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Type 2 DiabetesSONICNCT04114903

Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity

An observational study of Type 2 Diabetes and Obesity, run by University of Colorado, Boulder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 40 years
Conditions the study is for
Type 2 Diabetes, Obesity, Cannabis Use
What is being tested?
Study A: Single use of cannabis flower product and Study B: Ad libitum cannabis use for four weeks or no cannabis use
How many people
233 participants
Where
1 siteUnited States
Study dates
8 Nov 2019to 1 Dec 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • All sexes
  • Adult

Study population: Community Sample

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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 study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Innovation and Creativity

    Boulder, Colorado, 80301

Other trials in United States

About this study

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.

Read the detailed description

According to the National Institute of Diabetes and Digestive and Kidney Diseases, over 30 million people in the US have diabetes, and just over 84 million people have pre-diabetes. Concurrently, 30 states and the District of Columbia have legalized cannabis for medical and/or recreational use and over the past decade, cannabis use among adults has more than doubled.

Public perception and some scientific data suggest that cannabis causes acute over-eating, creating concern that public and legal acceptance of cannabis use will worsen the obesity epidemic in the United States, where more than two-thirds of US adults (68.8%) are currently overweight or obese. Paradoxically, cross sectional data demonstrate associations between chronic cannabis use and lower body mass index (BMI), prevalence of obesity, insulin resistance, waist circumference, and actual rates of type 2 diabetes despite data supporting higher caloric intake acutely.

This study examines 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.

Being tested
Study A: Single use of cannabis flower product, Study B: Ad libitum cannabis use for four weeks or no cannabis use
Keywords
Diabetes, Obesity, Cannabis, Insulin Sensitivity
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Insulin Resistance, Diabetes Mellitus, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study A: Single use of cannabis flower productOther

    Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (~14% CBD/0% THC), 2) THC (~14% THC/0% CBD), or 3) THC+CBD (~7% THC/7% CBD).

  • Study B: Ad libitum cannabis use for four weeks or no cannabis useOther

    Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (~14% CBD/0% THC), 2) THC (~14% THC/0% CBD), or 3) THC+CBD (~7% THC/7% CBD).

Study groups in NCT04114903
Study groupRoleWhat they receive
Study AAdults balanced across the weight spectrum who have tried cannabis at least once with no negative reaction but are not regular users.
Receives: Other: Study A: Single use of cannabis flower product
Study BSample of current cannabis users and non-users balanced across the weight spectrum who are matched on age, gender, BMI and physical activity.
Receives: Other: Study B: Ad libitum cannabis use for four weeks or no cannabis use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Markers of Inflammation

    Change in Circulating Levels of Cytokines (TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4). Results are reported as a composite score of TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4

    Measured: 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

    Calculation of Insulin Sensitivity using changes in fasting plasma glucose (FPG) and fasting plasma insulin (FPI).

    Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes after ingestion of 75 grams oral glucose during oral glucose tolerance test (OGTT). Values across the timepoints were combined to create a Matsuda Index score as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration)).

    Higher scores mean higher sensitive to insulin and that your body more efficiently clears glucose from your bloodstream, thus higher scores are better.

    Measured: 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

    Change in glucose over time after ingestion of 75 grams oral glucose measured during during oral glucose tolerance test (OGTT). Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.

    Measured: 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

    Change in insulin over time after ingestion of 75 grams oral glucose measured during OGTT. Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.

    Measured: Study A: Baseline versus one week later after acute use of cannabis product. Study B: Baseline versus four weeks later

Secondary outcomes (10)
  1. Stanford Seven-Day Physical Activity Recall (PAR)

    Interviewer administered assessment of number of minutes of moderate to vigorous physical activity over the previous seven days. Scores are reported as total minutes in the last week summed across moderate, hard, and very hard activity levels.

    Measured: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

  2. Sleep Quality

    Pittsburgh Sleep Quality Index: Measurement of the quality and patterns of sleep from poor to good measuring seven domains (e.g., latency, duration, disturbances) over the last 2 weeks. Participants' scores are reported as a global score of the summed seven component scores together ranging from 0 to 21, where higher scores indicate worse sleep and a global score of 5 or above indicates poor sleep quality.

