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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Completed
CT.gov ID
NCT01844687
Collaborator
(none)
50
Enrollment
3
Locations
8
Arms
17
Duration (Months)
16.7
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Marijuana contains many chemicals called cannabinoids. The ingredient mainly responsible for marijuana's psychoactive effects is called THC (delta-9-tetrahydrocannabinol. Another cannabinoid in marijuana is cannabidiol. It is found in smaller quantities than THC. Cannabidiol is thought to interfere with the effects of THC. Therefore, synthetically produced cannabidiol is given to healthy marijuana users in this study to test its capability to reduce the high of THC and, thereby, help to relieve addiction to marijuana.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Active marijuana (MJ) with 0 mg CBD

Active MJ cigarettes contain 5.30% THC

Drug: CBD
Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Active MJ with 200 mg CBD

    Active MJ cigarettes contain 5.30% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Active MJ with 400 mg CBD

    Active MJ cigarettes contain 5.30% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Active MJ with 800 mg CBD

    Active MJ cigarettes contain 5.30% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Inactive MJ with 0 mg CBD

    Inactive MJ cigarettes contain 0.01% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Inactive MJ with 200 mg CBD

    Inactive MJ cigarettes contain 0.01% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Inactive MJ with 400 mg CBD

    Inactive MJ cigarettes contain 0.01% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•
    Other: Inactive MJ with 800 mg CBD

    Inactive MJ cigarettes contain 0.01% THC

    Drug: CBD
    Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
    Other Names:
  • cannabidiol is abbreviated CBD

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mood Scale - Subscale 'Feeling High' [two hours before and after marijuana cigarette smoking]

      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).

    Other Outcome Measures

    1. Marijuana Rating Form - Like [15 - 120 minutes after marijuana cigarette smoking]

      Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most

    2. Marijuana Rating Form - Strength [15 - 120 minutes after marijuana cigarette smoking]

      Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most

    3. Optional Additional Puffs of MJ Cigarette [150 to 250 minutes after first marijuana cigarette was smoked earlier in the day]

      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.

    4. Number of Optional Puffs of MJ Cigarette Taken [150 to 160 minutes after first marijuana cigarette was smoked earlier in the day]

      Mean number of puffs taken by those participants who chose to take additional puffs.

    5. Heart Rate [120 minutes before and 150 minutes after marijuana cigarette smoking]

      Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.

    6. Plasma Concentration of CBD [6 hours]

      Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults between the ages of 18 and 50.

    • Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.

    • Able to perform study procedures

    • Women practicing an effective form of birth control

    Exclusion Criteria:

    • Female subjects who are currently pregnant or breastfeeding.

    • Current, repeated illicit drug use other than marijuana

    • Presence of significant medical illness

    • History of heart disease

    • Request for drug treatment

    • Current parole or probation

    • Recent history of significant violent behavior

    • Major psychiatric disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct. Lexington Kentucky United States 40513
    2 Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120 New York New York United States 10032
    3 Center for Drug and Alcohol Programs, Room 459 North, 67 President St. Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Principal Investigator: Margaret Haney, M.D., New York State Psychiatric Institute
    • Study Director: Robert J Malcolm, M.D., Medical University of South Carolina
    • Study Director: Sharon Walsh, Ph.D., University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute on Drug Abuse (NIDA)
    ClinicalTrials.gov Identifier:
    NCT01844687
    Other Study ID Numbers:
    • Study Number CBD-001
    First Posted:
    May 1, 2013
    Last Update Posted:
    Dec 9, 2019
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by National Institute on Drug Abuse (NIDA)
    reinforcement, good drug effect, high, mood, cannabidiol
    Additional relevant MeSH terms:
    Marijuana Abuse
    Marijuana Use
    Cannabidiol

