Cannabidiol Effects on Blood Alcohol Level and Intoxication

Not Applicable

Completed

Interventions: Dietary Supplement: 200mg Cannabidiol oral solution
Dietary Supplement: 30mg Cannabidiol oral solution
Dietary Supplement: Placebo

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
200mg Cannabidiol	200mg Cannabidiol oral solution	- 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).
30mg Cannabidiol,	30mg Cannabidiol oral solution	- 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).
Placebo	Placebo	- A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water).

Primary Outcome Measures

Name	Time	Method
Breath Alcohol Concentration (BrAC)	Timepoint 9 (30 minutes after Timepoint 8)	Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Biphasic Effects of Alcohol (BAES)--Stimulation Subscale	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.
Biphasic Effects of Alcohol--Sedation Subscale	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
Alcohol Urge Questionnaire (AUQ	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