Clinical trial NCT05999344: Alcohol and Cannabis Concentrates Co-Administration
Official title: Exploring Intoxication During Acute Alcohol and Cannabis Concentrate Co-Administration: A Focus on Cannabinoid Content and Order Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Cannabis Use
Keywords: alcohol
cannabis
polysubstance use
psychomotor impairment
cannabis concentrates
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Institute of Cannabis Research (ICR)--Colorado State University, Pueblo
First posted: 2023-08-21
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 21-65 years old,
2. Heavy drinkers (for men, \>4 drinks in one occasion, or \>14 drinks per week; for women, \>3 drinks in one occasion, or \>7 drinks per week)
3. Regular users of legal-market cannabis (at least 3x/week in past 3 months)
4. Have experience using cannabis concentrates within the last year
5. Willing to obtain a concentrate product of their choice for use in the study.

Exclusion Criteria:

1. Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD)
2. Pregnant, breastfeeding or trying to become pregnant
3. Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders
4. Current use of psychotropic (except anti-depressants) or steroid medications
5. Report illicit drug use in past 60-days or fail drug screen (drug screen tests for the presence of amphetamines, benzodiazepines, cocaine, THC, methamphetamine and opioids; only THC is allowed to be present in urine in order to be eligible to participate in the study
6. Major medical condition contraindicating alcohol and/or cannabis consumption (e.g., liver disease, heart disease, or being told by a doctor that it is unsafe to consume alcohol or cannabis due to a medical condition)
7. Have participated in another research study in the past 8 weeks.

Primary outcomes:
measure: Breath Alcohol Level (BrAC)
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
measure: Alcohol Urge Questionnaire (AUQ)
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
measure: Heart Rate (HR)
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
measure: ARCI Marijuana Scale
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
measure: DRUID Psychomotor Battery
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Secondary outcomes:
measure: Blood-THC
timeFrame: 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
measure: Biphasic Effects of Alcohol Scale (BAES)
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
measure: Profile of Mood States (POMS)
timeFrame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Hollis C Karoly, PhD
role: PRINCIPAL_INVESTIGATOR
References: