
|
|
Marijuana Rating Form - Like
30 minutes after smoking
|
57.10 units on a scale
Standard Error 5.66
|
57.77 units on a scale
Standard Error 4.95
|
58.77 units on a scale
Standard Error 5.84
|
60.58 units on a scale
Standard Error 5.51
|
20.16 units on a scale
Standard Error 5.37
|
24.58 units on a scale
Standard Error 5.71
|
17.97 units on a scale
Standard Error 4.68
|
18.17 units on a scale
Standard Error 4.38
|
|
Marijuana Rating Form - Like
60 minutes after smoking
|
52.55 units on a scale
Standard Error 6.78
|
57.90 units on a scale
Standard Error 4.92
|
53.03 units on a scale
Standard Error 6.08
|
53.26 units on a scale
Standard Error 6.07
|
14.37 units on a scale
Standard Error 4.91
|
21.32 units on a scale
Standard Error 5.65
|
16.03 units on a scale
Standard Error 5.21
|
23.52 units on a scale
Standard Error 5.66
|
|
Marijuana Rating Form - Like
90 minutes after smoking
|
49.58 units on a scale
Standard Error 6.53
|
51.68 units on a scale
Standard Error 5.45
|
47.84 units on a scale
Standard Error 6.50
|
50.13 units on a scale
Standard Error 5.93
|
15.97 units on a scale
Standard Error 5.12
|
18.52 units on a scale
Standard Error 5.57
|
15.06 units on a scale
Standard Error 4.70
|
17.42 units on a scale
Standard Error 5.41
|
|
Marijuana Rating Form - Like
120 minutes after smoking
|
41.29 units on a scale
Standard Error 6.61
|
46.00 units on a scale
Standard Error 5.77
|
42.55 units on a scale
Standard Error 6.62
|
46.81 units on a scale
Standard Error 6.38
|
14.84 units on a scale
Standard Error 4.86
|
16.81 units on a scale
Standard Error 5.21
|
14.00 units on a scale
Standard Error 5.42
|
16.48 units on a scale
Standard Error 5.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 - 120 minutes after marijuana cigarette smokingPopulation: all study completers
Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=31 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Marijuana Rating Form - Strength
60 minutes after smoking
|
45.84 units on a scale
Standard Error 5.77
|
44.68 units on a scale
Standard Error 4.61
|
39.71 units on a scale
Standard Error 5.56
|
45.42 units on a scale
Standard Error 5.18
|
9.03 units on a scale
Standard Error 3.00
|
13.06 units on a scale
Standard Error 3.80
|
6.39 units on a scale
Standard Error 2.58
|
11.65 units on a scale
Standard Error 3.50
|
|
Marijuana Rating Form - Strength
15 minutes after smoking
|
45.68 units on a scale
Standard Error 6.19
|
58.03 units on a scale
Standard Error 4.87
|
51.48 units on a scale
Standard Error 5.01
|
51.87 units on a scale
Standard Error 4.99
|
20.32 units on a scale
Standard Error 4.40
|
20.83 units on a scale
Standard Error 4.87
|
18.52 units on a scale
Standard Error 4.52
|
16.87 units on a scale
Standard Error 3.47
|
|
Marijuana Rating Form - Strength
30 minutes after smoking
|
55.65 units on a scale
Standard Error 5.30
|
55.03 units on a scale
Standard Error 4.39
|
48.67 units on a scale
Standard Error 5.47
|
57.61 units on a scale
Standard Error 4.75
|
14.42 units on a scale
Standard Error 3.90
|
18.94 units on a scale
Standard Error 3.91
|
11.77 units on a scale
Standard Error 2.80
|
14.83 units on a scale
Standard Error 3.50
|
|
Marijuana Rating Form - Strength
90 minutes after smoking
|
27.19 units on a scale
Standard Error 4.92
|
34.97 units on a scale
Standard Error 5.05
|
28.45 units on a scale
Standard Error 5.64
|
32.52 units on a scale
Standard Error 6.11
|
7.03 units on a scale
Standard Error 2.51
|
11.19 units on a scale
Standard Error 3.68
|
6.48 units on a scale
Standard Error 2.81
|
7.94 units on a scale
Standard Error 3.19
|
|
Marijuana Rating Form - Strength
120 minutes after smoking
|
18.68 units on a scale
Standard Error 4.39
|
22.87 units on a scale
Standard Error 4.80
|
19.42 units on a scale
Standard Error 4.52
|
28.45 units on a scale
Standard Error 5.81
|
7.55 units on a scale
Standard Error 3.29
|
8.35 units on a scale
Standard Error 2.89
|
4.65 units on a scale
Standard Error 2.59
|
7.19 units on a scale
Standard Error 3.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 150 to 250 minutes after first marijuana cigarette was smoked earlier in the dayPopulation: all study completers
Participants were allowed to choose to take or reject additional puffs of the same type of MJ cigarette they smoked earlier in the day. Counts of participants choosing to take additional puffs are reported.
