A Study Of Synthetic THC And Sleep

Overview

About this study

The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 21 – 70 years of age

  • Biological male or female

  • AHI between 15 – 50 events/hour

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

  • Pregnant or breastfeeding

  • Use of certain antimicrobial, chemotherapeutic, anticoagulant, hypoglycemic, anti-inflammatory, psychotropic, and antihistamine drugs

  • Prescribed CYP2C9 and/or CYP3A4 inhibitors

  • Severe OSA that in the investigator’s judgment should only begin CPAP treatment

  • Prior upper airway surgery for snoring or OSA as an adult

  • Significant defect in nasal patency due to anatomical abnormality or uncontrolled rhinitis

  • Bariatric surgery within 2 years

  • Medically managed weight-loss program within 6 months

  • Noninvasive treatment for OSA within 1 month (self-report)

  • History of shift work or rotating shifts within 1 month

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 08/26/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Virend Somers

Contact us for the latest status

Contact information:

Nicholas Wozniak

(507) 255-8794

wozniak.nicholas@mayo.edu

More information

Publications

Publications are currently not available