- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05999344
Alcohol and Cannabis Concentrates Co-Administration
Exploring Intoxication During Acute Alcohol and Cannabis Concentrate Co-Administration: A Focus on Cannabinoid Content and Order Effects
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523
- Colorado State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 21-65 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alcohol before Cannabis
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.
|
Researcher administered alcohol prior to self-administration of cannabis
|
|
Experimental: Cannabis before alcohol
Participants are randomly assigned to go inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose.
|
Self administration of cannabis prior to researcher administered alcohol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breath Alcohol Level (BrAC)
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
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
|
Alcohol Urge Questionnaire (AUQ)
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
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
|
Heart Rate (HR)
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
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
|
ARCI Marijuana Scale
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
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
|
DRUID Psychomotor Battery
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.
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood-THC
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
|
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)
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)
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
|
Profile of Mood States (POMS)
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)
|
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hollis C Karoly, PhD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Substance-Related Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Alcoholism
- Marijuana Abuse
- Psychomotor Disorders
- Organic Chemicals
- Alcohols
- Ethanol
Other Study ID Numbers
- 2161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use Disorder
-
Technische Universität DresdenCharite University, Berlin, Germany; Central Institute of Mental Health, MannheimRecruitingAlcoholism | Methamphetamine-dependence | Substance Use Disorders | Cocaine Use Disorder | Alcohol Use Disorder (AUD) | Cannabis Use Disorder | Amphetamine Use DisorderGermany
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
Indiana UniversityPatient-Centered Outcomes Research InstituteRecruitingAdolescent | Alcohol Use | Mild Alcohol Use Disorder | Mild Substance Use DisorderUnited States
-
University of North Carolina, Chapel HillCompletedAlcohol Use Disorder, Mild | Alcohol Use Disorder, ModerateUnited States
-
University of BernRecruitingAlcohol Use Disorder (AUD) | Substance Use Disorder (SUD) | Cocaine Use Disorder (CUD)Switzerland
-
Université du Québec à Trois-RivièresCompletedAlcohol Use, Unspecified | Alcohol Use Disorder, MildCanada
-
University of Wisconsin, MadisonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruitingAlcohol Use Disorder | Alcohol Use Disorder (AUD)United States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Technische Universität DresdenCharite University, Berlin, Germany; Central Institute of Mental Health, MannheimRecruitingAlcoholism | Substance Use Disorders | Alcohol Use Disorder (AUD)Germany
-
University of Notre DameNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Use | Opioid Use Disorder | Alcohol Use Disorder | Opioid UseUnited States
Clinical Trials on commercially available alcohol administered prior to commercially available cannabis
-
Milton S. Hershey Medical CenterCompletedBehavioral Responses to Bright Light Therapy in EldersUnited States
-
AtriCure, Inc.RecruitingPostural Tachycardia Syndrome | Inappropriate Sinus TachycardiaUnited States, Belgium
-
MedtronicNeuroTerminatedPain, Chronic | Pain, IntractableUnited States
-
University of the PacificCompletedCardiovascular DiseasesUnited States
-
Massachusetts General HospitalHarvard School of Public Health (HSPH)Completed
-
Universitair Ziekenhuis BrusselCompletedInfertility, FemaleBelgium
-
Direct Flow Medical, Inc.UnknownAortic Valve StenosisUnited States
-
MedtronicRecruitingChronic Pain | Intractable PainUnited States
-
University of UtahRecruiting