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CompletedNCT06105138Updated Oct 23, 2024Results posted

Cannabidiol Effects on Blood Alcohol Level and Intoxication

An interventional study of 200mg Cannabidiol oral solution and 30mg Cannabidiol oral solution in Alcohol Use Disorder, sponsored by Colorado State University. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by Colorado State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Mar 2021, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alcohol Use Disorder

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Keywords

  • alcohol
  • cannabidiol
  • craving
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 37 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Colorado State University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    200mg Cannabidiol

    - A single dose of 200mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water).

    Dietary Supplement: 200mg Cannabidiol oral solution

  • Experimental
    30mg Cannabidiol,

    - A single dose of 30mg commercially available (product code T-L-A-5) water-soluble solution supplied by Caliper Foods, to be consumed orally (mixed with water).

    Dietary Supplement: 30mg Cannabidiol oral solution

  • Placebo comparator
    Placebo

    - A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water).

    Dietary Supplement: Placebo

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%.

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
Milestone200mg Cannabidiol, 30mg Cannabidiol, Placebo200mg Cannabidiol, Placebo, 30mg Cannabidiol30mg Cannabidiol, Placebo, 200mg Cannabidiol30mg Cannabidiol, 200mg Cannabidiol, PlaceboPlacebo, 200mg Cannabidiol, 30mg CannabidiolPlacebo, 30mg Cannabidiol, 200mg Cannabidiol
Started6447123
Completed330583
Not completed314240

Outcome measures

PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC)0.065 ± 0.017.067 ± .015.070 ± .014
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC)0.066 ± 0.0140.067 ± 0.0130.069 ± 0.011
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC)0.059 ± 0.0110.058 ± 0.0100.061 ± 0.008
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC)0.048 ± 0.0100.049 ± 0.0090.050 ± 0.008
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC).040 ± .009.040 ± .009.041 ± .007
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC)0.032 ± .009.032 ± .010.034 ± .007
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC).023 ± .010.024 ± .011.027 ± .008
PrimaryBreath 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)
Reported as:
Mean · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC).016 ± .011.018 ± .011.020 ± .008
PrimaryBreath 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)
Reported as:
Median · g/dL
Breath Alcohol Concentration (BrAC)
g/dL200mg Cannabidiol30mg Cannabidiol,Placebo
Breath Alcohol Concentration (BrAC).013 ± .012.012 ± .011.013 ± .009
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale9.40 ± 15.4713.64 ± 20.0114.07 ± 18.15
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale26.17 ± 17.5427.82 ± 16.2025.74 ± 16.27
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale19.66 ± 15.2421.39 ± 14.5618.78 ± 15.01
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale15.10 ± 14.3314.14 ± 12.2515.78 ± 14.73
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale11.07 ± 12.1811.96 ± 11.1711.56 ± 13.00
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale9.07 ± 9.868.18 ± 9.858.81 ± 11.94
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale6.86 ± 9.606.68 ± 10.228.33 ± 12.04
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale5.44 ± 8.275.81 ± 7.665.93 ± 8.53
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale4.96 ± 7.634.89 ± 7.556.78 ± 8.31
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale2.66 ± 5.184.18 ± 6.063.78 ± 5.21
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale12.31 ± 10.0413.75 ± 10.6611.81 ± 10.01
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale15.45 ± 12.4014.07 ± 11.3113.41 ± 12.01
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale15.76 ± 13.9117.86 ± 14.4114.15 ± 13.96
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale15.41 ± 14.5313.29 ± 12.3612.89 ± 13.86
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale14.86 ± 15.0112.11 ± 13.1412.00 ± 14.05
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale11.72 ± 14.699.96 ± 11.3010.48 ± 12.19
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale8.31 ± 12.319.22 ± 10.788.74 ± 10.85
PrimaryBiphasic 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)
Reported as:
Mean · score on a scale
Biphasic Effects of Alcohol--Sedation Subscale
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Biphasic Effects of Alcohol--Sedation Subscale8.07 ± 10.866.70 ± 8.096.89 ± 7.90
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ19.0 ± 7.9519.82 ± 7.7918.26 ± 8.19
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ22.76 ± 10.5223.14 ± 11.2623.96 ± 10.51
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ21.79 ± 9.4221.25 ± 10.08221.93 ± 10.08
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ19.93 ± 8.3819.21 ± 9.5519.56 ± 8.73
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ19.03 ± 7.7618.46 ± 9.0818.67 ± 8.50
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ18.59 ± 8.6719.21 ± 10.5817.19 ± 7.77
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ17.79 ± 7.8917.54 ± 9.4916.85 ± 7.61
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ16.83 ± 8.2117.67 ± 10.5116.11 ± 7.98
PrimaryAlcohol 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)
Reported as:
Mean · score on a scale
Alcohol Urge Questionnaire (AUQ
score on a scale200mg Cannabidiol30mg Cannabidiol,Placebo
Alcohol Urge Questionnaire (AUQ17.04 ± 8.1017.41 ± 9.7815.59 ± 7.78

Adverse events

Collected over Participants were assessed during each study visit in related to baseline (for up to three study visits per participant), with each visit lasting 5 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
200mg Cannabidiol0/29 (0%)0/29 (0%)0/29 (0%)
30mg Cannabidiol,0/28 (0%)0/28 (0%)0/28 (0%)
Placebo0/27 (0%)0/27 (0%)0/27 (0%)

Baseline characteristics

All 36 individuals who participated in the study (i.e., who completed at least one study session) were included in baseline descriptive analyses

Age, Continuous
Age, Continuous(years)Entire Sample
Mean26.5 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)Entire Sample
Female19
Male17
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Entire Sample
White34
Mixed Race1
Asian1
Region of Enrollment
Region of Enrollment(participants)Entire Sample
United States36
Alcohol Use Disorders Identification Test
Alcohol Use Disorders Identification Test(units on a scale)Entire Sample
Mean9.7 ± 4.7
Beck Depression Inventory
Beck Depression Inventory(units on a scale)Entire Sample
Mean7.3 ± 6.3
Beck Anxiety Inventory
Beck Anxiety Inventory(units on a scale)Entire Sample
Mean4.4 ± 5.8
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Study locations

1 site
  • Colorado State University
    Fort Collins, Colorado 80523, United States
09

References and documents

Publications

  • Karoly HC, Drennan ML, Prince MA, Zulic L, Dooley G. Consuming oral cannabidiol prior to a standard alcohol dose has minimal effect on breath alcohol level and subjective effects of alcohol. Psychopharmacology (Berl). 2023 May;240(5):1119-1129. doi: 10.1007/s00213-023-06349-z. Epub 2023 Mar 20. PubMed 36939855 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 27, 2021
  • Informed consent form · Feb 18, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual (de-identified) participant data is to be made available to other researchers.

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06105138
Lead sponsor
Colorado State University
Responsible party
Sponsor
First posted
Oct 27, 2023
Start date
Mar 9, 2021
Primary completion
Mar 3, 2022
Completion
Mar 3, 2022
Results posted
Sep 19, 2024
Last update
Oct 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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