Colorado State University
Fort Collins, Colorado, 80523, United States
NCT Number: NCT05999344
The goal of this study is to learn about the effects of combining alcohol with cannabis concentrate products which contain high levels of THC. The main question[s] it aims to answer are, 1) How does the order in which someone consumes THC and alcohol in a given co-use session impact outcomes such as blood alcohol level, heart rate or subjective drug effects, and 2) how does THC percentage in cannabis influence outcomes following alcohol and cannabis co-administration. Participants will be scheduled for our mobile lab to come to their residence. During the session, they will:
* consume a standardized dose of alcohol as well as use their own preferred cannabis concentrate product. * they will then remain in our mobile lab for about 4 hours and complete some surveys as well as do some cognitive tasks on an iPad every 30 minutes. * They will also have their blood drawn three times throughout the session, and will periodically be asked to blood into a breathalyzer to measure blood alcohol level.
Researchers will compare people who use alcohol prior to cannabis to those who use cannabis prior to alcohol to determine whether order of use impacts outcomes.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Fort Collins, Colorado, 80523, United States
Individuals who drink alcohol commonly report co-using cannabis, and the increasing availability of new formulations of highly potent cannabis products on the legal market means that alcohol is likely being combined with cannabis products that contain high levels of delta-9-tetrahydrocannabinol (THC). There is limited existing research on the acute effects of cannabis products containing high amounts of THC, such as cannabis concentrates, which often contain up to 90% THC. Existing laboratory data suggests that consuming alcohol and cannabis together (compared to alcohol alone) is associated with reduced BAC, delayed time to peak blood alcohol concentration (BAC), longer duration of intoxication, and increased subjective intoxication, but it is unknown how cannabis concentrates may interact with alcohol to influence these outcomes. There is also a lack of research regarding whether timing or order of use matters, though recent survey data from our group and others suggests that using alcohol before cannabis may confer additional risk compared to using cannabis prior to alcohol. The present study leverages a federally-compliant mobile laboratory design to explore the acute effects of self-administered cannabis concentrates alongside a standardized dose of alcohol. The investigators will recruit a community sample of individuals who regularly use alcohol and cannabis to participate study sessions in our mobile laboratory. The sessions will involve individuals consuming cannabis concentrates of their choice (that they acquire themselves) along with a standardized dose of alcohol. Half of the participants will use the alcohol before cannabis, and the other half will use the cannabis before alcohol. The investigators will measure intoxication and biological outcomes every 30 minutes for 4 hours. The investigators will also measure differences between those who used alcohol before cannabis and those who used cannabis before alcohol.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Self administration of cannabis prior to researcher administered alcohol
Researcher administered alcohol prior to self-administration of cannabis
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
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
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Heart rate (beats per minute) is measured using a finger pulse oximeter
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
The ARCI scale measures subjective responses to cannabis. total score ranges from 0-12 where higher is worse
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
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.
Time frame: Blood is drawn immediately prior to alcohol and cannabis consumption, again 60 minutes post alcohol administration start time, and again 240 minutes post alcohol start time
We will quantify levels of THC in the blood before and after the participant uses their cannabis product
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
The BAES measures the stimulating and sedating effects of alcohol and is validated for use in laboratory settings. This scale produces a stimulation subscale (total score ranges from 0-70 where higher is more stimulated) and a sedation subscale (total score ranging from 0-70 where higher is more sedated)
Time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
The POMS is a self-report rating scale that assesses state-level, distinct mood states. The POMS produces multiple subscales (Tension, depression, anger, fatigue, confusion, vigour, as well as a total mood disturbance scale)
University of Colorado, Denver
Other
Exploring Intoxication During Acute Alcohol and Cannabis Concentrate Co-Administration: A Focus on Cannabinoid Content and Order Effects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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