Cannabidiol Effects on Blood Alcohol Level and Intoxication

NCT06105138 | Completed Results

• 1 other identifier: 1903
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

alcohol; cannabidiol; craving

Outcome Measures

Primary Outcomes (36)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 1 (20 minutes after alcohol consumption is complete)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 2 (30 minutes after Timepoint 1)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 3 (30 minutes after Timepoint 2)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 4 (30 minutes after Timepoint 3)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 5 (30 minutes after Timepoint 4)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 6 (30 minutes after Timepoint 6)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 7 (30 minutes after Timepoint 6)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 8 (30 minutes after Timepoint 9)

• Breath Alcohol Concentration (BrAC)

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

  Timepoint 9 (30 minutes after Timepoint 8)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 1 (20 minutes after alcohol consumption is complete)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 2 (30 minutes after Timepoint 1)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 3 (30 minutes after Timepoint 2)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 4 (30 minutes after Timepoint 3)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 5 (30 minutes after Timepoint 4)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 6 (30 minutes after Timepoint 5)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 7 (30 minutes after Timepoint 6)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 8 (30 minutes after Timepoint 7)

• Biphasic Effects of Alcohol (BAES)--Stimulation Subscale

  BAES stimulation will be measured by self-report repeatedly during the experimental session. The total score on the stimulation subscale ranges from 0-70 where higher is more stimulated.

  Timepoint 9 (30 minutes after Timepoint 8)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 1 (20 minutes after alcohol consumption is complete)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 2 (30 minutes after Timepoint 1)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 3 (30 minutes after Timepoint 2)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 4 (30 minutes after Timepoint 3)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 5 (30 minutes after Timepoint 4)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 6 (30 minutes after Timepoint 5)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 7 (30 minutes after Timepoint 6)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 8 (30 minutes after Timepoint 7)

• Biphasic Effects of Alcohol--Sedation Subscale

  BAES sedation will be measured by self-report repeatedly during the experimental session. The total score on the sedation subscale ranges from 0-70 where higher is more sedated

  Timepoint 9 (30 minutes after Timepoint 8)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 1 (20 minutes after alcohol consumption is complete)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 2 (30 minutes after Timepoint 1)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 3 (30 minutes after Timepoint 4)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 4 (30 minutes after Timepoint 3)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 5 (30 minutes after Timepoint 4)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 6 (30 minutes after Timepoint 5)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 7 (30 minutes after Timepoint 6)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 8 (30 minutes after Timepoint 7)

• Alcohol Urge Questionnaire (AUQ

  The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse

  Timepoint 9 (30 minutes after Timepoint 8)

Study Arms (3)

200mg Cannabidiol

EXPERIMENTAL

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

Dietary Supplement: 200mg Cannabidiol oral solution

30mg Cannabidiol,

EXPERIMENTAL

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

Dietary Supplement: 30mg Cannabidiol oral solution

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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).

200mg Cannabidiol

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).

30mg Cannabidiol,

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%.

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Publications (1)

• 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.

  PMID: 36939855 RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Hollis Karoly
• Organization: Colorado State University

hollis.karoly@colostate.edu

970-491-3677

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: March 9, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: October 23, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available upon request.

Locations

US (1)