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Trial record 45 of 191 for:    epidiolex

Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01844687
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Steve Sparenborg, National Institute on Drug Abuse (NIDA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Smoking, Marijuana
Intervention Drug: CBD
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Group
Hide Arm/Group Description

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

Period Title: Visit 1
Started 50
Completed 42
Not Completed 8
Reason Not Completed
Protocol Violation             3
Lost to Follow-up             5
Period Title: Visit 2
Started 42
Completed 40
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             1
Period Title: Visit 3
Started 40
Completed 35
Not Completed 5
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             3
child care problems             1
Period Title: Visit 4
Started 35
Completed 31
Not Completed 4
Reason Not Completed
Pregnancy             1
Lost to Follow-up             1
Withdrawal by Subject             2
Period Title: Visit 5
Started 31
Completed 31
Not Completed 0
Period Title: Visit 6
Started 31
Completed 31
Not Completed 0
Period Title: Visit 7
Started 31
Completed 31
Not Completed 0
Period Title: Visit 8
Started 31
Completed 31
Not Completed 0
Arm/Group Title Single Group
Hide Arm/Group Description

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

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
count - only those participants who completed all 8 visits (31)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
29.1  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
14
  45.2%
Male
17
  54.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Black 15
White 12
mixed 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
cannabis use (number of days per week)  
Mean (Standard Deviation)
Unit of measure:  Days per week
Number Analyzed 31 participants
6.5  (1.0)
cannabis cigarettes per day  
Mean (Standard Deviation)
Unit of measure:  Cannabis cigarettes used per day
Number Analyzed 31 participants
5.1  (5.3)
tobacco cigarette smokers  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
18
alcohol drinkers  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
14
1.Primary Outcome
Title Mood Scale - Subscale 'Feeling High'
Hide Description Visual analog scale range 1 (not at all) - 100 (extremely) millimeters.
Time Frame two hours before and after marijuana cigarette smoking
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Hide Analysis Population Description
all 31 completers
Arm/Group Title Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description:
a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
Overall Number of Participants Analyzed 31 31 31 31 31 31 31 31
Mean (Standard Error)
Unit of Measure: units on a scale VAS 1-100 mm
-120 mins 4.35  (2.61) 2.48  (1.24) 0.39  (0.18) 6.55  (2.69) 0.42  (0.26) 0.32  (0.19) 3.35  (2.01) 1.06  (0.79)
-30 mins 4.39  (2.22) 3.13  (1.75) 4.32  (1.83) 2.10  (1.06) 1.94  (1.37) 2.00  (1.87) 1.00  (0.68) 2.87  (1.87)
30 mins after MJ 46.65  (5.69) 45.90  (5.11) 43.32  (5.22) 36.65  (5.37) 10.52  (2.88) 17.84  (4.24) 6.23  (1.56) 13.94  (3.87)
60 mins after MJ 36.55  (5.42) 38.03  (4.72) 32.68  (4.79) 43.10  (5.54) 7.23  (2.73) 8.84  (3.08) 4.03  (1.83) 6.94  (2.54)
90 mins after MJ 24.29  (5.26) 26.87  (4.28) 15.39  (3.64) 24.90  (4.39) 4.71  (2.25) 8.39  (2.77) 2.10  (1.09) 2.48  (1.27)
120 mins after MJ 17.19  (4.60) 17.13  (3.64) 11.65  (3.04) 16.84  (3.89) 2.35  (1.47) 4.48  (1.82) 0.68  (0.33) 4.26  (2.35)
2.Other Pre-specified Outcome
Title Marijuana Rating Form - Like
Hide Description Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most
Time Frame 15 - 120 minutes after marijuana cigarette smoking
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Hide Analysis Population Description
all study completers
Arm/Group Title Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description:
a placebo comparator measuring the effect of CBD on liking the effects of smoking 5.30% THC cannabis cigarettes
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
Overall Number of Participants Analyzed 31 31 31 31 31 31 31 31
Mean (Standard Error)
Unit of Measure: units on a scale
15 minutes after smoking 55.32  (5.51) 65.87  (5.17) 61.42  (4.92) 61.94  (5.27) 25.65  (5.31) 25.03  (6.05) 22.81  (5.38) 22.48  (4.96)
30 minutes after smoking 57.10  (5.66) 57.77  (4.95) 58.77  (5.84) 60.58  (5.51) 20.16  (5.37) 24.58  (5.71) 17.97  (4.68) 18.17  (4.38)
60 minutes after smoking 52.55  (6.78) 57.90  (4.92) 53.03  (6.08) 53.26  (6.07) 14.37  (4.91) 21.32  (5.65) 16.03  (5.21) 23.52  (5.66)
90 minutes after smoking 49.58  (6.53) 51.68  (5.45) 47.84  (6.50) 50.13  (5.93) 15.97  (5.12) 18.52  (5.57) 15.06  (4.70) 17.42  (5.41)
120 minutes after smoking 41.29  (6.61) 46.00  (5.77) 42.55  (6.62) 46.81  (6.38) 14.84  (4.86) 16.81  (5.21) 14.00  (5.42) 16.48  (5.37)
3.Other Pre-specified Outcome
Title Marijuana Rating Form - Strength
Hide Description Subjects rated how strong the effects of the cannabis were using a visual analog scale.
Time Frame 15 - 120 minutes after marijuana cigarette smoking
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Hide Analysis Population Description
all study completers
Arm/Group Title Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description:
