Smoking, Marijuana
Conditions
Keywords
reinforcement, good drug effect, high, mood, cannabidiol
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.
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.
Interventions
DRUGCBD
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Visit 1 | Lost to Follow-up | 5 |
| Visit 1 | Protocol Violation | 3 |
| Visit 2 | Protocol Violation | 1 |
| Visit 2 | Withdrawal by Subject | 1 |
| Visit 3 | child care problems | 1 |
| Visit 3 | Lost to Follow-up | 1 |
| Visit 3 | Withdrawal by Subject | 3 |
| Visit 4 | Lost to Follow-up | 1 |
| Visit 4 | Pregnancy | 1 |
| Visit 4 | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 9.1 |
| alcohol drinkers | 14 participants |
| cannabis cigarettes per day | 5.1 cannabis cigarettes used per day STANDARD_DEVIATION 5.3 |
| cannabis use (number of days per week) | 6.5 days per week STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized Black | 15 participants |
| Race/Ethnicity, Customized mixed | 4 participants |
| Race/Ethnicity, Customized White | 12 participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 17 Participants |
| tobacco cigarette smokers | 18 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 5 / 50 | 8 / 50 | 4 / 50 | 3 / 50 | 2 / 50 | 1 / 50 | 3 / 50 | 6 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Mood Scale - Subscale 'Feeling High'
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
Population: all 31 completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 17.19 units on a scale VAS 1-100 mm | Standard Error 4.6 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Mood Scale - Subscale 'Feeling High' | -120 mins | 4.35 units on a scale VAS 1-100 mm | Standard Error 2.61 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Mood Scale - Subscale 'Feeling High' | -30 mins | 4.39 units on a scale VAS 1-100 mm | Standard Error 2.22 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 46.65 units on a scale VAS 1-100 mm | Standard Error 5.69 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 24.29 units on a scale VAS 1-100 mm | Standard Error 5.26 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 36.55 units on a scale VAS 1-100 mm | Standard Error 5.42 |
| Active MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 45.90 units on a scale VAS 1-100 mm | Standard Error 5.11 |
| Active MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 2.48 units on a scale VAS 1-100 mm | Standard Error 1.24 |
| Active MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 38.03 units on a scale VAS 1-100 mm | Standard Error 4.72 |
| Active MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 17.13 units on a scale VAS 1-100 mm | Standard Error 3.64 |
| Active MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 3.13 units on a scale VAS 1-100 mm | Standard Error 1.75 |
| Active MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 26.87 units on a scale VAS 1-100 mm | Standard Error 4.28 |
| Active MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 15.39 units on a scale VAS 1-100 mm | Standard Error 3.64 |
| Active MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 43.32 units on a scale VAS 1-100 mm | Standard Error 5.22 |
| Active MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 4.32 units on a scale VAS 1-100 mm | Standard Error 1.83 |
| Active MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 32.68 units on a scale VAS 1-100 mm | Standard Error 4.79 |
| Active MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 11.65 units on a scale VAS 1-100 mm | Standard Error 3.04 |
| Active MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 0.39 units on a scale VAS 1-100 mm | Standard Error 0.18 |
| Active MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 24.90 units on a scale VAS 1-100 mm | Standard Error 4.39 |
| Active MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 6.55 units on a scale VAS 1-100 mm | Standard Error 2.69 |
| Active MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 2.10 units on a scale VAS 1-100 mm | Standard Error 1.06 |
| Active MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 36.65 units on a scale VAS 1-100 mm | Standard Error 5.37 |
| Active MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 43.10 units on a scale VAS 1-100 mm | Standard Error 5.54 |
| Active MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 16.84 units on a scale VAS 1-100 mm | Standard Error 3.89 |
| Inactive MJ With 0 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 4.71 units on a scale VAS 1-100 mm | Standard Error 2.25 |
| Inactive MJ With 0 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 1.94 units on a scale VAS 1-100 mm | Standard Error 1.37 |
| Inactive MJ With 0 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 2.35 units on a scale VAS 1-100 mm | Standard Error 1.47 |
| Inactive MJ With 0 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 0.42 units on a scale VAS 1-100 mm | Standard Error 0.26 |
