Alcohol and Cannabis Concentrates Co-Administration

NCT05999344 | Completed

• 1 other identifier: 2161
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Cannabis Use

Keywords

alcohol; cannabis; polysubstance use; psychomotor impairment; cannabis concentrates

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (3)

• Blood-THC

  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

• Biphasic Effects of Alcohol Scale (BAES)

  Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)

• Profile of Mood States (POMS)

  Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)

Study Arms (2)

Alcohol before Cannabis

EXPERIMENTAL

Participants are randomly assigned to receive the standardized alcohol dose during the experimental session prior to going inside their residence to self-administer their preferred cannabis concentrate product.

Other: commercially available alcohol administered prior to commercially available cannabis

Cannabis before alcohol

EXPERIMENTAL

Participants are randomly assigned to go inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose.

Other: commercially available cannabis administered prior to commercially available alcohol

Interventions

commercially available cannabis administered prior to commercially available alcohol OTHER

Self administration of cannabis prior to researcher administered alcohol

Cannabis before alcohol

commercially available alcohol administered prior to commercially available cannabis OTHER

Researcher administered alcohol prior to self-administration of cannabis

Alcohol before Cannabis

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,
• 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)
• Regular users of legal-market cannabis (at least 3x/week in past 3 months)
• Have experience using cannabis concentrates within the last year
• Willing to obtain a concentrate product of their choice for use in the study.

You may not qualify if:

• Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD)
• Pregnant, breastfeeding or trying to become pregnant
• Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders
• Current use of psychotropic (except anti-depressants) or steroid medications
• 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
• 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)
• Have participated in another research study in the past 8 weeks.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Institute of Cannabis Research, Colorado State University Pueblo: collaborator
• Colorado State University: collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Conditions

Alcoholism; Marijuana Abuse; Psychomotor Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Hollis C Karoly, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: December 16, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)