Obstructive Sleep ApneaPhase 1/2DROSANCT06477952
DRonabinol Treatment of OSA
A Phase 1/2 study testing Dronabinol in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 31 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. AHI 15-50 per hour on pre-treatment polysomnography
Who cannot join
- 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
- 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
- History of upper airway surgery for OSA (except adenotonsillectomy)
- 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)
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- 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
- 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
- Current drug or habitual alcohol use or positive urine drug screen
- 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)
- Use of sedative-hypnotic medications within 30 days of enrollment
- Complete blood count or liver function test values more than 1.5 times the upper limit of normal
- Pregnancy
- Allergy to cannabinoids or sesame oil
- Average weekly alcohol consumption of more than 10 servings
- Participation in other investigational protocols within 30 days of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Karen M Lenehan, (312) 569-6343, Karen.Lenehan@va.gov
Howard S Gordon, MD BS, (312) 569-7331, howard.gordon2@va.gov
About this study
Official title: Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial
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.
Read the detailed description
Obstructive sleep apnea (OSA), is a serious respiratory disorder that involves repetitive cessation of breathing during sleep. It is estimated that 15-20 million people in the United States suffer from OSAS, which has been linked to increased risk for hypertension, heart failure, depression, and diabetes. The current standard of care for OSA, positive airway pressure (PAP), involves a mechanical device with low patient tolerance and adherence. Upper airway surgical approaches are also an option but are invasive and often unsuccessful. Effective drug treatments for OSA remain to be identified.
This study will enroll up to 120 Veterans so that 45 Veterans may complete the two-week open-label Dronabinol treatment trials. The results of the study will be used to develop a prediction model for OSA severity reduction after 2-week Dronabinol treatment vs. pretreatment AHI. Participants clinical (age, sex, body mass index, comorbidity) and pretreatment polysomnographic characteristics (sleep architecture, respiratory disturbance, and endotypes; loop-gain, arousal threshold, upper airway collapsibility and compensation) will be used to develop a prediction model for improvement of OSA with Dronabinol treatment. This prediction model will be used for a randomized clinical trial after the completion of this trial.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Dronabinol
- Keywords
- OSA, sleep apnea, pharmacological treatment, Drug treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol
Open label Dronabinol treatment for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Open label Dronabinol treatment for two weeks. Receives: Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
The change in AHI after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms.
Measured: 2 weeks
Secondary outcomes (1)
T<90
The change in time below 90% oxygen saturation (T<90) after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start25 Aug 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 120 Veterans will be screened and enrolled to achieve 45 participants completing the study. All participants will receive oral Dronabinol treatment nightly for two weeks.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Illinois Chicago
- Responsible party
- Sponsor
- Investigators
- Bharati Prasad, MD, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477952
- Sponsor's protocol ID
- PULM-011-23F
- Other IDs
- 5I01CX002632-02
- Acronym
- DROSA
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06477952
- Acronym / sponsor ID
- DROSA / PULM-011-23F
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, sleep apnea, pharmacological treatment, Drug treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Illinois Chicago
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstructive sleep apnea (OSA), is a serious respiratory disorder that involves repetitive cessation of breathing during sleep. It is estimated that 15-20 million people in the United States suffer from OSAS, which has been linked to increased risk for hypertension, heart failure, depression, and diabetes. The current standard of care for OSA, positive airway pressure (PAP), involves a mechanical device with low patient tolerance and adherence. Upper airway surgical approaches are also an option but are invasive and often unsuccessful. Effective drug treatments for OSA remain to be identified.
This study will enroll up to 120 Veterans so that 45 Veterans may complete the two-week open-label Dronabinol treatment trials. The results of the study will be used to develop a prediction model for OSA severity reduction after 2-week Dronabinol treatment vs. pretreatment AHI. Participants clinical (age, sex, body mass index, comorbidity) and pretreatment polysomnographic characteristics (sleep architecture, respiratory disturbance, and endotypes; loop-gain, arousal threshold, upper airway collapsibility and compensation) will be used to develop a prediction model for improvement of OSA with Dronabinol treatment. This prediction model will be used for a randomized clinical trial after the completion of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 120 Veterans will be screened and enrolled to achieve 45 participants completing the study. All participants will receive oral Dronabinol treatment nightly for two weeks.
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Drug: DronabinolOpen label Dronabinol treatment for two weeks. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. AHI 15-50 per hour on pre-treatment polysomnography
Key exclusion criteria (24 listed)
- 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
- 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
- History of upper airway surgery for OSA (except adenotonsillectomy)
- Central or mixed apneas >25% of respiratory events on diagnostic polysomnography
- Arterial oxygen saturation < 75% for > 5% sleep time on pretreatment polysomnography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: MarinolOpen label Dronabinol treatment for two weeks. | Drug | Single group |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 2 weeks
The change in AHI after two weeks of Dronabinol treatment will be determined from before and after treatment polysomnograms.
1 secondary outcome
T<90
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bharati Prasad, MD principal investigator
Jesse Brown VA Medical Center, Chicago, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dronabinol in people with Obstructive Sleep Apnea, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bharati Prasad, MD ((312) 996-8433, bharati.prasad@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.