Cannabidiol Effects on Blood Alcohol Level and Intoxication

Study Overview
=================
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.

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

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: 200mg Cannabidiol oral solution
* Dietary Supplement: 30mg Cannabidiol oral solution
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200mg Cannabidiol<br>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<br>* 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).<br>|
| Experimental: 30mg Cannabidiol<br>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<br>* 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).<br>|
| Placebo Comparator: Placebo<br>A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water). | Dietary Supplement: Placebo<br>* 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%.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath Alcohol Concentration (BrAC) | Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session | At each of the three study sessions, BrAC is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures) | 
| 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. | At each of the three study sessions, BAES stimulation is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)] | 
| 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 | At each of the three study session, BAES sedation is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)] | 
| 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 | t each of the three study sessions, AUQ is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)] | 
| Subjective Effects of Alcohol Scale (SEAS)--High Arousal Positive Subscale | 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. | 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)--Low Arousal Positive Subscale | 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 | At each of the three study session, SEAS is measured at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)] | 
| Flanker Inhibitory Control and Attention Task (NIH Toolbox) | 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. | 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)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DRUID Psychomotor Battery | 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. | At each of the three study session, DRUID is administered at baseline (pre ingestion) and again every 30 minutes post ingestion (9 measures)] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol, cannabidiol, craving