Dronabinol for Sleep Apnea

(DROSA Trial)

Overseen By Karen M Lenehan

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: VA Office of Research and Development

Must not be taking: Sedative-hypnotics, Antidepressants, Antipsychotics

Disqualifiers: Obesity, Alcohol use, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

120 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot use sedative-hypnotic medications within 30 days of enrollment. Also, you should not start new antidepressant or antipsychotic medications within 3 months before the trial.

What data supports the effectiveness of the drug dronabinol for sleep apnea?

Research suggests that dronabinol, a form of THC, may help reduce sleep-disordered breathing in people with obstructive sleep apnea by stabilizing autonomic output during sleep. Initial findings from clinical trials indicate that dronabinol could be a promising treatment for this condition. ^{1 2 3 4 5}

Is dronabinol safe for humans?

Dronabinol is generally considered safe for humans, with common side effects including dry mouth, dizziness, and headache, which are usually mild to moderate and temporary. More studies are needed to fully understand its side effect profile, but current data suggest that the benefits may outweigh these risks. ^{1 2 3 4 6}

How is the drug dronabinol unique for treating sleep apnea?

Dronabinol is unique for treating sleep apnea because it works by activating cannabinoid receptors, which can stabilize breathing during sleep, unlike other treatments that primarily focus on mechanical airway support. Additionally, there are currently no approved drug treatments for obstructive sleep apnea, making dronabinol a novel option being explored in clinical trials. ^{1 2 4 5 7}

What is the purpose of this 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.

Research Team

Bharati Prasad, MD

Principal Investigator

Jesse Brown VA Medical Center, Chicago, IL

Eligibility Criteria

This trial is for individuals with obstructive sleep apnea (OSA). Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis of OSA and be in stable health to participate.

Inclusion Criteria

AHI 15-50 per hour on pre-treatment polysomnography

Exclusion Criteria

Active enrollment in a weight loss program

I have had surgery for sleep apnea, not including adenotonsillectomy.

My weight has been stable for 6 months after bariatric surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label Dronabinol treatment for two weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dronabinol

Trial Overview The trial is testing the effectiveness of Dronabinol, an oral medication, in treating OSA. It's an open-label study where all participants will receive the drug for two weeks with sleep studies before and after treatment to assess changes.

Participant Groups

Group I: Single group Experimental Treatment 1 Intervention

Open label Dronabinol treatment for two weeks.

Dronabinol is already approved in United States, Canada for the following indications:

Approved in United States as Marinol for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting
• Sleep apnea

Approved in United States as Syndros for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Approved in Canada as REDUVO for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Findings from Research

In a Phase II trial involving 73 adults with moderate to severe obstructive sleep apnea (OSA), dronabinol significantly reduced the apnea-hypopnea index (AHI) by up to 12.9 events/hour compared to placebo, indicating its potential efficacy as a treatment.

Participants taking 10 mg of dronabinol reported greater satisfaction with their treatment and experienced a significant reduction in daytime sleepiness, as measured by the Epworth Sleepiness Scale, suggesting that dronabinol may improve both sleep quality and overall well-being in OSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea. Carley, DW., Prasad, B., Reid, KJ., et al.[2019]

In a proof-of-concept study involving 17 adults with Obstructive Sleep Apnea (OSA), dronabinol (Δ(9)THC) was found to be safe and well-tolerated at doses ranging from 2.5 to 10 mg daily.

Dronabinol significantly reduced the Apnea Hypopnea Index (AHI) by an average of 14.1 events per hour after 21 days of treatment, indicating its potential efficacy in managing OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proof of concept trial of dronabinol in obstructive sleep apnea. Prasad, B., Radulovacki, MG., Carley, DW.[2021]

In a meta-analysis of 16 trials, nabilone was associated with significantly higher rates of drowsiness, dizziness, and dry mouth compared to placebo, indicating a notable risk of these side effects.

Dronabinol also showed increased occurrences of dry mouth, dizziness, and headache compared to placebo, but the overall severity of adverse events was generally mild-to-moderate, suggesting that the benefits may outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. Bajtel, Á., Kiss, T., Tóth, B., et al.[2022]

The FDA approved Syndros, an oral solution containing dronabinol (delta-9-THC), on July 1, 2016, indicating its recognized therapeutic potential.

Following FDA approval, the DEA classified Syndros as a Schedule II controlled substance, reflecting its potential for abuse but also its accepted medical use in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments. [2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Proof of concept trial of dronabinol in obstructive sleep apnea. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Safety of Dronabinol and Nabilone: A Systematic Review and Meta-Analysis of Clinical Trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The combination of atomoxetine and dronabinol for the treatment of obstructive sleep apnea: a dose-escalating, open-label trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Cannabinoid Agonists and Antagonists on Sleep and Breathing in Sprague-Dawley Rats. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments. [2017]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Bioavailability study of dronabinol oral solution versus dronabinol capsules in healthy volunteers. [2020]