Clinical Trials Directory

Trials / Completed

CompletedNCT05999344

Alcohol and Cannabis Concentrates Co-Administration

Exploring Intoxication During Acute Alcohol and Cannabis Concentrate Co-Administration: A Focus on Cannabinoid Content and Order Effects

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
146 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
21 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERcommercially available cannabis administered prior to commercially available alcoholSelf administration of cannabis prior to researcher administered alcohol
OTHERcommercially available alcohol administered prior to commercially available cannabisResearcher administered alcohol prior to self-administration of cannabis

Timeline

Start date
2021-12-16
Primary completion
2024-08-01
Completion
2024-08-01
First posted
2023-08-21
Last updated
2025-11-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05999344. Inclusion in this directory is not an endorsement.