Alcohol Use Disorder
Conditions
Keywords
alcohol, cannabidiol, craving
Brief summary
The main objectives of this study were to test if 2 different doses of Cannabidiol (compared to placebo) alter 1) breath alcohol concentration, 2) craving and subjective responses to alcohol or 3) cognitive performance following a standard dose of alcohol.
Detailed description
Cannabidiol (CBD), is commonly found in the cannabis plant and has shown promise in treating alcohol use disorders (AUD). In this within-subjects, placebo-controlled, crossover study, the investigators explored the effects of two doses (200mg and 30mg) of plant-based CBD (compared to placebo CBD) on blood alcohol level, subjective effects of alcohol, craving and cognition over the course 4 hours after subjects consume a standardized dose of alcohol. This pilot study was conducted at Colorado State University and volunteers were recruited from the local community. 36 individuals completed at least 1 study session and 22 completed all three sessions. At each session they received either placebo 30mg oral CBD or 200mg oral CBD prior to being given a standard dose of alcohol. They then remained in our laboratory for 4 hours and completed cognitive testing using the NIH toolbox Cognitive Battery, breath alcohol level measurements and self-reported intoxication ratings (using the The Biphasic Alcohol Effects Scale \[BAES\] and the The Subjective Effects of Alcohol Scale \[SEAS\]) and reported their craving levels using the Alcohol Urge Questionnaire (AUQ) every 30 minutes. They also provided 3 blood samples to measure blood-CBD levels at each session (prior to receiving the CBD, 25 minutes post-CBD ingestion and again 60 minutes later). Study sessions were separated by at least one week.
Interventions
DIETARY_SUPPLEMENT200mg 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).
DIETARY_SUPPLEMENT30mg 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).
DIETARY_SUPPLEMENTPlacebo
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%.
Sponsors
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 21-60 years old * able to provide consent * willing to consume CBD during the study * report heavy drinking (\>5 drinks \[\>4 for women\] per occasion on at least 5 days/month in the past 3 months) * not cannabis/CBD naive (i.e. THC or CBD use at least once in the past year), do not use cannabis regularly (i.e., less than monthly over past year), and no past-month cannabis use.
Exclusion criteria
* a regular or recent cannabis user (i.e. they used cannabis more often than monthly during the past year or used cannabis in the past month) * were seeking treatment a substance use disorder (SUD) including AUD, taking medications to treat bipolar or psychotic disorders * using nicotine every day * taking blood thinning medications * reported having a major medical condition contraindicating alcohol or CBD use (e.g., liver disease or heart disease) * reported current suicidality * met criteria for psychotic disorder, bipolar disorder or a current major depressive episode, * reported using illicit drugs in the 30 days prior to beginning the study or tested positive for any illicit drugs * were pregnant, breastfeeding or trying to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath Alcohol Concentration (BrAC) | Timepoint 1 (20 minutes after alcohol consumption is complete) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session |
| Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 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. |
| Biphasic Effects of Alcohol--Sedation Subscale | 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 |
| Alcohol Urge Questionnaire (AUQ | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Entire Sample Individuals (N=36) who completed at least 1 session | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Entire Sample |
|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 6.8 |
| Alcohol Use Disorders Identification Test | 9.7 units on a scale STANDARD_DEVIATION 4.7 |
| Beck Anxiety Inventory | 4.4 units on a scale STANDARD_DEVIATION 5.8 |
| Beck Depression Inventory | 7.3 units on a scale STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Mixed Race | 1 participants |
| Race/Ethnicity, Customized White | 34 participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 | 0 / 27 |
| other Total, other adverse events | 0 / 29 | 0 / 28 | 0 / 27 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 | 0 / 27 |
Outcome results