| Inactive MJ With 0 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 7.23 units on a scale VAS 1-100 mm | Standard Error 2.73 |
| Inactive MJ With 0 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 10.52 units on a scale VAS 1-100 mm | Standard Error 2.88 |
| Inactive MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 17.84 units on a scale VAS 1-100 mm | Standard Error 4.24 |
| Inactive MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 8.84 units on a scale VAS 1-100 mm | Standard Error 3.08 |
| Inactive MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 2.00 units on a scale VAS 1-100 mm | Standard Error 1.87 |
| Inactive MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 8.39 units on a scale VAS 1-100 mm | Standard Error 2.77 |
| Inactive MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 0.32 units on a scale VAS 1-100 mm | Standard Error 0.19 |
| Inactive MJ With 200 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 4.48 units on a scale VAS 1-100 mm | Standard Error 1.82 |
| Inactive MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 4.03 units on a scale VAS 1-100 mm | Standard Error 1.83 |
| Inactive MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 2.10 units on a scale VAS 1-100 mm | Standard Error 1.09 |
| Inactive MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 3.35 units on a scale VAS 1-100 mm | Standard Error 2.01 |
| Inactive MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 6.23 units on a scale VAS 1-100 mm | Standard Error 1.56 |
| Inactive MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 0.68 units on a scale VAS 1-100 mm | Standard Error 0.33 |
| Inactive MJ With 400 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 1.00 units on a scale VAS 1-100 mm | Standard Error 0.68 |
| Inactive MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 60 mins after MJ | 6.94 units on a scale VAS 1-100 mm | Standard Error 2.54 |
| Inactive MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 30 mins after MJ | 13.94 units on a scale VAS 1-100 mm | Standard Error 3.87 |
| Inactive MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 120 mins after MJ | 4.26 units on a scale VAS 1-100 mm | Standard Error 2.35 |
| Inactive MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | 90 mins after MJ | 2.48 units on a scale VAS 1-100 mm | Standard Error 1.27 |
| Inactive MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | -120 mins | 1.06 units on a scale VAS 1-100 mm | Standard Error 0.79 |
| Inactive MJ With 800 mg CBD | Mood Scale - Subscale 'Feeling High' | -30 mins | 2.87 units on a scale VAS 1-100 mm | Standard Error 1.87 |
Other Pre-specified
Heart Rate
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
Population: all study completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 120 minutes after smoking | 69.77 beats per minute | Standard Error 2.22 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 30 minutes before smoking | 65.77 beats per minute | Standard Error 1.92 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 60 minutes before smoking | 68.06 beats per minute | Standard Error 2.04 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 15 minutes after smoking | 78.97 beats per minute | Standard Error 2.62 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 90 minutes after smoking | 65.00 beats per minute | Standard Error 1.99 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 120 minutes before smoking | 66.45 beats per minute | Standard Error 2.42 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 30 minutes after smoking | 71.87 beats per minute | Standard Error 2.42 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 60 minutes after smoking | 64.03 beats per minute | Standard Error 1.96 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 150 minutes after smoking | 67.45 beats per minute | Standard Error 1.96 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Heart Rate | 5 minutes before smoking | 60.94 beats per minute | Standard Error 1.79 |
| Active MJ With 200 mg CBD | Heart Rate | 150 minutes after smoking | 71.39 beats per minute | Standard Error 2.18 |
| Active MJ With 200 mg CBD | Heart Rate | 15 minutes after smoking | 79.23 beats per minute | Standard Error 2.44 |
| Active MJ With 200 mg CBD | Heart Rate | 120 minutes before smoking | 69.58 beats per minute | Standard Error 2.39 |
| Active MJ With 200 mg CBD | Heart Rate | 120 minutes after smoking | 73.03 beats per minute | Standard Error 2.3 |
| Active MJ With 200 mg CBD | Heart Rate | 60 minutes before smoking | 68.23 beats per minute | Standard Error 2.22 |
| Active MJ With 200 mg CBD | Heart Rate | 5 minutes before smoking | 64.48 beats per minute | Standard Error 1.97 |
| Active MJ With 200 mg CBD | Heart Rate | 90 minutes after smoking | 69.13 beats per minute | Standard Error 2.19 |
