Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2026-02-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Dronabinol Group
Patients taking Dronabinol first and Placebo second
Dronabinol
Patients will take one 10 mg dose of Dronabinol.
Placebo
Patients will take one 10mg dose of a Placebo Pill.
Placebo Group
Patients taking Placebo first and Dronabinol second
Dronabinol
Patients will take one 10 mg dose of Dronabinol.
Placebo
Patients will take one 10mg dose of a Placebo Pill.
Interventions
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Dronabinol
Patients will take one 10 mg dose of Dronabinol.
Placebo
Patients will take one 10mg dose of a Placebo Pill.
Eligibility Criteria
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Inclusion Criteria
* 21 - 40 years of age
* Biological male or female
Exclusion Criteria
* 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
21 Years
40 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Virend Somers, MD, PhD
Principal Investigator
Principal Investigators
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Virend Somers
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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25-008291
Identifier Type: -
Identifier Source: org_study_id
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