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Single Group
    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
    Period Title: Visit 1
    STARTED 42
    COMPLETED 40
    NOT COMPLETED 2
    Period Title: Visit 1
    STARTED 40
    COMPLETED 35
    NOT COMPLETED 5
    Period Title: Visit 1
    STARTED 35
    COMPLETED 31
    NOT COMPLETED 4
    Period Title: Visit 1
    STARTED 31
    COMPLETED 31
    NOT COMPLETED 0
    Period Title: Visit 1
    STARTED 31
    COMPLETED 31
    NOT COMPLETED 0
    Period Title: Visit 1
    STARTED 31
    COMPLETED 31
    NOT COMPLETED 0
    Period Title: Visit 1
    STARTED 31
    COMPLETED 31
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Single Group
    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 Participants 31
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    29.1
    (9.1)
    Sex: Female, Male (Count of Participants)
    Female
    14
    45.2%
    Male
    17
    54.8%
    Race/Ethnicity, Customized (participants) [Number]
    Black
    15
    48.4%
    White
    12
    38.7%
    mixed
    4
    12.9%
    Region of Enrollment (participants) [Number]
    United States
    31
    100%
    cannabis use (number of days per week) (days per week) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days per week]
    6.5
    (1.0)
    cannabis cigarettes per day (cannabis cigarettes used per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cannabis cigarettes used per day]
    5.1
    (5.3)
    tobacco cigarette smokers (participants) [Number]
    Number [participants]
    18
    58.1%
    alcohol drinkers (participants) [Number]
    Number [participants]
    14
    45.2%

    Outcome Measures

    1. Primary Outcome
    Title Mood Scale - Subscale 'Feeling High'
    Description 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).
    Time Frame two hours before and after marijuana cigarette smoking

    Outcome Measure Data

    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
    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
    Measure Participants 31 31 31 31 31 31 31 31
    -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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 31 31 31 31 31 31 31 31
    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
    Description Participants rated the strength 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

    Outcome Measure Data

    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
    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
    Measure Participants 31 31 31 31 31 31 31 31
    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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 31 31 31 31 31 31 31 31
    Count of Participants [Participants]
    19
    61.3%
    19
    NaN
    18
    NaN
    18
    NaN
    10
    NaN
    11
    NaN
    11
    NaN
    10
    NaN
    5. Other Pre-specified Outcome
    Title Number of Optional Puffs of MJ Cigarette Taken
    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

    Outcome Measure Data

    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
    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
    Measure Participants 19 19 18 18 10 11 11 10
    Mean (Standard Error) [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
    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

    Outcome Measure Data

    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
    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
    Measure Participants 31 31 31 31 31 31 31 31
    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
    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

    Outcome Measure Data

    Analysis Population Description
    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
    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.
    Measure Participants 8
    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)

    Adverse Events

    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
    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 (%) # 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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%)
    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%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%)
    Other (Not Including 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 5/50 (10%) 8/50 (16%) 4/50 (8%) 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 6/50 (12%)
    Cardiac disorders
    Increased heart rate 0/50 (0%) 0 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0
    Eye disorders
    Blurred Vision 1/50 (2%) 1 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0 0/50 (0%) 0 1/5 (20%) 1
    Gastrointestinal disorders
    Gastrointestinal Upset 1/50 (2%) 1 2/50 (4%) 2 0/50 (0%) 0 2/50 (4%) 2 0/50 (0%) 0 0/50 (0%) 0 1/50 (2%) 1 3/50 (6%) 3
    General disorders
    fatigue 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0
    Infections and infestations
    Cold Symptoms 1/50 (2%) 1 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 1/50 (2%) 1
    Musculoskeletal and connective tissue disorders
    Pain (foot/hand/tooth) 0/50 (0%) 0 2/50 (4%) 2 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 1/50 (2%) 1 0/50 (0%) 0
    Nervous system disorders
    headache 1/50 (2%) 1 1/50 (2%) 1 1/50 (2%) 1 1/50 (2%) 1 1/50 (2%) 1 1/50 (2%) 1 1/50 (2%) 1 1/50 (2%) 1
    Psychiatric disorders
    anxiety 1/50 (2%) 1 3/50 (6%) 3 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0 0/50 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    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
    Email mh235@columbia.edu
    Responsible Party:
    National Institute on Drug Abuse (NIDA)
    ClinicalTrials.gov Identifier:
    NCT01844687
    Other Study ID Numbers:
    • Study Number CBD-001
    First Posted:
    May 1, 2013
    Last Update Posted:
    Dec 9, 2019
    Last Verified:
    Apr 1, 2017