| Active MJ With 200 mg CBD | Heart Rate | 60 minutes after smoking | 68.42 beats per minute | Standard Error 2.6 |
| Active MJ With 200 mg CBD | Heart Rate | 30 minutes before smoking | 66.84 beats per minute | Standard Error 2.37 |
| Active MJ With 200 mg CBD | Heart Rate | 30 minutes after smoking | 75.45 beats per minute | Standard Error 2.36 |
| Active MJ With 400 mg CBD | Heart Rate | 90 minutes after smoking | 66.16 beats per minute | Standard Error 2.1 |
| Active MJ With 400 mg CBD | Heart Rate | 15 minutes after smoking | 80.74 beats per minute | Standard Error 2.89 |
| Active MJ With 400 mg CBD | Heart Rate | 30 minutes after smoking | 73.03 beats per minute | Standard Error 2.38 |
| Active MJ With 400 mg CBD | Heart Rate | 30 minutes before smoking | 65.42 beats per minute | Standard Error 1.75 |
| Active MJ With 400 mg CBD | Heart Rate | 120 minutes after smoking | 72.90 beats per minute | Standard Error 2.36 |
| Active MJ With 400 mg CBD | Heart Rate | 150 minutes after smoking | 71.03 beats per minute | Standard Error 2.16 |
| Active MJ With 400 mg CBD | Heart Rate | 5 minutes before smoking | 64.55 beats per minute | Standard Error 1.82 |
| Active MJ With 400 mg CBD | Heart Rate | 60 minutes before smoking | 67.87 beats per minute | Standard Error 2.02 |
| Active MJ With 400 mg CBD | Heart Rate | 60 minutes after smoking | 67.94 beats per minute | Standard Error 2.15 |
| Active MJ With 400 mg CBD | Heart Rate | 120 minutes before smoking | 69.90 beats per minute | Standard Error 2.31 |
| Active MJ With 800 mg CBD | Heart Rate | 90 minutes after smoking | 68.87 beats per minute | Standard Error 2.01 |
| Active MJ With 800 mg CBD | Heart Rate | 120 minutes before smoking | 66.23 beats per minute | Standard Error 2.04 |
| Active MJ With 800 mg CBD | Heart Rate | 60 minutes before smoking | 67.06 beats per minute | Standard Error 2.1 |
| Active MJ With 800 mg CBD | Heart Rate | 30 minutes before smoking | 66.35 beats per minute | Standard Error 1.72 |
| Active MJ With 800 mg CBD | Heart Rate | 5 minutes before smoking | 65.06 beats per minute | Standard Error 2.12 |
| Active MJ With 800 mg CBD | Heart Rate | 15 minutes after smoking | 78.68 beats per minute | Standard Error 2.79 |
| Active MJ With 800 mg CBD | Heart Rate | 30 minutes after smoking | 75.90 beats per minute | Standard Error 2.89 |
| Active MJ With 800 mg CBD | Heart Rate | 60 minutes after smoking | 68.48 beats per minute | Standard Error 2.24 |
| Active MJ With 800 mg CBD | Heart Rate | 120 minutes after smoking | 70.29 beats per minute | Standard Error 2.06 |
| Active MJ With 800 mg CBD | Heart Rate | 150 minutes after smoking | 68.68 beats per minute | Standard Error 1.81 |
| Inactive MJ With 0 mg CBD | Heart Rate | 60 minutes before smoking | 64.97 beats per minute | Standard Error 1.78 |
| Inactive MJ With 0 mg CBD | Heart Rate | 90 minutes after smoking | 64.06 beats per minute | Standard Error 1.8 |
| Inactive MJ With 0 mg CBD | Heart Rate | 30 minutes before smoking | 64.90 beats per minute | Standard Error 1.62 |
| Inactive MJ With 0 mg CBD | Heart Rate | 15 minutes after smoking | 63.81 beats per minute | Standard Error 2.03 |
| Inactive MJ With 0 mg CBD | Heart Rate | 60 minutes after smoking | 60.03 beats per minute | Standard Error 1.72 |
| Inactive MJ With 0 mg CBD | Heart Rate | 120 minutes before smoking | 65.13 beats per minute | Standard Error 2.09 |
| Inactive MJ With 0 mg CBD | Heart Rate | 30 minutes after smoking | 61.35 beats per minute | Standard Error 1.77 |
| Inactive MJ With 0 mg CBD | Heart Rate | 120 minutes after smoking | 67.35 beats per minute | Standard Error 1.9 |
| Inactive MJ With 0 mg CBD | Heart Rate | 5 minutes before smoking | 62.55 beats per minute | Standard Error 1.67 |
| Inactive MJ With 0 mg CBD | Heart Rate | 150 minutes after smoking | 66.58 beats per minute | Standard Error 1.69 |
| Inactive MJ With 200 mg CBD | Heart Rate | 120 minutes after smoking | 69.68 beats per minute | Standard Error 2.26 |
| Inactive MJ With 200 mg CBD | Heart Rate | 90 minutes after smoking | 63.97 beats per minute | Standard Error 1.94 |
| Inactive MJ With 200 mg CBD | Heart Rate | 5 minutes before smoking | 65.58 beats per minute | Standard Error 1.74 |
| Inactive MJ With 200 mg CBD | Heart Rate | 30 minutes after smoking | 62.94 beats per minute | Standard Error 1.86 |
| Inactive MJ With 200 mg CBD | Heart Rate | 15 minutes after smoking | 64.16 beats per minute | Standard Error 1.87 |
| Inactive MJ With 200 mg CBD | Heart Rate | 150 minutes after smoking | 67.71 beats per minute | Standard Error 1.87 |
| Inactive MJ With 200 mg CBD | Heart Rate | 60 minutes after smoking | 62.03 beats per minute | Standard Error 1.77 |
| Inactive MJ With 200 mg CBD | Heart Rate | 60 minutes before smoking | 68.32 beats per minute | Standard Error 1.7 |
| Inactive MJ With 200 mg CBD | Heart Rate | 30 minutes before smoking | 67.42 beats per minute | Standard Error 1.78 |
