Alcohol and Cannabis Concentrates Co-Administration (NCT05999344) | Clinical Trial Compass
CompletedNot Applicable
Alcohol and Cannabis Concentrates Co-Administration
United States146 participantsStarted 2021-12-16
Plain-language 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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Breath Alcohol Level (BrAC)
Timeframe: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
2
Alcohol Urge Questionnaire (AUQ)
Timeframe: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
3
Heart Rate (HR)
Timeframe: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
4
ARCI Marijuana Scale
Timeframe: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
5
DRUID Psychomotor Battery
Timeframe: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
. 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.