Blood Pressure
Conditions
Brief summary
To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology
Interventions
DRUGDronabinol
Patients will take one 10 mg dose of Dronabinol.
DRUGPlacebo
Patients will take one 10mg dose of a Placebo Pill.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Baseline, 30 days | 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). |
| Heart Rate | Baseline, 30 days | Heart Rate is the number of contractions (beats) that the heart makes per minute. This will be measured in bpm (beats per minute) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baroreflex Sensitivity | Baseline, 30 days | 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. |
| Sympathetic control | Baseline, 30 days | 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 |
| Flow Mediated Dilation | Baseline, 30 days | Flow Mediated Dilation will be measured by ultrasonography of brachial artery, reported as an absolute change in arterial diameter from resting baseline |
| Aortic Wave Reflection | Baseline, 30 days | Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index |
Countries
United States
Contacts
CONTACTNicholas Wozniak
PRINCIPAL_INVESTIGATORVirend Somers
Mayo Clinic
Outcome results
None listed