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Not yet recruiting NCT07570953

A Study Of Synthetic THC And Sleep

Phase II / Phase III Interventional Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dronabinol, Placebo.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea. Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Dronabinol
    10 mg dose of Dronabinol daily for 6 weeks
  • Drug Placebo
    10 mg dose of Placebo daily for 6 weeks

Primary outcome measures

  • Number of times subjects complete CPAP therapy [Time frame: Baseline]
  • Apnea-hypopnea index (AHI) [Time frame: Day 15, Day 29, and Day 42]
  • International Physical Activity Questionnaire [Time frame: Baseline and Day 42]
Secondary outcome measures (2)
  • 24-hour blood pressure [Time frame: Baseline and Day 42]
  • Blood Pressure [Time frame: Baseline, Day 22, and Day 42]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07570953 · 25-009764

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