Cannabidiol Effects on Blood Alcohol Level and Intoxication

Sponsor

Colorado State University (Other)

Overall Status

Completed

CT.gov ID

NCT06105138

Collaborator

(none)

Enrollment

Location

Arms

11.8

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Dietary Supplement: 200mg Cannabidiol oral solution Dietary Supplement: 30mg Cannabidiol oral solution Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2021

Actual Primary Completion Date :

Mar 3, 2022

Actual Study Completion Date :

Mar 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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).
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 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 Comparator: Placebo A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water).	Dietary Supplement: Placebo Placebo administered in the laboratory prior to a standard dose of alcohol. The placebo was made up for the study and contained reverse-osmosis water, gum arabic, MCT (Medium Chain Triglyceride) oil, citric acid, plus the addition of a natural food color, used at <0.1%.

Arm

Intervention/Treatment

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

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).

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

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 Comparator: Placebo

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

Dietary Supplement: Placebo

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

Outcome Measures

Primary Outcome Measures

Breath Alcohol Concentration (BrAC) [At each of the three study sessions, BrAC is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale [At each of the three study sessions, BAES stimulation is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
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 [At each of the three study session, BAES sedation is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
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 [t each of the three study sessions, AUQ is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
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
Subjective Effects of Alcohol Scale (SEAS)--High Arousal Positive Subscale [At each of the three study session, SEAS is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
Subjective Effects of Alcohol Scale (SEAS) is a standard self-report measure for assessing subjective mood responses to alcohol. The SEAS includes 14 items with response option that range from 1-10. The high arousal positive subscale is a combination of four items from this scale.
Subjective Effects of Alcohol Scale (SEAS)--Low Arousal Positive Subscale [At each of the three study session, SEAS is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
Subjective Effects of Alcohol Scale (SEAS) is a standard self-report measure for assessing subjective mood responses to alcohol. The SEAS includes 14 items with response option that range from 1-10. The Low Arousal Positive Subscale is a combination of four items from this scale
Flanker Inhibitory Control and Attention Task (NIH Toolbox) [At each of the three study session, the Flanker Inhibitory Control and Attention Task is administered at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
The Flanker task measures both a participant's attention and inhibitory control. The test requires the participant to focus on a given stimulus while inhibiting attention to stimuli flanking it.

Secondary Outcome Measures

DRUID Psychomotor Battery [At each of the three study session, DRUID is administered at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)]]
The DRUID is a mobile app that tests for cognitive and motor impairment, and has been shown to detect impairment related to alcohol and cannabis use. total score ranges from 0-100 where higher is worse.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado State University	Fort Collins	Colorado	United States	80523

Sponsors and Collaborators

Colorado State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colorado State University

ClinicalTrials.gov Identifier:

NCT06105138

Other Study ID Numbers:

1903

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Colorado State University

alcohol

cannabidiol

craving

Additional relevant MeSH terms:

Alcoholism

Cannabidiol

Pharmaceutical Solutions

Study Results

No Results Posted as of Oct 30, 2023