Trial Outcomes & Findings for Cannabidiol Effects on Blood Alcohol Level and Intoxication (NCT NCT06105138)
NCT ID: NCT06105138
Last Updated: 2024-10-23
Results Overview
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Timepoint 1 (20 minutes after alcohol consumption is complete)
Results posted on
2024-10-23
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
4
|
7
|
12
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
0
|
5
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
2
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cannabidiol Effects on Blood Alcohol Level and Intoxication
Baseline characteristics by cohort
| Measure |
Entire Sample
n=36 Participants
Individuals (N=36) who completed at least 1 session
|
|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 6.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
34 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
|
Alcohol Use Disorders Identification Test
|
9.7 units on a scale
STANDARD_DEVIATION 4.7 • n=93 Participants
|
|
Beck Depression Inventory
|
7.3 units on a scale
STANDARD_DEVIATION 6.3 • n=93 Participants
|
|
Beck Anxiety Inventory
|
4.4 units on a scale
STANDARD_DEVIATION 5.8 • n=93 Participants
|
PRIMARY outcome
Timeframe: Timepoint 1 (20 minutes after alcohol consumption is complete)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
0.065 g/dL
Standard Deviation 0.017
|
.067 g/dL
Standard Deviation .015
|
.070 g/dL
Standard Deviation .014
|
PRIMARY outcome
Timeframe: Timepoint 2 (30 minutes after Timepoint 1)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
0.066 g/dL
Standard Deviation 0.014
|
0.067 g/dL
Standard Deviation 0.013
|
0.069 g/dL
Standard Deviation 0.011
|
PRIMARY outcome
Timeframe: Timepoint 3 (30 minutes after Timepoint 2)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
0.059 g/dL
Standard Deviation 0.011
|
0.058 g/dL
Standard Deviation 0.010
|
0.061 g/dL
Standard Deviation 0.008
|
PRIMARY outcome
Timeframe: Timepoint 4 (30 minutes after Timepoint 3)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
0.048 g/dL
Standard Deviation 0.010
|
0.049 g/dL
Standard Deviation 0.009
|
0.050 g/dL
Standard Deviation 0.008
|
PRIMARY outcome
Timeframe: Timepoint 5 (30 minutes after Timepoint 4)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
.040 g/dL
Standard Deviation .009
|
.040 g/dL
Standard Deviation .009
|
.041 g/dL
Standard Deviation .007
|
PRIMARY outcome
Timeframe: Timepoint 6 (30 minutes after Timepoint 6)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
0.032 g/dL
Standard Deviation .009
|
.032 g/dL
Standard Deviation .010
|
.034 g/dL
Standard Deviation .007
|
PRIMARY outcome
Timeframe: Timepoint 7 (30 minutes after Timepoint 6)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
.023 g/dL
Standard Deviation .010
|
.024 g/dL
Standard Deviation .011
|
.027 g/dL
Standard Deviation .008
|
PRIMARY outcome
Timeframe: Timepoint 8 (30 minutes after Timepoint 9)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
.016 g/dL
Standard Deviation .011
|
.018 g/dL
Standard Deviation .011
|
.020 g/dL
Standard Deviation .008
|
PRIMARY outcome
Timeframe: Timepoint 9 (30 minutes after Timepoint 8)Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Outcome measures
| Measure |
200mg Cannabidiol
n=28 Participants
\- 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).