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=31 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Optional Additional Puffs of MJ Cigarette
|
19 Participants
|
19 Participants
|
18 Participants
|
18 Participants
|
10 Participants
|
11 Participants
|
11 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 150 to 160 minutes after first marijuana cigarette was smoked earlier in the dayPopulation: Those who took additional puffs of MJ cigarette.
Mean number of puffs taken by those participants who chose to take additional puffs.
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=19 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
n=19 Participants
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
n=18 Participants
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
n=18 Participants
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
n=10 Participants
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
n=11 Participants
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
n=11 Participants
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
n=10 Participants
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Number of Optional Puffs of MJ Cigarette Taken
|
1.68 number of puffs taken per participant
Standard Error 0.26
|
1.71 number of puffs taken per participant
Standard Error 0.25
|
1.58 number of puffs taken per participant
Standard Error 0.26
|
1.55 number of puffs taken per participant
Standard Error 0.26
|
0.94 number of puffs taken per participant
Standard Error 0.25
|
1.00 number of puffs taken per participant
Standard Error 0.25
|
1.00 number of puffs taken per participant
Standard Error 0.25
|
0.97 number of puffs taken per participant
Standard Error 0.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 120 minutes before and 150 minutes after marijuana cigarette smokingPopulation: all study completers
Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=31 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
n=31 Participants
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Heart Rate
30 minutes before smoking
|
65.77 beats per minute
Standard Error 1.92
|
66.84 beats per minute
Standard Error 2.37
|
65.42 beats per minute
Standard Error 1.75
|
66.35 beats per minute
Standard Error 1.72
|
64.90 beats per minute
Standard Error 1.62
|
67.42 beats per minute
Standard Error 1.78
|
67.55 beats per minute
Standard Error 1.77
|
66.74 beats per minute
Standard Error 2.22
|
|
Heart Rate
120 minutes after smoking
|
69.77 beats per minute
Standard Error 2.22
|
73.03 beats per minute
Standard Error 2.30
|
72.90 beats per minute
Standard Error 2.36
|
70.29 beats per minute
Standard Error 2.06
|
67.35 beats per minute
Standard Error 1.90
|
69.68 beats per minute
Standard Error 2.26
|
67.35 beats per minute
Standard Error 2.24
|
68.87 beats per minute
Standard Error 2.14
|
|
Heart Rate
120 minutes before smoking
|
66.45 beats per minute
Standard Error 2.42
|
69.58 beats per minute
Standard Error 2.39
|
69.90 beats per minute
Standard Error 2.31
|
66.23 beats per minute
Standard Error 2.04
|
65.13 beats per minute
Standard Error 2.09
|
67.65 beats per minute
Standard Error 1.99
|
65.68 beats per minute
Standard Error 2.15
|
67.84 beats per minute
Standard Error 2.19
|
|
Heart Rate
60 minutes before smoking
|
68.06 beats per minute
Standard Error 2.04
|
68.23 beats per minute
Standard Error 2.22
|
67.87 beats per minute
Standard Error 2.02
|
67.06 beats per minute
Standard Error 2.10
|
64.97 beats per minute
Standard Error 1.78
|
68.32 beats per minute
Standard Error 1.70
|
65.55 beats per minute
Standard Error 1.98
|
66.06 beats per minute
Standard Error 2.09
|
|
Heart Rate
5 minutes before smoking
|
60.94 beats per minute
Standard Error 1.79
|
64.48 beats per minute
Standard Error 1.97
|
64.55 beats per minute
Standard Error 1.82
|
65.06 beats per minute
Standard Error 2.12
|
62.55 beats per minute
Standard Error 1.67
|
65.58 beats per minute
Standard Error 1.74
|
63.10 beats per minute
Standard Error 1.80
|
65.00 beats per minute
Standard Error 1.98
|
|
Heart Rate
15 minutes after smoking
|
78.97 beats per minute
Standard Error 2.62
|
79.23 beats per minute
Standard Error 2.44
|
80.74 beats per minute
Standard Error 2.89
|
78.68 beats per minute
Standard Error 2.79
|
63.81 beats per minute
Standard Error 2.03
|
64.16 beats per minute
Standard Error 1.87
|
63.97 beats per minute
Standard Error 2.05
|
64.55 beats per minute
Standard Error 1.79
|
|
Heart Rate
30 minutes after smoking
|
71.87 beats per minute
Standard Error 2.42
|
75.45 beats per minute
Standard Error 2.36
|
73.03 beats per minute
Standard Error 2.38
|
75.90 beats per minute
Standard Error 2.89
|
61.35 beats per minute
Standard Error 1.77
|
62.94 beats per minute
Standard Error 1.86
|
62.52 beats per minute
Standard Error 1.83
|
64.13 beats per minute
Standard Error 1.72
|
|
Heart Rate
60 minutes after smoking
|
64.03 beats per minute
Standard Error 1.96
|
68.42 beats per minute
Standard Error 2.60
|
67.94 beats per minute
Standard Error 2.15
|
68.48 beats per minute
Standard Error 2.24
|
60.03 beats per minute
Standard Error 1.72
|
62.03 beats per minute
Standard Error 1.77
|
61.29 beats per minute
Standard Error 1.65
|
63.06 beats per minute
Standard Error 1.89
|
|
Heart Rate
90 minutes after smoking
|
65.00 beats per minute
Standard Error 1.99
|
69.13 beats per minute
Standard Error 2.19
|
66.16 beats per minute
Standard Error 2.10
|
68.87 beats per minute
Standard Error 2.01
|
64.06 beats per minute
