Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity (NCT04114903) | Clinical Trial Compass
CompletedNot Applicable
Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
United States233 participantsStarted 2019-11-08
Plain-language summary
This study tests the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects. Blood levels of THC and CBD, inflammatory biomarkers, and insulin resistance will be measured in both studies.
Who can participate
Age range
21 Years – 40 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:
* Able to provide informed consent
* Cannabis users in Study A must have smoked or vaped cannabis at least once since January 1st 2014 with no negative effects but NOT used in the past three months
* Cannabis users in Study B must have been a regular (at least weekly) user for at least a year
* Non-users in Study B cannot have used any cannabis in the previous year
* Weight stable (\<5 pound fluctuation in the past six months)
* Planning to remain in the Boulder-Denver area for the next month
* Fasting blood glucose greater than or equal to 55 mg/dl and less than or equal to 126 mg/dl
* Cannabis users in Study A must endorse knowledge of the procedure(s) for smoking or vaping cannabis
Exclusion Criteria:
* Known auto-immune disease
* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
* Daily tobacco (cigarette, E-cigs, smokeless) user, given the impact of tobacco smoking on insulin function
* Blood alcohol level greater than 0 at screening
* Current use of medications for glucose lowering, immunosuppression, or anti-inflammation
* Acute illness
* Current use of psychotropic medications
* Current diagnosis of diabetes
* Heavy drinking as defined by an Alcohol Use Disorders Test (AUDIT)
* Females can not be pregnant or trying to become pregnant
* Females can not be nursing mothers
* Have donated blood in the 8 weeks before the study or intend to donate blood in the 8 weeks after the…
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
Markers of Inflammation
Timeframe: Study A: Difference between cytokines at baseline and cytokines one week later after acute use of cannabis product. Study B: Change from baseline to four weeks
2
Change in Matsuda Index of Insulin Sensitivity
Timeframe: Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
3
Change in Plasma Glucose
Timeframe: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
4
Change in Plasma Insulin
Timeframe: Study A: Baseline versus one week later after acute use of cannabis product. Study B: Baseline versus four weeks later