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Not yet recruiting NCT07231965

Synthetic THC And Blood Pressure

Phase II / Phase III Interventional Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dronabinol, Placebo.
Who it may be relevant to
Registry conditions: Blood Pressure. Basic parameters: 21 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects Of Cannabis Products On Blood Pressure Control

Overview

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

Interventions

  • Drug Dronabinol
    Patients will take one 10 mg dose of Dronabinol.
  • Drug Placebo
    Patients will take one 10mg dose of a Placebo Pill.

Primary outcome measures

  • Blood Pressure [Time frame: Baseline, 30 days]
  • Heart Rate [Time frame: Baseline, 30 days]
Secondary outcome measures (4)
  • Baroreflex Sensitivity [Time frame: Baseline, 30 days]
  • Sympathetic control [Time frame: Baseline, 30 days]
  • Flow Mediated Dilation [Time frame: Baseline, 30 days]
  • Aortic Wave Reflection [Time frame: Baseline, 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07231965 · 25-008291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