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NCT Number: NCT04114903

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

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Cannabis Use Chemically-Induced Disorders Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Marijuana Abuse Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Innovation and Creativity

Boulder, Colorado, 80301, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 study.

Treatment and study plan

Study A: Single use of cannabis flower product

Other

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 use

Other

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).

Primary outcomes

  1. 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

    Change in Circulating Levels of Cytokines (TNF-α, IL-1B, IL-4, IL-6, IL-10, IL-13, MCP-1)

  2. Change in Matsuda Index of Insulin Sensitivity

    Time frame: Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks

    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)

    Matsuda Index is calculated as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration))

  3. Change in Plasma Glucose

    Time frame: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks

    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.

  4. Change in Plasma Insulin

    Time frame: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks

    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.

Secondary outcomes

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

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

    Interviewer administered assessment of number of minutes of mild, moderate, and vigorous physical activity over the previous seven days.

  2. Sleep Quality

    Time frame: Study A: Baseline to one week following baseline Study B: Baseline to four weeks following baseline

    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.

  3. Marijuana Consumption Questionnaire

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

    Frequency and quantity of cannabis use, age of first use, peer use, perceived risk from cannabis, and perceived availability of cannabis

  4. Marijuana Dependence Scale

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

    Based on DSM V criteria that were converted to a self-report to assess dependence and other problems related to the use of cannabis

  5. Marijuana Withdrawal Checklist

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

    A 15-item scale used to collect information on withdrawal symptoms participants may be experiencing due to lack of use of marijuana

  6. The Alcohol Use Disorder Identification Test (AUDIT)

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

    Standardized assessment of the extent of alcohol use and problems related to alcohol use

  7. Timeline Follow-Back of Substance Use

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

    Calendar-based assessment of daily substance use for the 30 days prior to the baseline session only for both studies

  8. SF-12 Health Survey

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

    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

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

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

    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

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

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

    Self-report measure of a single item comprising six descriptive categories ranging from inactive to very active

Other outcomes

  1. Daily online survey of cannabis use, alcohol use, exercise and diet

    Time frame: Study B only: Daily for four weeks between baseline and second study visit

    Daily surveys sent to Study B participants during the four-week period between study visits querying for cannabis use, alcohol use, minutes of exercise, and consumption of fruits and vegetables

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • University of Colorado, Denver

Registry information

Acronym: SONIC

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2019
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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