a placebo comparator measuring the effect of CBD on the strength of effects of smoking 5.30% THC cannabis cigarettes
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
Overall Number of Participants Analyzed 31 31 31 31 31 31 31 31
Mean (Standard Error)
Unit of Measure: units on a scale
15 minutes after smoking 45.68  (6.19) 58.03  (4.87) 51.48  (5.01) 51.87  (4.99) 20.32  (4.40) 20.83  (4.87) 18.52  (4.52) 16.87  (3.47)
30 minutes after smoking 55.65  (5.30) 55.03  (4.39) 48.67  (5.47) 57.61  (4.75) 14.42  (3.90) 18.94  (3.91) 11.77  (2.80) 14.83  (3.50)
60 minutes after smoking 45.84  (5.77) 44.68  (4.61) 39.71  (5.56) 45.42  (5.18) 9.03  (3.00) 13.06  (3.80) 6.39  (2.58) 11.65  (3.50)
90 minutes after smoking 27.19  (4.92) 34.97  (5.05) 28.45  (5.64) 32.52  (6.11) 7.03  (2.51) 11.19  (3.68) 6.48  (2.81) 7.94  (3.19)
120 minutes after smoking 18.68  (4.39) 22.87  (4.80) 19.42  (4.52) 28.45  (5.81) 7.55  (3.29) 8.35  (2.89) 4.65  (2.59) 7.19  (3.14)
4.Other Pre-specified Outcome
Title Optional Additional Puffs of MJ Cigarette
Hide Description 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.
Time Frame 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day
Hide Outcome Measure Data
Hide Analysis Population Description
all study completers
Arm/Group Title Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description:
MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
Overall Number of Participants Analyzed 31 31 31 31 31 31 31 31
Measure Type: Count of Participants
Unit of Measure: Participants
19
  61.3%
19
  61.3%
18
  58.1%
18
  58.1%
10
  32.3%
11
  35.5%
11
  35.5%
10
  32.3%
5.Other Pre-specified Outcome
Title Number of Optional Puffs of MJ Cigarette Taken
Hide Description Mean number of puffs taken by those participants who chose to take additional puffs.
Time Frame 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day
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Hide Analysis Population Description
Those who took additional puffs of MJ cigarette.
Arm/Group Title Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description:
MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
Overall Number of Participants Analyzed 19 19 18 18 10 11 11 10
Mean (Standard Error)
Unit of Measure: number of puffs taken per participant
1.68  (0.26) 1.71  (0.25) 1.58  (0.26) 1.55  (0.26) 0.94  (0.25) 1.00  (0.25) 1.00  (0.25) 0.97  (0.25)
6.Other Pre-specified Outcome
Title Heart Rate
Hide Description Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.
Time Frame 120 minutes before and 150 minutes after marijuana cigarette smoking
Hide Outcome Measure Data
Hide Analysis Population Description
all study completers
Arm/Group Title Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description:
MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
Overall Number of Participants Analyzed 31 31 31 31 31 31 31 31
Mean (Standard Error)
Unit of Measure: beats per minute
120 minutes before smoking 66.45  (2.42) 69.58  (2.39) 69.90  (2.31) 66.23  (2.04) 65.13  (2.09) 67.65  (1.99) 65.68  (2.15) 67.84  (2.19)
60 minutes before smoking 68.06  (2.04) 68.23  (2.22) 67.87  (2.02) 67.06  (2.10) 64.97  (1.78) 68.32  (1.70) 65.55  (1.98) 66.06  (2.09)
30 minutes before smoking 65.77  (1.92) 66.84  (2.37) 65.42  (1.75) 66.35  (1.72) 64.90  (1.62) 67.42  (1.78) 67.55  (1.77) 66.74  (2.22)
5 minutes before smoking 60.94  (1.79) 64.48  (1.97) 64.55  (1.82) 65.06  (2.12) 62.55  (1.67) 65.58  (1.74) 63.10  (1.80) 65.00  (1.98)
15 minutes after smoking 78.97  (2.62) 79.23  (2.44) 80.74  (2.89) 78.68  (2.79) 63.81  (2.03) 64.16  (1.87) 63.97  (2.05) 64.55  (1.79)
30 minutes after smoking 71.87  (2.42) 75.45  (2.36) 73.03  (2.38) 75.90  (2.89) 61.35  (1.77) 62.94  (1.86) 62.52  (1.83) 64.13  (1.72)
60 minutes after smoking 64.03  (1.96) 68.42  (2.60) 67.94  (2.15) 68.48  (2.24) 60.03  (1.72) 62.03  (1.77) 61.29  (1.65) 63.06  (1.89)
90 minutes after smoking 65.00  (1.99) 69.13  (2.19) 66.16  (2.10) 68.87  (2.01) 64.06  (1.80) 63.97  (1.94) 61.87  (2.06) 65.81  (1.94)
120 minutes after smoking 69.77  (2.22) 73.03  (2.30) 72.90  (2.36) 70.29  (2.06) 67.35  (1.90) 69.68  (2.26) 67.35  (2.24) 68.87  (2.14)
150 minutes after smoking 67.45  (1.96) 71.39  (2.18) 71.03  (2.16) 68.68  (1.81) 66.58  (1.69) 67.71  (1.87) 66.50  (2.30) 68.70  (2.11)
7.Other Pre-specified Outcome
Title Plasma Concentration of CBD
Hide Description Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.
Time Frame 6 hours
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8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples.
Arm/Group Title Plasma CBD Concentrations
Hide Arm/Group Description:
Eight of the 31 participants who completed the study came to a ninth session to receive 800 mg CBD and donate seven blood samples over six hours, one immediately before swallowing CBD capsules, and 6 throughout the next six hours. Plasma samples were analyzed through NIDA contract #NO1DA-14-7788 to David Moody, Ph.D.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/mL
baseline 0  (0)
60 minutes after dosing 11.06  (5.43)
120 minutes after dosing 38.88  (11.84)
180 minutes after dosing 77.95  (25.00)
240 minutes after dosing 77.90  (32.72)
300 minutes after dosing 50.45  (14.76)
360 minutes after dosing 64.04  (23.01)
Time Frame Adverse events reported within 72 hours of each cannabidiol administration
Adverse Event Reporting Description Cannabis strength was collapsed for each cannabidiol dose level
 