|
30mg Cannabidiol,
n=26 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Breath Alcohol Concentration (BrAC)
|
.013 g/dL
Standard Deviation .012
|
.012 g/dL
Standard Deviation .011
|
.013 g/dL
Standard Deviation .009
|
PRIMARY outcome
Timeframe: Timepoint 1 (20 minutes after alcohol consumption is complete)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
9.40 score on a scale
Standard Deviation 15.47
|
13.64 score on a scale
Standard Deviation 20.01
|
14.07 score on a scale
Standard Deviation 18.15
|
PRIMARY outcome
Timeframe: Timepoint 2 (30 minutes after Timepoint 1)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=26 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
26.17 score on a scale
Standard Deviation 17.54
|
27.82 score on a scale
Standard Deviation 16.20
|
25.74 score on a scale
Standard Deviation 16.27
|
PRIMARY outcome
Timeframe: Timepoint 3 (30 minutes after Timepoint 2)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
19.66 score on a scale
Standard Deviation 15.24
|
21.39 score on a scale
Standard Deviation 14.56
|
18.78 score on a scale
Standard Deviation 15.01
|
PRIMARY outcome
Timeframe: Timepoint 4 (30 minutes after Timepoint 3)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
15.10 score on a scale
Standard Deviation 14.33
|
14.14 score on a scale
Standard Deviation 12.25
|
15.78 score on a scale
Standard Deviation 14.73
|
PRIMARY outcome
Timeframe: Timepoint 5 (30 minutes after Timepoint 4)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
11.07 score on a scale
Standard Deviation 12.18
|
11.96 score on a scale
Standard Deviation 11.17
|
11.56 score on a scale
Standard Deviation 13.00
|
PRIMARY outcome
Timeframe: Timepoint 6 (30 minutes after Timepoint 5)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
9.07 score on a scale
Standard Deviation 9.86
|
8.18 score on a scale
Standard Deviation 9.85
|
8.81 score on a scale
Standard Deviation 11.94
|
PRIMARY outcome
Timeframe: Timepoint 7 (30 minutes after Timepoint 6)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
6.86 score on a scale
Standard Deviation 9.60
|
6.68 score on a scale
Standard Deviation 10.22
|
8.33 score on a scale
Standard Deviation 12.04
|
PRIMARY outcome
Timeframe: Timepoint 8 (30 minutes after Timepoint 7)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
5.44 score on a scale
Standard Deviation 8.27
|
5.81 score on a scale
Standard Deviation 7.66
|
5.93 score on a scale
Standard Deviation 8.53
|
PRIMARY outcome
Timeframe: Timepoint 9 (30 minutes after Timepoint 8)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.
Outcome measures
| Measure |
200mg Cannabidiol
n=28 Participants
\- 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).
|
30mg Cannabidiol,
n=27 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
|
4.96 score on a scale
Standard Deviation 7.63
|
4.89 score on a scale
Standard Deviation 7.55
|
6.78 score on a scale
Standard Deviation 8.31
|
PRIMARY outcome
Timeframe: Timepoint 1 (20 minutes after alcohol consumption is complete)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
2.66 score on a scale
Standard Deviation 5.18
|
4.18 score on a scale
Standard Deviation 6.06
|
3.78 score on a scale
Standard Deviation 5.21
|
PRIMARY outcome
Timeframe: Timepoint 2 (30 minutes after Timepoint 1)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
12.31 score on a scale
Standard Deviation 10.04
|
13.75 score on a scale
Standard Deviation 10.66
|
11.81 score on a scale
Standard Deviation 10.01
|
PRIMARY outcome
Timeframe: Timepoint 3 (30 minutes after Timepoint 2)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
15.45 score on a scale
Standard Deviation 12.40
|
14.07 score on a scale
Standard Deviation 11.31
|
13.41 score on a scale
Standard Deviation 12.01
|
PRIMARY outcome
Timeframe: Timepoint 4 (30 minutes after Timepoint 3)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
15.76 score on a scale
Standard Deviation 13.91
|
17.86 score on a scale
Standard Deviation 14.41
|
14.15 score on a scale
Standard Deviation 13.96
|
PRIMARY outcome
Timeframe: Timepoint 5 (30 minutes after Timepoint 4)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
15.41 score on a scale
Standard Deviation 14.53
|
13.29 score on a scale
Standard Deviation 12.36
|
12.89 score on a scale
Standard Deviation 13.86
|
PRIMARY outcome
Timeframe: Timepoint 6 (30 minutes after Timepoint 5)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
14.86 score on a scale
Standard Deviation 15.01
|
12.11 score on a scale
Standard Deviation 13.14
|
12.00 score on a scale
Standard Deviation 14.05
|
PRIMARY outcome
Timeframe: Timepoint 7 (30 minutes after Timepoint 6)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
11.72 score on a scale
Standard Deviation 14.69
|
9.96 score on a scale
Standard Deviation 11.30
|
10.48 score on a scale
Standard Deviation 12.19
|
PRIMARY outcome
Timeframe: Timepoint 8 (30 minutes after Timepoint 7)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
8.31 score on a scale
Standard Deviation 12.31
|
9.22 score on a scale
Standard Deviation 10.78
|
8.74 score on a scale
Standard Deviation 10.85
|
PRIMARY outcome
Timeframe: Timepoint 9 (30 minutes after Timepoint 8)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
Outcome measures
| Measure |
200mg Cannabidiol
n=28 Participants
\- 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).
