Alcohol Use DisorderNCT06105138
Cannabidiol Effects on Blood Alcohol Level and Intoxication
A study testing 200mg Cannabidiol oral solution and 30mg Cannabidiol oral solution in people with Alcohol Use Disorder, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- 200mg Cannabidiol oral solution and 30mg Cannabidiol oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 3 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects
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.
Read the 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
- Alcohol Use Disorder
- Being tested
- 200mg Cannabidiol oral solution, 30mg Cannabidiol oral solution, Placebo
- Keywords
- alcohol, cannabidiol, craving
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200mg Cannabidiol oral solutionDietary supplement
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).
30mg Cannabidiol oral solutionDietary supplement
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).
PlaceboDietary supplement
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%.
| Study group | Role | What they receive |
|---|---|---|
| 200mg Cannabidiol | Experimental | - 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). Receives: Dietary Supplement: 200mg Cannabidiol oral solution |
| 30mg Cannabidiol, | Experimental | - 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). Receives: Dietary Supplement: 30mg Cannabidiol oral solution |
| Placebo | Placebo comparator | - A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 1 (20 minutes after alcohol consumption is complete)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 2 (30 minutes after Timepoint 1)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 3 (30 minutes after Timepoint 2)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 4 (30 minutes after Timepoint 3)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 5 (30 minutes after Timepoint 4)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 6 (30 minutes after Timepoint 6)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 7 (30 minutes after Timepoint 6)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 8 (30 minutes after Timepoint 9)
Breath Alcohol Concentration (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Measured: Timepoint 9 (30 minutes after Timepoint 8)
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.
Measured: Timepoint 1 (20 minutes after alcohol consumption is complete)
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.
Measured: Timepoint 2 (30 minutes after Timepoint 1)
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.
Measured: Timepoint 3 (30 minutes after Timepoint 2)
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.
Measured: Timepoint 4 (30 minutes after Timepoint 3)
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.
Measured: Timepoint 5 (30 minutes after Timepoint 4)
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.
Measured: Timepoint 6 (30 minutes after Timepoint 5)
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.
Measured: Timepoint 7 (30 minutes after Timepoint 6)
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.
Measured: Timepoint 8 (30 minutes after Timepoint 7)
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.
Measured: Timepoint 9 (30 minutes after Timepoint 8)
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
Measured: Timepoint 1 (20 minutes after alcohol consumption is complete)
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
Measured: Timepoint 2 (30 minutes after Timepoint 1)
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
Measured: Timepoint 3 (30 minutes after Timepoint 2)
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
Measured: Timepoint 4 (30 minutes after Timepoint 3)
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
Measured: Timepoint 5 (30 minutes after Timepoint 4)
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
Measured: Timepoint 6 (30 minutes after Timepoint 5)
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
Measured: Timepoint 7 (30 minutes after Timepoint 6)
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
Measured: Timepoint 8 (30 minutes after Timepoint 7)
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
Measured: Timepoint 9 (30 minutes after Timepoint 8)
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
Measured: Timepoint 1 (20 minutes after alcohol consumption is complete)
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
Measured: Timepoint 2 (30 minutes after Timepoint 1)
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
Measured: Timepoint 3 (30 minutes after Timepoint 4)
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
Measured: Timepoint 4 (30 minutes after Timepoint 3)
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
Measured: Timepoint 5 (30 minutes after Timepoint 4)
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
Measured: Timepoint 6 (30 minutes after Timepoint 5)
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
Measured: Timepoint 7 (30 minutes after Timepoint 6)
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
Measured: Timepoint 8 (30 minutes after Timepoint 7)
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
Measured: Timepoint 9 (30 minutes after Timepoint 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start9 Mar 2021
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105138
- Sponsor's protocol ID
- 1903
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2023
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual (de-identified) participant data is to be made available to other researchers.
Publications
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.
PubMed 36939855
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects
- ClinicalTrials.gov ID
- NCT06105138
- Acronym / sponsor ID
- 1903
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol, cannabidiol, craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200mg Cannabidiol | Experimental | Dietary Supplement: 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, | Experimental | Dietary Supplement: 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 comparator | Dietary Supplement: Placebo- A single dose of water-soluble Placebo solution supplied by Caliper Foods, to be consumed orally (mixed with water). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 200mg Cannabidiol oral solution200mg 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 | 200mg Cannabidiol |
| 30mg Cannabidiol oral solution30mg 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, |
| PlaceboPlacebo 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%. | Dietary supplement | Placebo |
Primary outcome
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 3 (30 minutes after Timepoint 2)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 6 (30 minutes after Timepoint 6)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: Timepoint 8 (30 minutes after Timepoint 9)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Breath Alcohol Concentration (BrAC)
Time frame: 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
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 3 (30 minutes after Timepoint 2)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 6 (30 minutes after Timepoint 5)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
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 (BAES)--Stimulation Subscale
Time frame: Timepoint 8 (30 minutes after Timepoint 7)
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 (BAES)--Stimulation Subscale
Time frame: 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
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 3 (30 minutes after Timepoint 2)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 6 (30 minutes after Timepoint 5)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: Timepoint 8 (30 minutes after Timepoint 7)
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
Biphasic Effects of Alcohol--Sedation Subscale
Time frame: 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
Time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 2 (30 minutes after Timepoint 1)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 3 (30 minutes after Timepoint 4)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 4 (30 minutes after Timepoint 3)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 5 (30 minutes after Timepoint 4)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 6 (30 minutes after Timepoint 5)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 7 (30 minutes after Timepoint 6)
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
Alcohol Urge Questionnaire (AUQ
Time frame: Timepoint 8 (30 minutes after Timepoint 7)
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
Alcohol Urge Questionnaire (AUQ
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36939855Karoly 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.
- Individual participant dataSharing planned: Yes. Individual (de-identified) participant data is to be made available to other researchers.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200mg Cannabidiol oral solution and 30mg Cannabidiol oral solution in people with Alcohol Use Disorder, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Alcohol Concentration (BrAC) (time frame: Timepoint 1 (20 minutes after alcohol consumption is complete)). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06105138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.