Standard Error 1.80
|
63.97 beats per minute
Standard Error 1.94
|
61.87 beats per minute
Standard Error 2.06
|
65.81 beats per minute
Standard Error 1.94
|
|
Heart Rate
150 minutes after smoking
|
67.45 beats per minute
Standard Error 1.96
|
71.39 beats per minute
Standard Error 2.18
|
71.03 beats per minute
Standard Error 2.16
|
68.68 beats per minute
Standard Error 1.81
|
66.58 beats per minute
Standard Error 1.69
|
67.71 beats per minute
Standard Error 1.87
|
66.50 beats per minute
Standard Error 2.30
|
68.70 beats per minute
Standard Error 2.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 hoursPopulation: 8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples.
Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.
Outcome measures
| Measure |
Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)
n=8 Participants
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
|
Active MJ With 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
|
Active MJ With 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
|
Active MJ With 800 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
|
Inactive MJ With 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
|
Inactive MJ With 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
|
Inactive MJ With 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
|
Inactive MJ With 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of CBD
baseline
|
0 ng/mL
Standard Error 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of CBD
60 minutes after dosing
|
11.06 ng/mL
Standard Error 5.43
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of CBD
120 minutes after dosing
|
38.88 ng/mL
Standard Error 11.84
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of CBD
180 minutes after dosing
|
77.95 ng/mL
Standard Error 25.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of CBD
240 minutes after dosing
|
77.90 ng/mL
Standard Error 32.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of CBD
300 minutes after dosing
|
50.45 ng/mL
Standard Error 14.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of CBD
360 minutes after dosing
|
64.04 ng/mL
Standard Error 23.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Active MJ With 0 mg CBD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active MJ With 200 mg CBD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Active MJ With 400 mg CBD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Active MJ With 800 mg CBD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Inactive MJ With 0 mg CBD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Inactive MJ With 200 mg CBD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Inactive MJ With 400 mg CBD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Inactive MJ With 800 mg CBD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active MJ With 0 mg CBD
n=50 participants at risk
31 subjects were tested with 0 mg CBD and an active marijuana cigarette.
|
Active MJ With 200 mg CBD
n=50 participants at risk
31 subjects were tested with 200 mg CBD and an active marijuana cigarette.
|
Active MJ With 400 mg CBD
n=50 participants at risk
31 subjects were tested with 400 mg CBD and an active marijuana cigarette.
|
Active MJ With 800 mg CBD
n=50 participants at risk
31 subjects were tested with 800 mg CBD and an active MJ cigarette.
|
Inactive MJ With 0 mg CBD
n=50 participants at risk
31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
|
Inactive MJ With 200 mg CBD
n=50 participants at risk
31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
|
Inactive MJ With 400 mg CBD
n=50 participants at risk
31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.
|
Inactive MJ With 800 mg CBD
n=50 participants at risk
31 subjects were tested with 800 mg CBD and Inactive MJ cigarette.
8 of the 31 study completers were given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion. No MJ cigarette was smoked during this session. Adverse events reported during this session are included here.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Blurred Vision
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
20.0%
1/5 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
4.0%
2/50 • Number of events 2 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
4.0%
2/50 • Number of events 2 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
6.0%
3/50 • Number of events 3 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
Nervous system disorders
headache
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
Psychiatric disorders
anxiety
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
6.0%
3/50 • Number of events 3 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
General disorders
fatigue
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
Infections and infestations
Cold Symptoms
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
Musculoskeletal and connective tissue disorders
Pain (foot/hand/tooth)
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
4.0%
2/50 • Number of events 2 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
|
Cardiac disorders
Increased heart rate
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
2.0%
1/50 • Number of events 1 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
0.00%
0/50 • Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
|
Additional Information
Margaret Haney, PhD., Professor
Columbia University Medical Center
Phone: (646) 774-6153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place