Alcohol and Cannabis Concentrates Co-Administration

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999344
• Other study ID #: 2161
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Colorado State University
• Contact: Hollis C Karoly, PhD
• Phone: 970-491-3677
• Email: hollis.karoly[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Cannabis Use
• Marijuana Abuse

Intervention

Other:
• commercially available cannabis administered prior to commercially available alcohol
Self administration of cannabis prior to researcher administered alcohol
• commercially available alcohol administered prior to commercially available cannabis
Researcher administered alcohol prior to self-administration of cannabis

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	Institute of Cannabis Research (ICR)--Colorado State University, Pueblo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath Alcohol Level (BrAC)	Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Primary	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	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Primary	Heart Rate (HR)	Heart rate (beats per minute) is measured using a finger pulse oximeter	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Primary	ARCI Marijuana Scale	The ARCI scale measures subjective responses to cannabis. total score ranges from 0-12 where higher is worse	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Primary	DRUID Psychomotor Battery	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.	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Secondary	Blood-THC	We will quantify levels of THC in the blood before and after the participant uses their cannabis product	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
Secondary	Biphasic Effects of Alcohol Scale (BAES)	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)	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Secondary	Profile of Mood States (POMS)	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)	Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)