Clinical trial NCT06105138: Cannabidiol Effects on Blood Alcohol Level and Intoxication
Official title: Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: alcohol
cannabidiol
craving
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 1 (20 minutes after alcohol consumption is complete)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 2 (30 minutes after Timepoint 1)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 3 (30 minutes after Timepoint 2)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 4 (30 minutes after Timepoint 3)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 5 (30 minutes after Timepoint 4)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 6 (30 minutes after Timepoint 6)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 7 (30 minutes after Timepoint 6)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 8 (30 minutes after Timepoint 9)
measure: Breath Alcohol Concentration (BrAC)
timeFrame: Timepoint 9 (30 minutes after Timepoint 8)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 1 (20 minutes after alcohol consumption is complete)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 2 (30 minutes after Timepoint 1)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 3 (30 minutes after Timepoint 2)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 4 (30 minutes after Timepoint 3)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 5 (30 minutes after Timepoint 4)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 6 (30 minutes after Timepoint 5)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 7 (30 minutes after Timepoint 6)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 8 (30 minutes after Timepoint 7)
measure: Biphasic Effects of Alcohol (BAES)--Stimulation Subscale
timeFrame: Timepoint 9 (30 minutes after Timepoint 8)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 1 (20 minutes after alcohol consumption is complete)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 2 (30 minutes after Timepoint 1)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 3 (30 minutes after Timepoint 2)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 4 (30 minutes after Timepoint 3)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 5 (30 minutes after Timepoint 4)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 6 (30 minutes after Timepoint 5)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 7 (30 minutes after Timepoint 6)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 8 (30 minutes after Timepoint 7)
measure: Biphasic Effects of Alcohol--Sedation Subscale
timeFrame: Timepoint 9 (30 minutes after Timepoint 8)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 1 (20 minutes after alcohol consumption is complete)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 2 (30 minutes after Timepoint 1)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 3 (30 minutes after Timepoint 4)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 4 (30 minutes after Timepoint 3)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 5 (30 minutes after Timepoint 4)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 6 (30 minutes after Timepoint 5)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 7 (30 minutes after Timepoint 6)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 8 (30 minutes after Timepoint 7)
measure: Alcohol Urge Questionnaire (AUQ
timeFrame: Timepoint 9 (30 minutes after Timepoint 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References:
citation: 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.