30 Participants Needed

THC for Type 2 Diabetes

TM
Overseen ByTodd May, MS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, San Diego

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have a stable medication regimen for at least 3 months before joining the study.

What evidence supports the effectiveness of the drug THC for Type 2 Diabetes?

Research suggests that THC, a component of marijuana, may influence insulin secretion and glucose metabolism, which are important for managing diabetes. Studies in animals have shown that activating certain cannabinoid receptors can improve glucose tolerance, indicating potential benefits for diabetes management.12345

Is THC safe for humans, especially those with type 2 diabetes?

There is limited safety data on THC specifically for type 2 diabetes, but related studies suggest that cannabis use can affect metabolic regulation and may alter treatment adherence in diabetes patients. Additionally, rimonabant, a drug targeting the same system as THC, was generally well-tolerated but had some side effects like mood disorders and nausea.26789

How does the drug THC differ from other treatments for type 2 diabetes?

THC (Tetrahydrocannabinol) is unique because it interacts with the endocannabinoid system, which is involved in regulating metabolism and energy balance, potentially affecting insulin secretion and glucose levels. Unlike standard diabetes treatments, THC may also influence immune responses and has been shown to modify insulin secretion in experimental models, offering a novel approach to managing diabetes-related metabolic changes.59101112

What is the purpose of this trial?

This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.

Eligibility Criteria

Adults aged 21-70 with Type 2 Diabetes, a BMI over 25 kg/m2, and stable diabetes medication for at least 3 months can join. They must not use tobacco or THC products recently, have no significant illnesses or heart issues, and agree to contraception if of childbearing potential.

Inclusion Criteria

I am willing to use contraception throughout the study.
I agree to use two forms of birth control during the study.
I have been on stable diabetes medication for over 3 months.
See 6 more

Exclusion Criteria

You have experienced serious problems from using cannabis, such as extreme anxiety, paranoia, or severe changes in heart rate or blood pressure.
I have a history of conditions like seizures or head injuries that could make me more likely to have seizures.
I am willing and able to follow the study rules and attend all appointments.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment Session 1

Participants receive either THC or placebo for 2 weeks with metabolic and endothelial assessments

2 weeks
4 visits (in-person)

Washout

Participants undergo a 4-week washout period before switching treatments

4 weeks
1 visit (in-person)

Treatment Session 2

Participants receive the opposite treatment (THC or placebo) for 2 weeks with metabolic and endothelial assessments

2 weeks
4 visits (in-person)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Placebo
  • THC
Trial Overview The trial is testing the effects of THC on glucose metabolism in Type 2 Diabetes patients compared to a placebo. Participants will undergo blood tests and other assessments before and after two weeks of treatment to measure changes.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active THCActive Control2 Interventions
Daily, inhaled, flexible dose of cannabis product with THC.
Group II: Placebo CannabisPlacebo Group2 Interventions
Daily, inhaled, flexible dose of cannabis product without THC.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Center for Medicinal Cannabis Research

Collaborator

Trials
19
Recruited
630+

Center For Medicinal Cannabis Research at UC San Diego Health

Collaborator

Trials
1
Recruited
30+

References

Marijuana Use and Type 2 Diabetes Mellitus: a Review. [2018]
Role of cannabinoid CB2 receptors in glucose homeostasis in rats. [2016]
Regulation, function, and dysregulation of endocannabinoids in models of adipose and beta-pancreatic cells and in obesity and hyperglycemia. [2013]
Activation of cannabinoid CB1 receptors induces glucose intolerance in rats. [2016]
Δ9-Tetrahydrocannabinol Treatment Modifies Insulin Secretion in Pancreatic Islets from Prediabetic Mice Under Hypercaloric Diet. [2023]
Cannabis Use Is Associated With Increased Risk for Diabetic Ketoacidosis in Adults With Type 1 Diabetes: Findings From the T1D Exchange Clinic Registry. [2020]
Cannabis use prevalence among individuals with diabetes: The National Survey on Drug Use and Health, 2005-2018. [2021]
Use of cannabinoid CB1 receptor antagonists for the treatment of metabolic disorders. [2022]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
The endocannabinoid system: a promising target for the management of type 2 diabetes. [2019]
Examination of the immunosuppressive effect of delta9-tetrahydrocannabinol in streptozotocin-induced autoimmune diabetes. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Pharmacokinetics of cannabinoids. [2019]
Δ9-tetrahydrocannabinol treatment improved endothelium-dependent relaxation on streptozotocin/nicotinamide-induced diabetic rat aorta. [2015]
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