DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea. (NCT07635563)
Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea
🩺 Plain-English Summary (8th-Grade Level)
The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.
Who can join: Review the eligibility criteria below.
Location: Exalt Clinical Research — Chula Vista, California
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
- IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide (DRUG)
- IHL-42X: 5 mg dronabinol + 125 mg acetazolamide (DRUG)
- IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide (DRUG)
- IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide (DRUG)
- IHL-42X: 5 mg dronabinol + 250 mg acetazolamide (DRUG)
- IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide (DRUG)
- IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide (DRUG)
- IHL-42X: 5 mg dronabinol + 375 mg acetazolamide (DRUG)
- IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide (DRUG)
- Placebo: Negative control (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Exalt Clinical Research — Chula Vista, California
- Teradan Clinical Trials LLC — Brandon, Florida
- CNS Healthcare - Jacksonville — Jacksonville, Florida
- CNS Healthcare Orlando — Orlando, Florida
- Palm Beach Research Center — West Palm Beach, Florida
- Conquest Research/Neurotrials — Winter Park, Florida
- Tandem Clinical Research — Marrero, Louisiana
- Velocity Clinical Research, Rockville — Rockville, Maryland
- CTI Clinical Research Center — Cincinnati, Ohio
- Intrepid Research — Cincinnati, Ohio
- Velocity Clinical Research, Anderson — Anderson, South Carolina
- CNS Healthcare - Memphis — Memphis, Tennessee
- FutureSearch Trials of Dallas — Dallas, Texas
- Sleep Therapy & Research Center — San Antonio, Texas
📞 Contact the Study Coordinator
Phone: +61 2 9634 4508
Email: mark@incannex.com.au
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Obstructive Sleep Apnea (OSA)
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- Assessing the Validity of the PAP Problems Triage Tool in Patients With PAP Treatment for Obstructive Sleep Apnea — Fontana, California
- Overnight Polysomnography and Respiratory Volume Monitor — Boston, Massachusetts
- CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children — Toronto, Ontario
- CPAP Randomized Controlled Trial — Toronto, Ontario
- A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults — Tucson, Arizona
Explore by condition: All Obstructive Sleep Apnea (OSA) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.