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The main objectives of this study were to test if 2 different doses of Cannabidiol (compared to placebo) alter 1) breath alcohol concentration, 2) craving and subjective responses to alcohol or 3) cognitive performance following a standard dose of alcohol.
Cannabidiol (CBD), is commonly found in the cannabis plant and has shown promise in treating alcohol use disorders (AUD). In this within-subjects, placebo-controlled, crossover study, the investigators explored the effects of two doses (200mg and 30mg) of plant-based CBD (compared to placebo CBD) on blood alcohol level, subjective effects of alcohol, craving and cognition over the course 4 hours after subjects consume a standardized dose of alcohol.
This pilot study was conducted at Colorado State University and volunteers were recruited from the local community. 36 individuals completed at least 1 study session and 22 completed all three sessions. At each session they received either placebo 30mg oral CBD or 200mg oral CBD prior to being given a standard dose of alcohol. They then remained in our laboratory for 4 hours and completed cognitive testing using the NIH toolbox Cognitive Battery, breath alcohol level measurements and self-reported intoxication ratings (using the The Biphasic Alcohol Effects Scale [BAES] and the The Subjective Effects of Alcohol Scale [SEAS]) and reported their craving levels using the Alcohol Urge Questionnaire (AUQ) every 30 minutes. They also provided 3 blood samples to measure blood-CBD levels at each session (prior to receiving the CBD, 25 minutes post-CBD ingestion and again 60 minutes later). Study sessions were separated by at least one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200mg Cannabidiol | Experimental | - A single dose of 200mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water). |
|
| 30mg Cannabidiol, | Experimental | - A single dose of 30mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water). |
|
| Placebo | Placebo Comparator | - A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 200mg Cannabidiol oral solution | Dietary Supplement | 200mg cannabidiol administered in the laboratory prior to a standard dose of alcohol. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| Measure | Description | Time Frame |
|---|---|---|
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 1 (20 minutes after alcohol consumption is complete) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 2 (30 minutes after Timepoint 1) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 3 (30 minutes after Timepoint 2) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 4 (30 minutes after Timepoint 3) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 5 (30 minutes after Timepoint 4) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 6 (30 minutes after Timepoint 6) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University | Fort Collins | Colorado | 80523 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36939855 | Result | Karoly HC, Drennan ML, Prince MA, Zulic L, Dooley G. Consuming oral cannabidiol prior to a standard alcohol dose has minimal effect on breath alcohol level and subjective effects of alcohol. Psychopharmacology (Berl). 2023 May;240(5):1119-1129. doi: 10.1007/s00213-023-06349-z. Epub 2023 Mar 20. |
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Individual (de-identified) participant data is to be made available to other researchers.
Data will become available upon request.
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This is a crossover design. The total number of people enrolled was N=37. Of those 37, 1 was dropped from the study before completing any sessions, n=22 completed all three arms, n=4 completed only 2 appointments, and n=10 completed only 1 appointment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 200mg Cannabidiol, 30mg Cannabidiol, Placebo | Experimental, 200mg CBD, 30mg CBD, Placebo Participants first received a single dose of 200mg CBD commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 30mg the same commercially available CBD product supplied by Caliper Foods, to be consumed orally (mixed with water) and administered in the laboratory. After a washout period of 7 days, they received a Placebo supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| FG001 | 200mg Cannabidiol, Placebo, 30mg Cannabidiol | Experimental, 200mg CBD, Placebo, 30mg CBD Participants first received a single dose of 200mg CBD commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a Placebo supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 30mg the same commercially available CBD product supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| FG002 | 30mg Cannabidiol, Placebo, 200mg Cannabidiol | Experimental: 30mg CBD, Placebo, 200mg CBD Participants first received a single dose of 30mg CBD commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a Placebo supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 200mg of the same commercially available CBD product supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| FG003 | 30mg Cannabidiol, 200mg Cannabidiol, Placebo | Experimental: 30mg CBD, 200mg CBD, Placebo, Participants first received a single dose of 30mg CBD commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 200mg of the same commercially available CBD product supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a Placebo supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| FG004 | Placebo, 200mg Cannabidiol, 30mg Cannabidiol | Experimental: Placebo, 200mg CBD, 30mg CBD Participants first received a single dose of Placebo supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 200mg CBD commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 30mg of the same commercially available CBD product supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| FG005 | Placebo, 30mg Cannabidiol, 200mg Cannabidiol | Experimental: Placebo, 30mg CBD, 200mg CBD Participants first received a single dose of Placebo supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 30mg CBD commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. After a washout period of 7 days, they received a single dose of 200mg of the same commercially available CBD product supplied by Caliper Foods, to be consumed orally (mixed with water), and administered in the laboratory. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 36 individuals who participated in the study (i.e., who completed at least one study session) were included in baseline descriptive analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Sample | Individuals (N=36) who completed at least 1 session |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 1 (20 minutes after alcohol consumption is complete) |
|
Participants were assessed during each study visit in related to baseline (for up to three study visits per participant), with each visit lasting 5 hours.