| Inactive MJ With 200 mg CBD | Heart Rate | 120 minutes before smoking | 67.65 beats per minute | Standard Error 1.99 |
| Inactive MJ With 400 mg CBD | Heart Rate | 150 minutes after smoking | 66.50 beats per minute | Standard Error 2.3 |
| Inactive MJ With 400 mg CBD | Heart Rate | 30 minutes after smoking | 62.52 beats per minute | Standard Error 1.83 |
| Inactive MJ With 400 mg CBD | Heart Rate | 30 minutes before smoking | 67.55 beats per minute | Standard Error 1.77 |
| Inactive MJ With 400 mg CBD | Heart Rate | 90 minutes after smoking | 61.87 beats per minute | Standard Error 2.06 |
| Inactive MJ With 400 mg CBD | Heart Rate | 120 minutes before smoking | 65.68 beats per minute | Standard Error 2.15 |
| Inactive MJ With 400 mg CBD | Heart Rate | 120 minutes after smoking | 67.35 beats per minute | Standard Error 2.24 |
| Inactive MJ With 400 mg CBD | Heart Rate | 60 minutes before smoking | 65.55 beats per minute | Standard Error 1.98 |
| Inactive MJ With 400 mg CBD | Heart Rate | 5 minutes before smoking | 63.10 beats per minute | Standard Error 1.8 |
| Inactive MJ With 400 mg CBD | Heart Rate | 60 minutes after smoking | 61.29 beats per minute | Standard Error 1.65 |
| Inactive MJ With 400 mg CBD | Heart Rate | 15 minutes after smoking | 63.97 beats per minute | Standard Error 2.05 |
| Inactive MJ With 800 mg CBD | Heart Rate | 30 minutes before smoking | 66.74 beats per minute | Standard Error 2.22 |
| Inactive MJ With 800 mg CBD | Heart Rate | 15 minutes after smoking | 64.55 beats per minute | Standard Error 1.79 |
| Inactive MJ With 800 mg CBD | Heart Rate | 30 minutes after smoking | 64.13 beats per minute | Standard Error 1.72 |
| Inactive MJ With 800 mg CBD | Heart Rate | 60 minutes before smoking | 66.06 beats per minute | Standard Error 2.09 |
| Inactive MJ With 800 mg CBD | Heart Rate | 60 minutes after smoking | 63.06 beats per minute | Standard Error 1.89 |
| Inactive MJ With 800 mg CBD | Heart Rate | 120 minutes before smoking | 67.84 beats per minute | Standard Error 2.19 |
| Inactive MJ With 800 mg CBD | Heart Rate | 90 minutes after smoking | 65.81 beats per minute | Standard Error 1.94 |
| Inactive MJ With 800 mg CBD | Heart Rate | 120 minutes after smoking | 68.87 beats per minute | Standard Error 2.14 |
| Inactive MJ With 800 mg CBD | Heart Rate | 5 minutes before smoking | 65.00 beats per minute | Standard Error 1.98 |
| Inactive MJ With 800 mg CBD | Heart Rate | 150 minutes after smoking | 68.70 beats per minute | Standard Error 2.11 |
Other Pre-specified
Marijuana Rating Form - Like
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
Population: all study completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Like | 15 minutes after smoking | 55.32 units on a scale | Standard Error 5.51 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Like | 120 minutes after smoking | 41.29 units on a scale | Standard Error 6.61 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Like | 90 minutes after smoking | 49.58 units on a scale | Standard Error 6.53 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Like | 60 minutes after smoking | 52.55 units on a scale | Standard Error 6.78 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Like | 30 minutes after smoking | 57.10 units on a scale | Standard Error 5.66 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 57.77 units on a scale | Standard Error 4.95 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 51.68 units on a scale | Standard Error 5.45 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 46.00 units on a scale | Standard Error 5.77 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 57.90 units on a scale | Standard Error 4.92 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 65.87 units on a scale | Standard Error 5.17 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 58.77 units on a scale | Standard Error 5.84 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 42.55 units on a scale | Standard Error 6.62 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 61.42 units on a scale | Standard Error 4.92 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 47.84 units on a scale | Standard Error 6.5 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 53.03 units on a scale | Standard Error 6.08 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 53.26 units on a scale | Standard Error 6.07 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 46.81 units on a scale | Standard Error 6.38 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 61.94 units on a scale | Standard Error 5.27 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 60.58 units on a scale | Standard Error 5.51 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 50.13 units on a scale | Standard Error 5.93 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 14.37 units on a scale | Standard Error 4.91 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 