A Study Of Synthetic THC And Sleep

Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Dronabinol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chieko Allgauer; Phone Number: 507-422-3499; Email: allgauer.chieko@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dronabinol; Patients assigned to the Dronabinol arm will be taking the Study drug (Dronabinol) one hour prior to bed each night for 6 weeks.	Drug: Dronabinol; 10 mg dose of Dronabinol daily for 6 weeks
Placebo Comparator: Placebo; Patients assigned to the placebo arm will be taking the placebo pill (sugar pill) one hour prior to bed each night for 6 weeks.	Drug: Placebo; 10 mg dose of Placebo daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times subjects complete CPAP therapy	CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night	Baseline
Apnea-hypopnea index (AHI)	Apnea-hypopnea index (AHI) an index used to describe the number of apneas experienced during sleep. It is calculated by (Number of hours of sleep/Number of Apneas or hypopneas). This value will then be graded on a scale from Normal (<5) to Severe (>30).	Day 15, Day 29, and Day 42
International Physical Activity Questionnaire	International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality	Baseline and Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour blood pressure	Blood pressure will be monitored for 24 hours and reported as mm/Hg	Baseline and Day 42
Blood Pressure	Blood Pressure will be reported as mm/Hg	Baseline, Day 22, and Day 42

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Virend Somers, M.D., Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: 25-009764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No