DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
DReAMzz
Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea
1 other identifier
interventional
120
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2026
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 3, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
June 9, 2026
June 1, 2026
10 months
June 3, 2026
June 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in AHI4 at the end of each treatment period compared to baseline
To assess the change in efficacy at the end of each dosing period compared with baseline.
Each treatment period (28 days)
Secondary Outcomes (14)
Percent change in AHI4 at the end of each treatment period compared to baseline
Each treatment period (28 days)
Change in Functional Outcomes of Sleep Questionnaire 10-items (FOSQ-10) at the end of each treatment period compared to baseline
Each treatment period (28 days)
Change in Patient-reported outcome measurement information system (PROMIS)-Fatigue 7a at the end of each treatment period compared to baseline
Each treatment period (28 days)
Change in Patient-reported outcome measurement information system - Sleep Related Impairment (PROMIS-SRI) 8a at the end of each treatment period compared to baseline
Each treatment period (28 days)
Change in Patient Global Impression of Severity (PGI-S) the end of each treatment period compared to baseline
Each treatment period (28 days)
- +9 more secondary outcomes
Study Arms (10)
IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
EXPERIMENTALIHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
EXPERIMENTALIHL-42X (5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
EXPERIMENTALIHL-42X (7.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
EXPERIMENTALIHL-42X (2.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
EXPERIMENTALIHL-42X (5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
EXPERIMENTALIHL-42X (7.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
EXPERIMENTALIHL-42X (2.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
EXPERIMENTALIHL-42X (5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
EXPERIMENTALIHL-42X (7.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
Placebo: Negative control
PLACEBO COMPARATOROne capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks
Interventions
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
Eligibility Criteria
You may qualify if:
- Participants must satisfy all the following criteria at screening unless otherwise stated:
- Aged ≥18 and ≤65 years of age at the time of consent.
- Two screening PSG findings confirmed on central over-read that both must meet the below criteria:
- AHI4 ≥5
- ≤25% central or mixed apneas out of total AHI
- no Cheyne-Stokes respiration
- total sleep time ≥ 4 hours in each PSG
- \< 30 periodic leg movement disorder arousals per hour.
- A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2.
- A PROMIS-SRI 8a score of \>16.
- Intolerant or non-compliant to PAP, or has refused PAP after physician recommendation. Participants will be identified as intolerant or non-compliant to PAP devices by the following criteria (NB: OSA diagnosis must be entered in participant medical history):
- Participants are regarded as PAP-non-compliant if they do not use PAP for ≥ 4 hours for at least 63 nights during consecutive 90-day period based on data collected from the PAP device (e.g., SD storage cards) and/or a cloud-based repository of PAP device data.
- Participants are regarded as PAP-intolerant if they are former PAP users, i.e., a PAP device that they have not used for \>90 days, have tried PAP and not continued to use it or refusal of PAP after prior positive sleep study or prior refusal of provider recommended sleep study due to unwillingness to consider PAP.
- NB: Participants will have the benefits and risks of PAP explained at screening, including that PAP is standard of care for OSA. Participants also have the option to withdraw from the study at any time if he/she elects to be treated with PAP or other alternative therapy such as an oral appliance or surgery.
- Must agree not to take any form of cannabis or cannabinoid with the exception of the IP, or any other illicit or recreational drug while participating in this study.
- +11 more criteria
You may not qualify if:
- Participants will be excluded from the study if they satisfy any of the following criteria at screening, unless otherwise stated:
- Body mass index (BMI) \>40 kg/m2 (men) and \>42 kg/m2 (women).
- Diagnosed obesity hypoventilation syndrome or hypercapnia.
- PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.
- Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.
- Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment.
- Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.
- Use of benzodiazepines, sedative-hypnotics or stimulants (Anatomical Therapeutic Chemical \[ATC\] N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, and other sleep disorders, or other disorders that require the drug to be taken prior to sleep.
- Use of other prescription medications to treat insomnia.
- Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Known allergic or other severe reaction to cannabis products with previous use.
- Known allergic reaction to sesame oil.
- Known allergic reaction to acetazolamide.
- Pregnant or breastfeeding.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Exalt Clinical Research
Chula Vista, California, 91910, United States
Teradan Clinical Trials LLC
Brandon, Florida, 33511, United States
CNS Healthcare - Jacksonville
Jacksonville, Florida, 32256, United States
CNS Healthcare Orlando
Orlando, Florida, 32801, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Conquest Research/Neurotrials
Winter Park, Florida, 32789, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621, United States
CNS Healthcare - Memphis
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
Sleep Therapy & Research Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2026
First Posted
June 9, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06