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Treatment for Inflammation (FRACTAL Trial)

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up self-report measures administered one time at baseline. differences in alcohol and cannabis use throughout study procedures will be measured as predictors of these self-report scores
Awards & highlights

Summary

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.

Eligible Conditions
  • Inflammation
  • Cannabis Use
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between reward value of alcohol when cannabis is on board (session b) compared to when it is not (session a). this task will also be administered at baseline (when not intoxicated) to compare sober state-level alcohol reward
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between reward value of alcohol when cannabis is on board (session b) compared to when it is not (session a). this task will also be administered at baseline (when not intoxicated) to compare sober state-level alcohol reward for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute alcohol consumption
Daily alcohol consumption
Gut microbiota
+2 more
Secondary study objectives
Change in Alcohol Craving (Visual-Analog Scale
Intestinal permeability
NIH Toolbox Flanker Test
+4 more
Other study objectives
Change in Rey Auditory Verbal Learning Test (RAVLT)
Exploratory: Daily Follow-up Messages
Plasma Gamma-Glutamyl Transferase (GGT)

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor
131 Previous Clinical Trials
38,157 Total Patients Enrolled
1 Trials studying Inflammation
222 Patients Enrolled for Inflammation
University of Colorado, BoulderOTHER
122 Previous Clinical Trials
29,098 Total Patients Enrolled
6 Trials studying Inflammation
1,309 Patients Enrolled for Inflammation
Hollis C. Karoly, PhDPrincipal InvestigatorColorado State University
~7 spots leftby Jan 2025
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