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Completed

NCT Number: NCT06105138

Cannabidiol Effects on Blood Alcohol Level and Intoxication

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University

Fort Collins, Colorado, 80523, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

200mg Cannabidiol oral solution

Dietary Supplement

200mg cannabidiol administered in the laboratory prior to a standard dose of alcohol.

The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment).

30mg Cannabidiol oral solution

Dietary Supplement

30mg cannabidiol administered in the laboratory prior to a standard dose of alcohol.

The water-soluble product is standardized to 5.0% cannabidiol, 0.0% THC and composed of reverse-osmosis water, gum arabic, cannabidiol, MCT (Medium Chain Triglyceride) oil and citric acid. The same lot of Caliper water soluble CBD was used for both the 30 mg and 200 mg test variable. All CBD was sourced from the same lot of CDB isolate. The Caliper commercial product conforms to all standards set forth by the CDPHE (Colorado Dept of Public Health and Environment).

Placebo

Dietary Supplement

Placebo administered in the laboratory prior to a standard dose of alcohol.

The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%.

Primary outcomes

  1. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  2. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 2 (30 minutes after Timepoint 1)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  3. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 3 (30 minutes after Timepoint 2)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  4. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 4 (30 minutes after Timepoint 3)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  5. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 5 (30 minutes after Timepoint 4)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  6. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 6 (30 minutes after Timepoint 6)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  7. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 7 (30 minutes after Timepoint 6)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  8. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 8 (30 minutes after Timepoint 9)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  9. Breath Alcohol Concentration (BrAC)

    Time frame: Timepoint 9 (30 minutes after Timepoint 8)

    Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session

  10. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  11. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  12. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  13. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  14. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  15. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  16. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  17. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  18. Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

    Time frame: 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.

  19. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  20. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  21. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  22. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  23. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  24. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  25. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  26. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  27. Biphasic Effects of Alcohol--Sedation Subscale

    Time frame: 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

  28. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  29. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  30. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  31. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  32. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  33. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  34. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  35. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

  36. Alcohol Urge Questionnaire (AUQ

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Official study title

Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2023
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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