25.65 units on a scale | Standard Error 5.31 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 20.16 units on a scale | Standard Error 5.37 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 15.97 units on a scale | Standard Error 5.12 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 14.84 units on a scale | Standard Error 4.86 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 21.32 units on a scale | Standard Error 5.65 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 18.52 units on a scale | Standard Error 5.57 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 24.58 units on a scale | Standard Error 5.71 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 25.03 units on a scale | Standard Error 6.05 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 16.81 units on a scale | Standard Error 5.21 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 16.03 units on a scale | Standard Error 5.21 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 22.81 units on a scale | Standard Error 5.38 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 17.97 units on a scale | Standard Error 4.68 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 14.00 units on a scale | Standard Error 5.42 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 15.06 units on a scale | Standard Error 4.7 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Like | 120 minutes after smoking | 16.48 units on a scale | Standard Error 5.37 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Like | 90 minutes after smoking | 17.42 units on a scale | Standard Error 5.41 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Like | 15 minutes after smoking | 22.48 units on a scale | Standard Error 4.96 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Like | 60 minutes after smoking | 23.52 units on a scale | Standard Error 5.66 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Like | 30 minutes after smoking | 18.17 units on a scale | Standard Error 4.38 |
Other Pre-specified
Marijuana Rating Form - Strength
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
Population: all study completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Strength | 15 minutes after smoking | 45.68 units on a scale | Standard Error 6.19 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Strength | 120 minutes after smoking | 18.68 units on a scale | Standard Error 4.39 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Strength | 90 minutes after smoking | 27.19 units on a scale | Standard Error 4.92 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Strength | 60 minutes after smoking | 45.84 units on a scale | Standard Error 5.77 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Marijuana Rating Form - Strength | 30 minutes after smoking | 55.65 units on a scale | Standard Error 5.3 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 55.03 units on a scale | Standard Error 4.39 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 34.97 units on a scale | Standard Error 5.05 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 22.87 units on a scale | Standard Error 4.8 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 44.68 units on a scale | Standard Error 4.61 |
| Active MJ With 200 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 58.03 units on a scale | Standard Error 4.87 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 48.67 units on a scale | Standard Error 5.47 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 19.42 units on a scale | Standard Error 4.52 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 51.48 units on a scale | Standard Error 5.01 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 28.45 units on a scale | Standard Error 5.64 |
| Active MJ With 400 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 39.71 units on a scale | Standard Error 5.56 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 45.42 units on a scale | Standard Error 5.18 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 28.45 units on a scale | Standard Error 5.81 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 51.87 units on a scale | Standard Error 4.99 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 57.61 units on a scale | Standard Error 4.75 |
| Active MJ With 800 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 32.52 units on a scale | Standard Error 6.11 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 9.03 units on a scale | Standard Error 3 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 20.32 units on a scale | Standard Error 4.4 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 14.42 units on a scale | Standard Error 3.9 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 7.03 units on a scale | Standard Error 2.51 |
