NCT07231965

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

November 13, 2025

Last Update Submit

January 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Baroreflex Sensitivity

    Baseline, 30 days

  • Sympathetic control

    Baseline, 30 days

  • Flow Mediated Dilation

    Baseline, 30 days

  • Aortic Wave Reflection

    Baseline, 30 days

Study Arms (2)

Dronabinol Group

ACTIVE COMPARATOR

Patients taking Dronabinol first and Placebo second

Drug: DronabinolDrug: Placebo

Placebo Group

ACTIVE COMPARATOR

Patients taking Placebo first and Dronabinol second

Drug: DronabinolDrug: Placebo

Interventions

Patients will take one 10 mg dose of Dronabinol.

Dronabinol GroupPlacebo Group

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

Dronabinol GroupPlacebo Group

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Recreational occasional Cannabis use (Consuming THC less than 2 times a week)
  • years of age
  • Biological male or female

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Virend Somers

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations