Trials / Completed
CompletedNCT06105138
Cannabidiol Effects on Blood Alcohol Level and Intoxication
Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Colorado State University · Academic / Other
- Sex
- All
- Age
- 21 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
| 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). |
| 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%. |
Timeline
- Start date
- 2021-03-09
- Primary completion
- 2022-03-03
- Completion
- 2022-03-03
- First posted
- 2023-10-27
- Last updated
- 2024-10-23
- Results posted
- 2024-09-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06105138. Inclusion in this directory is not an endorsement.