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Taking people in United StatesPhase 1/2

Dronabinol as a possible treatment for obstructive sleep apnea

Tests dronabinol taken by mouth in people with obstructive sleep apnea.

Key facts

Who runs it
VA Office of Research and Development
Where
Chicago, United StatesSee the site
Trial code
Registry title
DRonabinol Treatment of OSA
Status
Recruiting
Phase
Phase 1/2
People taking part
120 people, planned
Started
25 Aug 2025
Expected to end
31 Mar 2027
Type of study
Interventional
Treatments tested
  • Dronabinol
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obstructive sleep apnea (breathing stops during sleep because the airway closes). Everyone takes Dronabinol by mouth for two weeks.

Age
Up to 65 Years.
Sex
All sexes can join.
Disease stage
Obstructive sleep apnea with an AHI (breathing pauses per hour) of 15-50 per hour on a sleep study before treatment.
Earlier treatment
People who used PAP, a hypoglossal nerve stimulator or an oral appliance more than 4 hours per day on 30% of days in the last 3 months cannot join. People who had upper airway surgery for OSA cannot join, except removal of tonsils and adenoids.

Main reasons for not taking part

  • Body mass index over 45 kg/m2, or active weight loss program.
  • Shift work, commercial driver or pilot job, or a car accident or near-miss in the last year.
  • Drug use, heavy alcohol use, a positive urine drug test, or sedative sleep medicines in the last 30 days.
  • Pregnancy, or allergy to cannabinoids or sesame oil.
  • Other sleep disorders, uncontrolled heart, lung, liver, kidney or mood disorders, schizophrenia, or high suicide risk.

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • AHI 15-50 per hour on pre-treatment polysomnography

Who cannot take part

  • Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use > 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report
  • If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug
  • Current drug or habitual alcohol use or positive urine drug screen
  • Use of sedative-hypnotic medications within 30 days of enrollment
  • History of upper airway surgery for OSA (except adenotonsillectomy)
  • Comorbid medical and psychiatric disorders:; Primary sleep disorders: e.g., narcolepsy, restless legs syndrome; Uncontrolled mood disorder or a diagnosis of schizophrenia; Initiation of new antidepressant or antipsychotic medication within 3 months; Identified as high-risk for suicide in electronic health records; Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestive heart failure, chronic obstructive pulmonary disease, chronic hypoxemic or hypercapnic respiratory failure, stroke within 6 months of enrollment, chronic liver or kidney disease, autoimmune disorders)
  • Allergy to cannabinoids or sesame oil
  • Complete blood count or liver function test values more than 1.5 times the upper limit of normal
  • Positive Airway Pressure (PAP) treatment of obstructive sleep apnea (OSA): use > 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data
  • Central or mixed apneas >25% of respiratory events on diagnostic polysomnography
  • Arterial oxygen saturation < 75% for > 5% sleep time on pretreatment polysomnography
  • Body mass index > 45 kilograms per square meter (kg/m2)
  • Active enrollment in a weight loss program
  • Shiftwork within 3 months of enrollment
  • High-risk occupation: commercial driver and pilot
  • Motor vehicle accident or near-miss incident within 1 year of enrollment
  • Pregnancy
  • Average weekly alcohol consumption of more than 10 servings
  • Participation in other investigational protocols within 30 days of enrollment

Where in United States

  • Jesse Brown VA Medical Center, Chicago, ILChicago, United StatesContact: Karen M LenehanTaking people

About the trial

What the trial wants to find out

This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.

The group in the trial

  • Single groupTreatment being tested

    Open label Dronabinol treatment for two weeks.

    Treatment: Dronabinol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial
Plain-language title
Dronabinol as a possible treatment for obstructive sleep apneaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
5 November 2026