Synthetic THC And Blood Pressure

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-40
SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recreational occasional Cannabis use (Consuming THC less than 2 times a week)

21 - 40 years of age

Biological male or female

Disqualifiers

BMI > 35 kg/m2

Diagnosed psychiatric disorders

Hypotension

History of seizures

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dronabinol

    Drug

    Patients will take one 10 mg dose of Dronabinol.

  • Placebo

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Dronabinol GroupActive comparator 2 interventions
Group B: Placebo GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline, 30 days
2

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)

Time frame
Baseline, 30 days

Secondary outcomes

1

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.

Time frame
Baseline, 30 days
2

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

Time frame
Baseline, 30 days
3

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

Time frame
Baseline, 30 days
4

Aortic Wave Reflection

Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index

Time frame
Baseline, 30 days

Other outcomes

Sponsors and contacts

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