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 19.0 score on a scale | Standard Deviation 7.95 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 19.82 score on a scale | Standard Deviation 7.79 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 18.26 score on a scale | Standard Deviation 8.19 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 9 (30 minutes after Timepoint 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 17.04 score on a scale | Standard Deviation 8.1 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 17.41 score on a scale | Standard Deviation 9.78 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 15.59 score on a scale | Standard Deviation 7.78 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 8 (30 minutes after Timepoint 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 16.83 score on a scale | Standard Deviation 8.21 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 17.67 score on a scale | Standard Deviation 10.51 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 16.11 score on a scale | Standard Deviation 7.98 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 17.79 score on a scale | Standard Deviation 7.89 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 17.54 score on a scale | Standard Deviation 9.49 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 16.85 score on a scale | Standard Deviation 7.61 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 6 (30 minutes after Timepoint 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 18.59 score on a scale | Standard Deviation 8.67 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 19.21 score on a scale | Standard Deviation 10.58 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 17.19 score on a scale | Standard Deviation 7.77 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 19.03 score on a scale | Standard Deviation 7.76 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 18.46 score on a scale | Standard Deviation 9.08 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 18.67 score on a scale | Standard Deviation 8.5 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 19.93 score on a scale | Standard Deviation 8.38 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 19.21 score on a scale | Standard Deviation 9.55 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 19.56 score on a scale | Standard Deviation 8.73 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 3 (30 minutes after Timepoint 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 21.79 score on a scale | Standard Deviation 9.42 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 21.25 score on a scale | Standard Deviation 10.08 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 221.93 score on a scale | Standard Deviation 10.08 |
Primary
Alcohol Urge Questionnaire (AUQ
The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Alcohol Urge Questionnaire (AUQ | 22.76 score on a scale | Standard Deviation 10.52 |
| 30mg Cannabidiol, | Alcohol Urge Questionnaire (AUQ | 23.14 score on a scale | Standard Deviation 11.26 |
| Placebo | Alcohol Urge Questionnaire (AUQ | 23.96 score on a scale | Standard Deviation 10.51 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 9.40 score on a scale | Standard Deviation 15.47 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 13.64 score on a scale | Standard Deviation 20.01 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 14.07 score on a scale | Standard Deviation 18.15 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 26.17 score on a scale | Standard Deviation 17.54 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 27.82 score on a scale | Standard Deviation 16.2 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 25.74 score on a scale | Standard Deviation 16.27 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 3 (30 minutes after Timepoint 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 19.66 score on a scale | Standard Deviation 15.24 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 21.39 score on a scale | Standard Deviation 14.56 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 18.78 score on a scale | Standard Deviation 15.01 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 15.10 score on a scale | Standard Deviation 14.33 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 14.14 score on a scale | Standard Deviation 12.25 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 15.78 score on a scale | Standard Deviation 14.73 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 11.07 score on a scale | Standard Deviation 12.18 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 11.96 score on a scale | Standard Deviation 11.17 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 11.56 score on a scale | Standard Deviation 13 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 6 (30 minutes after Timepoint 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 9.07 score on a scale | Standard Deviation 9.86 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 8.18 score on a scale | Standard Deviation 9.85 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 8.81 score on a scale | Standard Deviation 11.94 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 6.86 score on a scale | Standard Deviation 9.6 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 6.68 score on a scale | Standard Deviation 10.22 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 8.33 score on a scale | Standard Deviation 12.04 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 8 (30 minutes after Timepoint 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 5.44 score on a scale | Standard Deviation 8.27 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 5.81 score on a scale | Standard Deviation 7.66 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 5.93 score on a scale | Standard Deviation 8.53 |
Primary
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.