Arm/Group Title Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Hide Arm/Group Description 31 subjects were tested with 0 mg CBD and an active marijuana cigarette. 31 subjects were tested with 200 mg CBD and an active marijuana cigarette. 31 subjects were tested with 400 mg CBD and an active marijuana cigarette. 31 subjects were tested with 800 mg CBD and an active MJ cigarette. 31 subjects were tested with 0 mg CBD and an inactive MJ cigarette. 31 subjects were tested with 0 mg CBD and an inactive MJ cigarette. 31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.

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.

All-Cause Mortality
Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active MJ With 0 mg CBD Active MJ With 200 mg CBD Active MJ With 400 mg CBD Active MJ With 800 mg CBD Inactive MJ With 0 mg CBD Inactive MJ With 200 mg CBD Inactive MJ With 400 mg CBD Inactive MJ With 800 mg CBD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/50 (10.00%)      8/50 (16.00%)      4/50 (8.00%)      3/50 (6.00%)      2/50 (4.00%)      1/50 (2.00%)      3/50 (6.00%)      6/50 (12.00%)    
Cardiac disorders                 
Increased heart rate * 1  0/50 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0
Eye disorders                 
Blurred Vision * 1  1/50 (2.00%)  1 0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal disorders                 
Gastrointestinal Upset * 1  1/50 (2.00%)  1 2/50 (4.00%)  2 0/50 (0.00%)  0 2/50 (4.00%)  2 0/50 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1 3/50 (6.00%)  3
General disorders                 
fatigue * 1  0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0
Infections and infestations                 
Cold Symptoms * 1  1/50 (2.00%)  1 0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders                 
Pain (foot/hand/tooth) * 1  0/50 (0.00%)  0 2/50 (4.00%)  2 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0
Nervous system disorders                 
headache * 1  1/50 (2.00%)  1 1/50 (2.00%)  1 1/50 (2.00%)  1 1/50 (2.00%)  1 1/50 (2.00%)  1 1/50 (2.00%)  1 1/50 (2.00%)  1 1/50 (2.00%)  1
Psychiatric disorders                 
anxiety * 1  1/50 (2.00%)  1 3/50 (6.00%)  3 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0 0/50 (0.00%)  0
1
Term from vocabulary, other
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Margaret Haney, PhD., Professor
Organization: Columbia University Medical Center
Phone: (646) 774-6153
Responsible Party: Steve Sparenborg, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01844687     History of Changes
Other Study ID Numbers: Study Number CBD-001
First Submitted: April 29, 2013
First Posted: May 1, 2013
Results First Submitted: January 7, 2017
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017