|
30mg Cannabidiol,
n=27 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Biphasic Effects of Alcohol--Sedation Subscale
|
8.07 score on a scale
Standard Deviation 10.86
|
6.70 score on a scale
Standard Deviation 8.09
|
6.89 score on a scale
Standard Deviation 7.90
|
PRIMARY outcome
Timeframe: Timepoint 1 (20 minutes after alcohol consumption is complete)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
19.0 score on a scale
Standard Deviation 7.95
|
19.82 score on a scale
Standard Deviation 7.79
|
18.26 score on a scale
Standard Deviation 8.19
|
PRIMARY outcome
Timeframe: Timepoint 2 (30 minutes after Timepoint 1)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
22.76 score on a scale
Standard Deviation 10.52
|
23.14 score on a scale
Standard Deviation 11.26
|
23.96 score on a scale
Standard Deviation 10.51
|
PRIMARY outcome
Timeframe: Timepoint 3 (30 minutes after Timepoint 4)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
21.79 score on a scale
Standard Deviation 9.42
|
21.25 score on a scale
Standard Deviation 10.08
|
221.93 score on a scale
Standard Deviation 10.08
|
PRIMARY outcome
Timeframe: Timepoint 4 (30 minutes after Timepoint 3)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
19.93 score on a scale
Standard Deviation 8.38
|
19.21 score on a scale
Standard Deviation 9.55
|
19.56 score on a scale
Standard Deviation 8.73
|
PRIMARY outcome
Timeframe: Timepoint 5 (30 minutes after Timepoint 4)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
19.03 score on a scale
Standard Deviation 7.76
|
18.46 score on a scale
Standard Deviation 9.08
|
18.67 score on a scale
Standard Deviation 8.50
|
PRIMARY outcome
Timeframe: Timepoint 6 (30 minutes after Timepoint 5)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
18.59 score on a scale
Standard Deviation 8.67
|
19.21 score on a scale
Standard Deviation 10.58
|
17.19 score on a scale
Standard Deviation 7.77
|
PRIMARY outcome
Timeframe: Timepoint 7 (30 minutes after Timepoint 6)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
17.79 score on a scale
Standard Deviation 7.89
|
17.54 score on a scale
Standard Deviation 9.49
|
16.85 score on a scale
Standard Deviation 7.61
|
PRIMARY outcome
Timeframe: Timepoint 8 (30 minutes after Timepoint 7)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
Outcome measures
| Measure |
200mg Cannabidiol
n=29 Participants
\- 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).
|
30mg Cannabidiol,
n=28 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
16.83 score on a scale
Standard Deviation 8.21
|
17.67 score on a scale
Standard Deviation 10.51
|
16.11 score on a scale
Standard Deviation 7.98
|
PRIMARY outcome
Timeframe: Timepoint 9 (30 minutes after Timepoint 8)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
Outcome measures
| Measure |
200mg Cannabidiol
n=28 Participants
\- 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).
|
30mg Cannabidiol,
n=27 Participants
\- 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).
|
Placebo
n=27 Participants
\- 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%.
|
|---|---|---|---|
|
Alcohol Urge Questionnaire (AUQ
|
17.04 score on a scale
Standard Deviation 8.10
|
17.41 score on a scale
Standard Deviation 9.78
|
15.59 score on a scale
Standard Deviation 7.78
|
Adverse Events
200mg Cannabidiol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30mg Cannabidiol,
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place