Time frame: Timepoint 9 (30 minutes after Timepoint 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 4.96 score on a scale | Standard Deviation 7.63 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 4.89 score on a scale | Standard Deviation 7.55 |
| Placebo | Biphasic Effects of Alcohol (BAES)--Stimulation Subscale | 6.78 score on a scale | Standard Deviation 8.31 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 2.66 score on a scale | Standard Deviation 5.18 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 4.18 score on a scale | Standard Deviation 6.06 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 3.78 score on a scale | Standard Deviation 5.21 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 12.31 score on a scale | Standard Deviation 10.04 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 13.75 score on a scale | Standard Deviation 10.66 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 11.81 score on a scale | Standard Deviation 10.01 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 3 (30 minutes after Timepoint 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 15.45 score on a scale | Standard Deviation 12.4 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 14.07 score on a scale | Standard Deviation 11.31 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 13.41 score on a scale | Standard Deviation 12.01 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 15.76 score on a scale | Standard Deviation 13.91 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 17.86 score on a scale | Standard Deviation 14.41 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 14.15 score on a scale | Standard Deviation 13.96 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 15.41 score on a scale | Standard Deviation 14.53 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 13.29 score on a scale | Standard Deviation 12.36 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 12.89 score on a scale | Standard Deviation 13.86 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 6 (30 minutes after Timepoint 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 14.86 score on a scale | Standard Deviation 15.01 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 12.11 score on a scale | Standard Deviation 13.14 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 12.00 score on a scale | Standard Deviation 14.05 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 11.72 score on a scale | Standard Deviation 14.69 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 9.96 score on a scale | Standard Deviation 11.3 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 10.48 score on a scale | Standard Deviation 12.19 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 8 (30 minutes after Timepoint 7)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 8.31 score on a scale | Standard Deviation 12.31 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 9.22 score on a scale | Standard Deviation 10.78 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 8.74 score on a scale | Standard Deviation 10.85 |
Primary
Biphasic Effects of Alcohol--Sedation Subscale
BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated
Time frame: Timepoint 9 (30 minutes after Timepoint 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Biphasic Effects of Alcohol--Sedation Subscale | 8.07 score on a scale | Standard Deviation 10.86 |
| 30mg Cannabidiol, | Biphasic Effects of Alcohol--Sedation Subscale | 6.70 score on a scale | Standard Deviation 8.09 |
| Placebo | Biphasic Effects of Alcohol--Sedation Subscale | 6.89 score on a scale | Standard Deviation 7.9 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | 0.065 g/dL | Standard Deviation 0.017 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | .067 g/dL | Standard Deviation 0.015 |
| Placebo | Breath Alcohol Concentration (BrAC) | .070 g/dL | Standard Deviation 0.014 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 8 (30 minutes after Timepoint 9)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | .016 g/dL | Standard Deviation 0.011 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | .018 g/dL | Standard Deviation 0.011 |
| Placebo | Breath Alcohol Concentration (BrAC) | .020 g/dL | Standard Deviation 0.008 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 9 (30 minutes after Timepoint 8)
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | .013 g/dL | Standard Deviation 0.012 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | .012 g/dL | Standard Deviation 0.011 |
| Placebo | Breath Alcohol Concentration (BrAC) | .013 g/dL | Standard Deviation 0.009 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | .023 g/dL | Standard Deviation 0.01 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | .024 g/dL | Standard Deviation 0.011 |
| Placebo | Breath Alcohol Concentration (BrAC) | .027 g/dL | Standard Deviation 0.008 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 6 (30 minutes after Timepoint 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | 0.032 g/dL | Standard Deviation 0.009 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | .032 g/dL | Standard Deviation 0.01 |
| Placebo | Breath Alcohol Concentration (BrAC) | .034 g/dL | Standard Deviation 0.007 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | .040 g/dL | Standard Deviation 0.009 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | .040 g/dL | Standard Deviation 0.009 |
| Placebo | Breath Alcohol Concentration (BrAC) | .041 g/dL | Standard Deviation 0.007 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | 0.048 g/dL | Standard Deviation 0.01 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | 0.049 g/dL | Standard Deviation 0.009 |
| Placebo | Breath Alcohol Concentration (BrAC) | 0.050 g/dL | Standard Deviation 0.008 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 3 (30 minutes after Timepoint 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | 0.059 g/dL | Standard Deviation 0.011 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | 0.058 g/dL | Standard Deviation 0.01 |
| Placebo | Breath Alcohol Concentration (BrAC) | 0.061 g/dL | Standard Deviation 0.008 |
Primary
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200mg Cannabidiol | Breath Alcohol Concentration (BrAC) | 0.066 g/dL | Standard Deviation 0.014 |
| 30mg Cannabidiol, | Breath Alcohol Concentration (BrAC) | 0.067 g/dL | Standard Deviation 0.013 |
| Placebo | Breath Alcohol Concentration (BrAC) | 0.069 g/dL | Standard Deviation 0.011 |