| Inactive MJ With 0 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 7.55 units on a scale | Standard Error 3.29 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 13.06 units on a scale | Standard Error 3.8 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 11.19 units on a scale | Standard Error 3.68 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 18.94 units on a scale | Standard Error 3.91 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 20.83 units on a scale | Standard Error 4.87 |
| Inactive MJ With 200 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 8.35 units on a scale | Standard Error 2.89 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 6.39 units on a scale | Standard Error 2.58 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 18.52 units on a scale | Standard Error 4.52 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 11.77 units on a scale | Standard Error 2.8 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 4.65 units on a scale | Standard Error 2.59 |
| Inactive MJ With 400 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 6.48 units on a scale | Standard Error 2.81 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Strength | 120 minutes after smoking | 7.19 units on a scale | Standard Error 3.14 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Strength | 90 minutes after smoking | 7.94 units on a scale | Standard Error 3.19 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Strength | 15 minutes after smoking | 16.87 units on a scale | Standard Error 3.47 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Strength | 60 minutes after smoking | 11.65 units on a scale | Standard Error 3.5 |
| Inactive MJ With 800 mg CBD | Marijuana Rating Form - Strength | 30 minutes after smoking | 14.83 units on a scale | Standard Error 3.5 |
Other Pre-specified
Number of Optional Puffs of MJ Cigarette Taken
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
Population: Those who took additional puffs of MJ cigarette.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Number of Optional Puffs of MJ Cigarette Taken | 1.68 number of puffs taken per participant | Standard Error 0.26 |
| Active MJ With 200 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 1.71 number of puffs taken per participant | Standard Error 0.25 |
| Active MJ With 400 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 1.58 number of puffs taken per participant | Standard Error 0.26 |
| Active MJ With 800 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 1.55 number of puffs taken per participant | Standard Error 0.26 |
| Inactive MJ With 0 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 0.94 number of puffs taken per participant | Standard Error 0.25 |
| Inactive MJ With 200 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 1.00 number of puffs taken per participant | Standard Error 0.25 |
| Inactive MJ With 400 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 1.00 number of puffs taken per participant | Standard Error 0.25 |
| Inactive MJ With 800 mg CBD | Number of Optional Puffs of MJ Cigarette Taken | 0.97 number of puffs taken per participant | Standard Error 0.25 |
Other Pre-specified
Optional Additional Puffs of MJ Cigarette
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
Population: all study completers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Optional Additional Puffs of MJ Cigarette | 19 Participants |
| Active MJ With 200 mg CBD | Optional Additional Puffs of MJ Cigarette | 19 Participants |
| Active MJ With 400 mg CBD | Optional Additional Puffs of MJ Cigarette | 18 Participants |
| Active MJ With 800 mg CBD | Optional Additional Puffs of MJ Cigarette | 18 Participants |
| Inactive MJ With 0 mg CBD | Optional Additional Puffs of MJ Cigarette | 10 Participants |
| Inactive MJ With 200 mg CBD | Optional Additional Puffs of MJ Cigarette | 11 Participants |
| Inactive MJ With 400 mg CBD | Optional Additional Puffs of MJ Cigarette | 11 Participants |
| Inactive MJ With 800 mg CBD | Optional Additional Puffs of MJ Cigarette | 10 Participants |
Other Pre-specified
Plasma Concentration of CBD
Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.
Time frame: 6 hours
Population: 8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | 180 minutes after dosing | 77.95 ng/mL | Standard Error 25 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | baseline | 0 ng/mL | Standard Error 0 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | 60 minutes after dosing | 11.06 ng/mL | Standard Error 5.43 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | 120 minutes after dosing | 38.88 ng/mL | Standard Error 11.84 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | 240 minutes after dosing | 77.90 ng/mL | Standard Error 32.72 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | 300 minutes after dosing | 50.45 ng/mL | Standard Error 14.76 |
| Active Marijuana (MJ) With 0 mg Cannabidiol (CBD) | Plasma Concentration of CBD | 360 minutes after dosing | 64.04 ng/mL | Standard Error 23.01 |