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Alcohol + Cannabis Co-Use for Substance Use
N/A
Recruiting
Led By Hollis C Karoly, PhD
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Awards & highlights
Study Summary
This trial will look at the effects of combining alcohol with cannabis concentrates to answer questions about how order of use and THC levels impacts outcomes. Participants will consume alcohol & cannabis in a mobile lab & complete surveys/cognitive tasks for 4 hours.
Who is the study for?
This trial is for adults aged 21-65 who regularly use cannabis concentrates and are heavy drinkers, but do not have a history of certain mental health disorders or major medical conditions that make alcohol or cannabis unsafe. Participants must not be pregnant, breastfeeding, trying to conceive, using illicit drugs (other than THC), or on psychotropic/steroid medications.Check my eligibility
What is being tested?
The study examines the effects of consuming alcohol before cannabis concentrate versus consuming cannabis concentrate before alcohol. It measures blood alcohol levels, heart rate, subjective drug effects and cognitive function over a four-hour period in a mobile lab at participants' homes.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, generally combining alcohol with high-THC cannabis can increase impairment, risk of over-intoxication, potential anxiety or paranoia episodes and may affect cognitive functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ARCI Marijuana Scale
Alcohol Urge Questionnaire (AUQ)
Breath Alcohol Level (BrAC)
+2 moreSecondary outcome measures
Biphasic Effects of Alcohol Scale (BAES)
Blood-THC
Profile of Mood States (POMS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cannabis before alcoholExperimental Treatment1 Intervention
Participants are randomly assigned to go inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose.
Group II: Alcohol before CannabisExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Institute of Cannabis Research (ICR)--Colorado State University, PuebloUNKNOWN
Colorado State UniversityLead Sponsor
125 Previous Clinical Trials
38,279 Total Patients Enrolled
2 Trials studying Alcoholism
86 Patients Enrolled for Alcoholism
Hollis C Karoly, PhDPrincipal InvestigatorColorado State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not drink more than the defined limits for heavy drinking.I have a health condition that makes it unsafe for me to consume alcohol or cannabis.I am not currently taking any psychotropic (except for antidepressants) or steroid medications.I am between 21 and 65 years old.I have not used illegal drugs, except for THC, in the last 60 days.I am willing to choose and use a specific concentrate product for the study.I have or had psychosis, bipolar disorder, major depression with thoughts of suicide.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabis before alcohol
- Group 2: Alcohol before Cannabis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research open to adults 18 years and older?
"This particular trial is only open to individuals aged 21-65. For minors, there are 34 trials available and 254 for those over 65 years old."
Answered by AI
What is the eligibility criterion for individuals to partake in this experiment?
"This medical investigation requires 80 participants aged 21-65 with a confirmed diagnosis of alcoholism. Additionally, the following criteria must be met: Cannabis concentrate use in last 12 months, Regular usage of legal cannabis (min 3x/week for past 3 months), Consent to obtain their own concentrate product for study purposes."
Answered by AI
Is access to this trial still available for participants?
"Clinicaltrials.gov reports this medical trial is currently open for recruitment, having initially been posted on December 16th 2021 and last updated August 11th 2023."
Answered by AI
What is the cap on patient enrollment for this research project?
"Indeed. Clinicaltrials.gov details the fact that this research is actively recruiting for 80 patients from one site, with initial posting on December 16th 2021 and most recent modification occurring August 11th 2023."
Answered by AI
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