Blood PressurePhase 2/3NCT07231965
Synthetic THC And Blood Pressure
A Phase 2/3 study testing Dronabinol in people with Blood Pressure, run by Mayo Clinic at 1 site in United States.
Trial summary
To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recreational occasional Cannabis use (Consuming THC less than 2 times a week)
- 21 - 40 years of age
- Biological male or female
Who cannot join
- 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:
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effects Of Cannabis Products On Blood Pressure Control
To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology
- Conditions
- Blood Pressure
- Being tested
- Dronabinol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Patients will take one 10 mg dose of Dronabinol.
PlaceboDrug
Patients will take one 10mg dose of a Placebo Pill.
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol Group | Active comparator | Patients taking Dronabinol first and Placebo second Receives: Drug: Dronabinol; Drug: Placebo |
| Placebo Group | Active comparator | Patients taking Placebo first and Dronabinol second Receives: Drug: Dronabinol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Baseline, 30 days
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: Baseline, 30 days
Aortic Wave Reflection
Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index
Measured: Baseline, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231965
- Sponsor's protocol ID
- 25-008291
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Cannabis Products On Blood Pressure Control
- ClinicalTrials.gov ID
- NCT07231965
- Acronym / sponsor ID
- 25-008291
- Conditions
- Blood Pressure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effects of Dronabinol use on blood pressure and neurovascular physiology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronabinol Group | Active comparator | Drug: Dronabinol, Drug: PlaceboPatients taking Dronabinol first and Placebo second |
| Placebo Group | Active comparator | Drug: Dronabinol, Drug: PlaceboPatients taking Placebo first and Dronabinol second |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recreational occasional Cannabis use (Consuming THC less than 2 times a week)
- 21 - 40 years of age
- Biological male or female
Key exclusion criteria (21 listed)
- BMI > 35 kg/m2
- Diagnosed psychiatric disorders
- Hypotension
- History of seizures
- History of substance abuse or recreational drug use or positive urine drug screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolPatients will take one 10 mg dose of Dronabinol. | Drug | Dronabinol Group, Placebo Group |
| PlaceboPatients will take one 10mg dose of a Placebo Pill. | Drug | Dronabinol Group, Placebo Group |
Primary outcome
Blood Pressure
Time frame: 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
Time frame: 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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virend Somers principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dronabinol in people with Blood Pressure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Wozniak (507-255-8794, wozniak.nicholas@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Baseline, 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.