Synthetic THC And Blood Pressure

Mayo Clinic

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Blood Pressure

Treatments: Drug: Placebo; Drug: Dronabinol

Study type: Interventional

Funder types: Other

Identifiers

NCT07231965

25-008291

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Dronabinol Group

Active Comparator group

Description:

Patients taking Dronabinol first and Placebo second

Treatment:

Drug: Dronabinol

Drug: Placebo

Placebo Group

Active Comparator group

Description:

Patients taking Placebo first and Dronabinol second

Treatment:

Drug: Dronabinol

Drug: Placebo