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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 | 200mg Cannabidiol | - A single dose of 200mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water). 200mg Cannabidiol oral solution: 200mg cannabidiol administered in the laboratory prior to a standard dose of alcohol. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hollis Karoly | Colorado State University | 970-491-3677 | hollis.karoly@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2021 | Nov 29, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2021 | Nov 26, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| 30mg Cannabidiol oral solution | Dietary Supplement | 30mg cannabidiol administered in the laboratory prior to a standard dose of alcohol. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
|
| Placebo | Dietary Supplement | Placebo administered in the laboratory prior to a standard dose of alcohol. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. |
|
| Timepoint 7 (30 minutes after Timepoint 6) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 8 (30 minutes after Timepoint 9) |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Timepoint 9 (30 minutes after Timepoint 8) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 1 (20 minutes after alcohol consumption is complete) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 2 (30 minutes after Timepoint 1) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 3 (30 minutes after Timepoint 2) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 4 (30 minutes after Timepoint 3) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 5 (30 minutes after Timepoint 4) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 6 (30 minutes after Timepoint 5) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 7 (30 minutes after Timepoint 6) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 8 (30 minutes after Timepoint 7) |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Timepoint 9 (30 minutes after Timepoint 8) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 1 (20 minutes after alcohol consumption is complete) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 2 (30 minutes after Timepoint 1) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 3 (30 minutes after Timepoint 2) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 4 (30 minutes after Timepoint 3) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 5 (30 minutes after Timepoint 4) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 6 (30 minutes after Timepoint 5) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 7 (30 minutes after Timepoint 6) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 8 (30 minutes after Timepoint 7) |
| Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Timepoint 9 (30 minutes after Timepoint 8) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 1 (20 minutes after alcohol consumption is complete) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 2 (30 minutes after Timepoint 1) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 3 (30 minutes after Timepoint 4) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 4 (30 minutes after Timepoint 3) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 5 (30 minutes after Timepoint 4) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 6 (30 minutes after Timepoint 5) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 7 (30 minutes after Timepoint 6) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 8 (30 minutes after Timepoint 7) |
| Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Timepoint 9 (30 minutes after Timepoint 8) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol Use Disorders Identification Test | Alcohol Use Disorders Identification Test, which measures the severity of alcohol use problems and indicates the likelihood that someone is experiencing hazardous alcohol use. Total score ranges from 0-40 (where higher values represent more problems with alcohol and a higher likelihood of hazardous alcohol use) | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory | Beck Depression Inventory, which measures current depression symptoms. The range of possible total scores is 0 to 63, where higher scores indicate more severe depression. | Mean | Standard Deviation | units on a scale |
|
| Beck Anxiety Inventory | Beck anxiety inventory, which measures current anxiety symptoms. Total score ranges from 0 to 63, with higher scores indicating greater severity of anxiety. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 30mg Cannabidiol, | - A single dose of 30mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water). 30mg Cannabidiol oral solution: 30mg cannabidiol administered in the laboratory prior to a standard dose of alcohol. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). |
| OG002 | Placebo | - A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water). Placebo: Placebo administered in the laboratory prior to a standard dose of alcohol. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. |
|
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 2 (30 minutes after Timepoint 1) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 3 (30 minutes after Timepoint 2) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 4 (30 minutes after Timepoint 3) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 5 (30 minutes after Timepoint 4) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 6 (30 minutes after Timepoint 6) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 7 (30 minutes after Timepoint 6) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Mean | Standard Deviation | g/dL | Timepoint 8 (30 minutes after Timepoint 9) |
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| Primary | Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | Posted | Median | Standard Deviation | g/dL | Timepoint 9 (30 minutes after Timepoint 8) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 1 (20 minutes after alcohol consumption is complete) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 2 (30 minutes after Timepoint 1) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 3 (30 minutes after Timepoint 2) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 4 (30 minutes after Timepoint 3) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 5 (30 minutes after Timepoint 4) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 6 (30 minutes after Timepoint 5) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 7 (30 minutes after Timepoint 6) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 8 (30 minutes after Timepoint 7) |
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| Primary | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated. | Posted | Mean | Standard Deviation | score on a scale | Timepoint 9 (30 minutes after Timepoint 8) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 1 (20 minutes after alcohol consumption is complete) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 2 (30 minutes after Timepoint 1) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 3 (30 minutes after Timepoint 2) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 4 (30 minutes after Timepoint 3) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 5 (30 minutes after Timepoint 4) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 6 (30 minutes after Timepoint 5) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 7 (30 minutes after Timepoint 6) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 8 (30 minutes after Timepoint 7) |
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| Primary | Biphasic Effects of Alcohol--Sedation Subscale | BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated | Posted | Mean | Standard Deviation | score on a scale | Timepoint 9 (30 minutes after Timepoint 8) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 1 (20 minutes after alcohol consumption is complete) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 2 (30 minutes after Timepoint 1) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 3 (30 minutes after Timepoint 4) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 4 (30 minutes after Timepoint 3) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 5 (30 minutes after Timepoint 4) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 6 (30 minutes after Timepoint 5) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 7 (30 minutes after Timepoint 6) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 8 (30 minutes after Timepoint 7) |
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| Primary | Alcohol Urge Questionnaire (AUQ | The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse | Posted | Mean | Standard Deviation | score on a scale | Timepoint 9 (30 minutes after Timepoint 8) |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 30mg Cannabidiol, | - A single dose of 30mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water). 30mg Cannabidiol oral solution: 30mg cannabidiol administered in the laboratory prior to a standard dose of alcohol. The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment). | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Placebo | - A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water). Placebo: Placebo administered in the laboratory prior to a standard dose of alcohol. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%. | 0 | 27 | 0 | 27 | 0 | 27 |
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