Synthetic THC And Blood Pressure

Effects Of Cannabis Products On Blood Pressure Control

To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Drug: Dronabinol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Nicholas Wozniak; Phone Number: 507-255-8794; Email: wozniak.nicholas@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Recreational occasional Cannabis use (Consuming THC less than 2 times a week)
• 21 - 40 years of age
• Biological male or female

Exclusion Criteria

• BMI > 35 kg/m2
• Diagnosed psychiatric disorders
• Hypotension
• History of seizures
• History of substance abuse or recreational drug use or positive urine drug screen

• History of uncontrolled disease including:

  • Cardiovascular
  • Pulmonary
  • Gastrointestinal
  • Pancreatic
  • Hepatic
  • Renal
  • Hematological
  • Endocrine (including Type I Diabetes)
  • Neurological
  • Urological
  • Sleep disorders
• Pregnant or breastfeeding
• Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs
• Prescribed CYP2C9 and/or CYP3A4 inhibitors
• History of shift work or rotating shifts within 1 month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dronabinol Group; Patients taking Dronabinol first and Placebo second	Drug: Dronabinol; Patients will take one 10 mg dose of Dronabinol.; Drug: Placebo; Patients will take one 10mg dose of a Placebo Pill.
Active Comparator: Placebo Group; Patients taking Placebo first and Dronabinol second	Drug: Dronabinol; Patients will take one 10 mg dose of Dronabinol.; Drug: Placebo; Patients will take one 10mg dose of a Placebo Pill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Blood pressure is the force exerted by circulating blood on the walls of the arteries as it is pumped through the body. Blood pressure will be measured as a ratio of systolic/diastolic (mmHg).	Baseline, 30 days
Heart Rate	Heart Rate is the number of contractions (beats) that the heart makes per minute. This will be measured in bpm (beats per minute)	Baseline, 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baroreflex Sensitivity	Baroreflex sensitivity will be assessed using beat-by-beat blood pressure, heart rate, and Sympathetic nerve activity collected continuously for at least 5min. This will be measured in ms/mmHg.	Baseline, 30 days
Sympathetic control	Sympathetic control will be measured by microneurography of peroneal or fibular nerve, reported as bursts of sympathetic activity per minute or normalized to 100 heart beats	Baseline, 30 days
Flow Mediated Dilation	Flow Mediated Dilation will be measured by ultrasonography of brachial artery, reported as an absolute change in arterial diameter from resting baseline	Baseline, 30 days
Aortic Wave Reflection	Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index	Baseline, 30 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Virend Somers, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: 25-008291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No