Recruiting
Phase 1

THC

Sponsor:

UCLA

Code:

NCT05322213

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

THC

Placebo

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT05322213

Start date

Aug 22, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and Females 21-70 years old at the time of screening.
  • Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study.
  • Male subjects must be willing to use clinically acceptable method of contraception during the entire study.
  • Have a clinical diagnosis of Type 2 Diabetes on a stable medication regimen for at least 3 months.
  • BMI > 25 kg/m2).
  • HbA1c < 10%).
  • Negative urine toxicology result at screening visit.
  • Able to provide written informed consent approved by an Institutional Review Board (IRB).

Exclusion Criteria:

  • History or presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might put the participant at increased risk of adverse events (e.g., history of psychotic disorder, clinically significant mood and/or anxiety disorder, liver, or renal disease).
  • No prior history of myocardial infarction, stroke or heart failure.
  • Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion.
  • Hemoglobin < 9g/dL.
  • Liver enzymes ≥ 2 times upper normal limit and/or clinical signs/symptoms consistent with liver disease, including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, or edema.
  • History of clinically significant adverse events associated with cannabis intoxication (e.g., severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension).
  • History of seizures, head trauma, or other history of CNS insult that could predispose the participant to seizures.
  • Use of any THC containing products within 30 days prior to the screening visit.
  • Current use of tobacco products.
  • Individuals who are pregnant or lactating/breastfeeding.
  • Current use of insulin to treat Type 2 Diabetes.
  • Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits.
  • Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Active THC

Daily, inhaled, flexible dose of cannabis product with THC.

placebo comparator: Placebo Cannabis

Daily, inhaled, flexible dose of cannabis product without THC.

Interventions

THC

2-Week, once daily, flexible dose, inhaled THC

Placebo

2-Week, once daily, flexible dose, inhaled placebo

Primary outcome measure

  • Change in Glucose Disposal Rate [ Time Frame: 6 weeks ]
  • Change in Vascular Endothelial Function [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Todd May, MS

858-246-2169tmay@health.ucsd.edu

Locations

UC San Diego Altman Clinical & Translational Research Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Todd May, MS

t1dresearch@health.ucsd.edu

Principal Investigator:

Jeremy Pettus, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • THC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-15.