Alcohol and Cannabis Co-Use and the Gut-Brain Axis

Completed

Conditions studied: Cannabis Use, Alcohol Use, Inflammation

In brief

This observational study aims to improve our understanding of how legal market cannabis use impacts acute and long-term alcohol use, the microbiota-gut-brain-axis (MGBA), and neurobehavioral alcohol use phenotypes such as impulsivity, impaired cognitive functioning, and craving, among individuals who regularly use both alcohol and cannabis. Over a period of one month, subjects will participate in this three-visit study. Blood samples will be collected to allow for the assessment of inflammatory markers and cannabinoids, a fecal sample will be collected to allow for the analysis of the gut microbiome, and participants will complete cognitive and impulsivity tasks and provide craving ratings during the course of an alcohol self-administration procedure. Subjects will also participate in two 14-day daily diary data collection periods between lab sessions. Daily diary data collection will be used to assess the effects of cannabis use on alcohol use and craving longitudinally.

Key facts

Study ID

NCT04998006

Run by

University of Colorado, Denver

People needed

77

Starts

2022-02-25

Expected to finish

2024-12-23

Last updated by the study team

2026-05-15

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21-60 years of age
• Able to provide consent
• Heavy drinker, defined as: for men, consuming more than 4 drinks on any day or more than 14 drinks per week OR, for women, consuming more than 3 drinks on any day or more than 7 drinks per week over the last 3 months.
• Regular legal-market cannabis smoker, defined as using smoked flower cannabis obtained from a dispensary at least 3 days per/week over the past 3 months
• Willing to abstain from cannabis use for 14 days
• We are prioritizing the recruitment of participants in the Fort Collins/Loveland area

You may not qualify if…

• Daily tobacco use*** (Vape and Hooka included)
• Actively seeking treatment for alcohol use disorder or other substance use disorder
• Females cannot be pregnant, breastfeeding or trying to become pregnant
• Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders
• Immune-relevant disease (e.g., osteoarthritis, HIV, cancer, recent infection, other autoimmune disorder) or currently taking an immune-modulating medication***
• Current use of psychotropic medications (except anti-depressants )
• Report illicit drug use in past 60-days or fail drug screen
• Major medical condition that contraindicates the consumption of alcohol or cannabis.
• Use of an antibiotic medication in the past 3 months
• Current GI disorder including: inflammatory bowel disease, irritable bowel disease, diverticular disease, peptic ulcer/gastritis and gastroesophageal reflux disease.
• Use of probiotic or supplement drinks at least once per week over the last 3 months

Where it is running

• CU Anschutz School of Medicine — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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