    Measured: Study A: Baseline only Study B: Baseline to four weeks following baseline

  3. Marijuana Consumption Questionnaire

    Times per day of cannabis flower use from 0 to 6. Includes all participants in Study A and only cannabis users in Study B.

    Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline

  4. Marijuana Dependence Scale

    This is a self-report scale based on DSM-5 criteria to assess dependence and other problems related to the use of cannabis. Scores are reported as a sum across the 11 items with yes/no options, ranging from 0 to 11, with higher scores indicating more dependence symptoms. Includes all participants in Study A and only cannabis users in Study B.

    Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline

  5. Marijuana Withdrawal Checklist

    A 15-item scale used to collect information on withdrawal symptoms that participants may be experiencing due to the lack of use of marijuana. Options range from 0 (none) to 3 (severe) for each question and are summed to create a final score ranging from 0 to 45. Includes all participants in Study A and only cannabis users in Study B.

    Measured: Study A: Assessed at follow-up, one week following baseline. Study B: Assessed at follow-up, four weeks following baseline.

  6. The Alcohol Use Disorder Identification Test (AUDIT)

    Standardized assessment of the extent of alcohol use and problems related to alcohol use. Scores are summed and range from 0 to 40 with higher scores indicating more hazardous alcohol use.

    Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline

  7. Timeline Follow-Back of Substance Use

    Calendar-based assessment of daily substance use for the 30 days prior to the baseline session for both studies. The average days of smoked cannabis use in the last 30 days are reported.

    Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline

  8. SF-12 Health Survey

    The SF-12 Health Survey is a 12-item questionnaire used to assess general health and well-being and includes domains of physical functioning, role-physical, pain, general health, vitality, social functioning, role-emotional and mental health. Only the mental component was analyzed. Scores are calculated using a weighted algorithm with scores ranging from 0 to 100; scores greater than 50 meaning better than average health and scores worse than 50 meaning worse than average health.

    Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline

  9. Nutrition Data System for Research 24-Hour Dietary Recall

    Interviewer administered recall measure developed by the University of Minnesota Nutrition Coordinating Center (NCC), that facilitates the standardized collection of 24-hour dietary recall data. Healthy Eating Index (HEI) total scores are reported for each participant, which is a measure of healthy eating on a scale of 0 (poor eating) to 100 (very healthy eating). Scores above 80 indicate a good diet, and scores below 80 indicate a diet in need of improvement.

    Measured: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

  10. Stanford Leisure-Time Activity Categorical Item (L-Cat)

    Self-report measure of a single item comprising six descriptive categories ranging from inactive (1) to very active (6).

    Measured: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2019
  2. Study start8 Nov 2019
  3. Primary completion1 Dec 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04114903
Sponsor's protocol ID
1R01DA050515
Acronym
SONIC
Status last verified
Jul 2026
First submitted
6 Sep 2019
Last updated
6 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bryan AD, Skrzynski CJ, Yang J, Chrystal KA, Bidwell LC, Hutchison KE, Perreault L. Inhaling high THC cannabis acutely increases inflammation but not insulin sensitivity: a quasi-randomized trial. Sci Rep. 2026 Jul 16. doi: 10.1038/s41598-026-62837-0. Online ahead of print.

    PubMed 42463843
  • Skrzynski CJ, Bryan AD, Schmiege SJ. Quasi-randomization to Cannabinoid Condition in Studies of US Legal Market Cannabis: Characteristics of Accepters Versus Decliners of Condition Assignment. Prev Sci. 2026 Mar;27(3):441-450. doi: 10.1007/s11121-026-01893-4. Epub 2026 Mar 13.

    PubMed 41820717

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes and Obesity, run by University of Colorado, Boulder at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Markers of Inflammation (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04114903, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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SONIC Clinical Trial NCT04114903 | AzTrials