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Alcohol and Cannabis Concentrates Co-Administration

Primary Purpose

Alcohol Use Disorder, Cannabis Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
commercially available cannabis and commercially available alcohol
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder focused on measuring alcohol, cannabis, polysubstance use, psychomotor impairment, cannabis concentrates

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Colorado State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alcohol + Cannabis

Arm Description

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 or randomly assigned to going inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose. All participants receive alcohol and cannabis, however, the order of ingestion is randomly assigned.

Outcomes

Primary Outcome Measures

Breath Alcohol Level (BrAC)
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
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
Heart Rate (HR)
Heart rate (beats per minute) is measured using a finger pulse oximeter
ARCI Marijuana Scale
The ARCI scale measures subjective responses to cannabis. total score ranges from 0-12 where higher is worse
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.

Secondary Outcome Measures

Blood-THC
We will quantify levels of THC in the blood before and after the participant uses their cannabis product
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)
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)

Full Information

First Posted
August 11, 2023
Last Updated
August 22, 2023
Sponsor
Colorado State University
Collaborators
Institute of Cannabis Research (ICR)--Colorado State University, Pueblo
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1. Study Identification

Unique Protocol Identification Number
NCT05999344
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
Institute of Cannabis Research (ICR)--Colorado State University, Pueblo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Cannabis Use
Keywords
alcohol, cannabis, polysubstance use, psychomotor impairment, cannabis concentrates

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, randomized order of administration
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol + Cannabis
Arm Type
Experimental
Arm Description
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 or randomly assigned to going inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose. All participants receive alcohol and cannabis, however, the order of ingestion is randomly assigned.
Intervention Type
Other
Intervention Name(s)
commercially available cannabis and commercially available alcohol
Intervention Description
Self administration of cannabis and researcher administered alcohol
Primary Outcome Measure Information:
Title
Breath Alcohol Level (BrAC)
Description
Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Title
Alcohol Urge Questionnaire (AUQ)
Description
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
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Title
Heart Rate (HR)
Description
Heart rate (beats per minute) is measured using a finger pulse oximeter
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Title
ARCI Marijuana Scale
Description
The ARCI scale measures subjective responses to cannabis. total score ranges from 0-12 where higher is worse
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Title
DRUID Psychomotor Battery
Description
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.
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Secondary Outcome Measure Information:
Title
Blood-THC
Description
We will quantify levels of THC in the blood before and after the participant uses their cannabis product
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
Title
Biphasic Effects of Alcohol Scale (BAES)
Description
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)
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Title
Profile of Mood States (POMS)
Description
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)
Time Frame
Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hollis C Karoly, PhD
Phone
970-491-3677
Email
hollis.karoly@colostate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollis C Karoly, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hollis C. Karoly, PhD
First Name & Middle Initial & Last Name & Degree
Hollis C. Karoly, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Alcohol and Cannabis Concentrates Co-Administration

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