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To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol Group | Active Comparator | Patients taking Dronabinol first and Placebo second |
|
| Placebo Group | Active Comparator | Patients taking Placebo first and Dronabinol second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | Patients will take one 10 mg dose of Dronabinol. |
|
| 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 |
| 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 |
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Inclusion Criteria
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Wozniak | Contact | 507-255-8794 | wozniak.nicholas@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Virend Somers | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Patients will take one 10mg dose of a Placebo Pill. |
|
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 |