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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active marijuana (MJ) with 0 mg CBD | Other | Active MJ cigarettes contain 5.30% THC |
|
| Active MJ with 200 mg CBD | Other | Active MJ cigarettes contain 5.30% THC |
|
| Active MJ with 400 mg CBD | Other | Active MJ cigarettes contain 5.30% THC |
|
| Active MJ with 800 mg CBD | Other | Active MJ cigarettes contain 5.30% THC |
|
| Inactive MJ with 0 mg CBD | Other | Inactive MJ cigarettes contain 0.01% THC |
|
| Inactive MJ with 200 mg CBD | Other | Inactive MJ cigarettes contain 0.01% THC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | two hours before and after marijuana cigarette smoking |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15 - 120 minutes after marijuana cigarette smoking |
| Marijuana Rating Form - Strength |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, M.D. | New York State Psychiatric Institute | Principal Investigator |
| Robert J Malcolm, M.D. | Medical University of South Carolina | Study Director |
| Sharon Walsh, Ph.D. | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct. | Lexington | Kentucky | 40513 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
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| Visit 2 |
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| Visit 3 |
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| Visit 4 |
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| Visit 5 |
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| Visit 6 |
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| Visit 7 |
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| Visit 8 |
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count - only those participants who completed all 8 visits (31)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | all 31 completers | Posted | Mean | Standard Error | units on a scale VAS 1-100 mm | two hours before and after marijuana cigarette smoking |
|
Adverse events reported within 72 hours of each cannabidiol administration
Cannabis strength was collapsed for each cannabidiol dose level
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active MJ With 0 mg CBD | 31 subjects were tested with 0 mg CBD and an active marijuana cigarette. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Upset | Gastrointestinal disorders | other | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney, PhD., Professor | Columbia University Medical Center | (646) 774-6153 | mh235@columbia.edu |
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| ID | Term |
|---|---|
| D008385 | Marijuana Smoking |
| ID | Term |
|---|---|
| D000074609 | Marijuana Use |
| D001519 | Behavior |
| D000073847 | Smoking, Non-Tobacco Products |
| D012907 | Smoking |
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| Inactive MJ with 400 mg CBD |
| Other |
Inactive MJ cigarettes contain 0.01% THC |
|
| Inactive MJ with 800 mg CBD | Other | Inactive MJ cigarettes contain 0.01% THC |
|
|
|
Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most
| 15 - 120 minutes after marijuana cigarette smoking |
| 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. | 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day |
| Number of Optional Puffs of MJ Cigarette Taken | Mean number of puffs taken by those participants who chose to take additional puffs. | 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day |
| Heart Rate | Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis. | 120 minutes before and 150 minutes after marijuana cigarette smoking |
| Plasma Concentration of CBD | Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD. | 6 hours |
| Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120 |
| New York |
| New York |
| 10032 |
| United States |
| Center for Drug and Alcohol Programs, Room 459 North, 67 President St. | Charleston | South Carolina | 29425 | United States |
|
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| cannabis use (number of days per week) | Mean | Standard Deviation | days per week |
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| cannabis cigarettes per day | Mean | Standard Deviation | cannabis cigarettes used per day |
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| tobacco cigarette smokers | Number | participants |
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| alcohol drinkers | Number | participants |
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| OG002 | Active MJ With 400 mg CBD | MJ cigarette with 5.3% THC content pretreated with 400 mg CBD |
| OG003 | Active MJ With 800 mg CBD | MJ cigarette with 5.3% THC content pretreated with 800 mg CBD |
| OG004 | Inactive MJ With 0 mg CBD | MJ cigarette with 0.01% THC content pretreated with 0 mg CBD |
| OG005 | Inactive MJ With 200 mg CBD | MJ cigarette with 0.01% THC content pretreated with 200 mg CBD |
| OG006 | Inactive MJ With 400 mg CBD | MJ cigarette with 0.01% THC content pretreated with 400 mg CBD |
| OG007 | Inactive MJ With 800 mg CBD | MJ cigarette with 0.01% THC content pretreated with 800 mg CBD |
|
|
| 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 | all study completers | Posted | Mean | Standard Error | units on a scale | 15 - 120 minutes after marijuana cigarette smoking |
|
|
|
| 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 | all study completers | Posted | Mean | Standard Error | units on a scale | 15 - 120 minutes after marijuana cigarette smoking |
|
|
|
| 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. | all study completers | Posted | Count of Participants | Participants | 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day |
|
|
|
| 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. | Those who took additional puffs of MJ cigarette. | Posted | Mean | Standard Error | number of puffs taken per participant | 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day |
|
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| Other Pre-specified | Heart Rate | Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis. | all study completers | Posted | Mean | Standard Error | beats per minute | 120 minutes before and 150 minutes after marijuana cigarette smoking |
|
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| 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. | 8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples. | Posted | Mean | Standard Error | ng/mL | 6 hours |
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| 0 |
| 50 |
| 0 |
| 50 |
| 5 |
| 50 |
| EG001 | Active MJ With 200 mg CBD | 31 subjects were tested with 200 mg CBD and an active marijuana cigarette. | 0 | 50 | 0 | 50 | 8 | 50 |
| EG002 | Active MJ With 400 mg CBD | 31 subjects were tested with 400 mg CBD and an active marijuana cigarette. | 0 | 50 | 0 | 50 | 4 | 50 |
| EG003 | Active MJ With 800 mg CBD | 31 subjects were tested with 800 mg CBD and an active MJ cigarette. | 0 | 50 | 0 | 50 | 3 | 50 |
| EG004 | Inactive MJ With 0 mg CBD | 31 subjects were tested with 0 mg CBD and an inactive MJ cigarette. | 0 | 50 | 0 | 50 | 2 | 50 |
| EG005 | Inactive MJ With 200 mg CBD | 31 subjects were tested with 0 mg CBD and an inactive MJ cigarette. | 0 | 50 | 0 | 50 | 1 | 50 |
| EG006 | Inactive MJ With 400 mg CBD | 31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette. | 0 | 50 | 0 | 50 | 3 | 50 |
| EG007 | Inactive MJ With 800 mg CBD | 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. | 0 | 50 | 0 | 50 | 6 | 50 |
| headache | Nervous system disorders | other | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | other | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | other | Non-systematic Assessment |
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| fatigue | General disorders | other | Non-systematic Assessment |
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| Cold Symptoms | Infections and infestations | other | Non-systematic Assessment |
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| Pain (foot/hand/tooth) | Musculoskeletal and connective tissue disorders | other | Non-systematic Assessment |
|
| Increased heart rate | Cardiac disorders | other | Non-systematic Assessment |
|
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| 30 minutes after smoking |
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| 60 minutes after smoking |
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| 90 minutes after smoking |
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| 120 minutes after smoking |
|
| 30 minutes after smoking |
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| 60 minutes after smoking |
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| 90 minutes after smoking |
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| 120 minutes after smoking |
|
| 60 minutes before smoking |
|
| 30 minutes before smoking |
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| 5 minutes before smoking |
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| 15 minutes after smoking |
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| 30 minutes after smoking |
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| 60 minutes after smoking |
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| 90 minutes after smoking |
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| 120 minutes after smoking |
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| 150 minutes after smoking |
|
| Title | Measurements |
|---|---|
|
| 180 minutes after dosing |
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| 240 minutes after dosing |
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| 300 minutes after dosing |
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| 360 minutes after dosing |
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