Obstructive Sleep Apnea (OSA)Phase 2DReAMzzNCT07635563

DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.

A Phase 2 study testing IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide and IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide in people with Obstructive Sleep Apnea (OSA), run by Incannex Healthcare Ltd at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obstructive Sleep Apnea (OSA)
What is being tested?: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide and IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 13 sitesUnited States
Study dates: 21 Jul 2026to May 2027
Phase: Phase 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.
A female participant of childbearing potential must agree to at least one approved highly effective method of contraception. Approved methods of contraception include the following:
Intra-uterine device in place for at least 3 months prior to Day 1 through to 10 days following the last dose of the study drug.
Stable hormonal contraceptive which includes oral, intravaginal, intrauterine, transdermal, injectable, or implantable methods of hormonal contraception for at least 3 months prior to Day 1 through to 10 days after the last dose of the study drug.
NB: Barrier method (condom or diaphragm) is not considered 'highly effective' for the purpose of this study and should be used in combination with one of the approved highly effective methods listed above.
A female will not be considered of childbearing potential if:
12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/ml.
Undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to Day 1.
A male participant must agree to use at least 1 approved method of contraception (or as required by local regulations) while engaging in sexual activity from study Day -1 through EOS follow-up and/or up to 10 days following the last administration of the study drug. Male participants must not donate sperm during this same period. Approved methods of contraception include the following:
Barrier method (condom) from date of consent through to 10 days after the final dose of the study drug.
Surgical sterilization (vasectomy) at least 6 months prior to Day 1 with proof of azoospermia.
Voluntarily written consent to participate in the study and be willing and able to participate in all scheduled visits, treatment plans, tests, and other study procedures according to the protocol.

Who cannot join

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.

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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.
Current illicit drug abuse (within the last 6 months prior to screening); "abuse" has some subsets that are objective and some that require investigator judgement; questions should be discussed with the medical monitor or with the sponsor
An objective subset includes consumption of substances that are "illicit", i.e., not legal per local laws
Investigator judgement is expected for legally marketed products ingested for other than the approved indication(s)
Participants who test positive to THC should be screen failed and can be considered for rescreening after a >6-week washout period. Participants can only be rescreened once. Positive test results for all other substances shall be reviewed by the investigator and participants shall only be screen failed if the investigator believes the use of the substance may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings.
Severe depression, defined as a score of ≥30 on the Major Depression Inventory (MDI) questionnaire.
Severe anxiety, defined as score of >15 on the General Anxiety Disorder-7 (GAD-7) questionnaire.
Any of the following co-morbid conditions (NB: clarification on co-morbidities and inclusion/exclusion criteria may be discussed with the medical monitor and/or sponsor):
Severe psychiatric disorder that might be aggravated or exacerbated by dronabinol's potential to cause anxiety/nervousness, depersonalization, hallucination, etc.
Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
Cardiac dysfunction and/or its treatment that might augment dronabinol's potential to cause tachycardia or vasodilation.
Marked hepatic dysfunction as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), that would reduce dronabinol metabolism.
One retest per participant is permitted at the discretion of the investigator; the participant may continue if BOTH repeat transaminase levels are within acceptable range (i.e., less than 3 × ULN).
Current or history of encephalopathy or cirrhosis Child-Pugh category B or C (see Appendix 8) since acetazolamide can increase blood ammonia levels precipitating a bout of hepatic encephalopathy.
Marked renal dysfunction that would reduce acetazolamide excretion, including eGFR <60 mL/min/1.73 m2, as determined using the National Kidney Foundation calculator (https://www.kidney.org/professionals /kdoqi/gfr_calculator) and instructions in Appendix 9.
Hypokalemia (low blood potassium), hyponatremia (low blood sodium), hyperchloremic acidosis, and/or adrenal insufficiency that might be aggravated or exacerbated by acetazolamide's activity as a carbonic anhydrase inhibitor.
Known CYP2C9 poor metabolizers (NB: this is based on medical history and does not need to be tested genetically).
Other ongoing condition(s) that the investigator considers may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings; any consideration should be discussed with the medical monitor or with the sponsor (such as known alcohol abuse).
Shift workers whose shift pattern has the potential to disrupt sleep patterns.
Participation in any other interventional studies involving investigational or marketed products within 30 days or 5.5 half-lives, whichever is longer, prior to screening.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mark Bleackley contact

Pia Kroner contact

City, postcode or hospital

Sites recruiting now only

13 sites in 1 country

United States13 sites, 13 recruiting

Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Boris Nikolov, 864-965-0190, bnikolov@velocityclinical.com
Charles Thompson
Recruiting
Teradan Clinical Trials LLC
Brandon, Florida, 33511
Fran Poli, 813-603-4496, franp@teradanclinicaltrials.com
Daniel Lorch
Recruiting
Exalt Clinical Research
Chula Vista, California, 91910
Tiffany Hecklinski, PhD, 619-826-8914, tiffany@exaltresearch.com
David Bortz
Recruiting
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Hanna Earley, 513-841-6307, hearley@ctifacts.com
Robert Wagner
Recruiting
Intrepid Research
Cincinnati, Ohio, 45245
Sydnei Simpson, 513-977-8895, ssimpson@intrepidresearch.md
Bruce Corser
Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
Cassandra B Esquibel, 214-369-2600, cassandrab@fstrials.com
Michael Downing
Recruiting
CNS Healthcare - Jacksonville
Jacksonville, Florida, 32256
Niketa Salvi, 904-281-5757, nsalvi@cnshealthcare.com
Mark Joyce
Recruiting
Tandem Clinical Research
Marrero, Louisiana, 70072
Courtney Hargrove, 504-934-8424, CHargrove@tandemclinicalresearch.com
Angela Traylor
Not yet recruiting
CNS Healthcare - Memphis
Memphis, Tennessee, 38119
Carol Marsh, 901-843-1045, cmarsh@cnshealthcare.com
Lora McGill
Recruiting
CNS Healthcare Orlando
Orlando, Florida, 32801
Bridget Miglio, 407-425-5100, bmiglio@cnshealthcare.com
Felipe Suplicy
Recruiting
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Uchenna Ezeanolue, 240-698-2800, uezeanolue@velocityclinical.com
Asefa Mekonnen
Recruiting
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Skyler Edmisten, 726-900-1102, edmisten.skyler@sleeptrc.com
James Andry
Recruiting
Palm Beach Research Center
West Palm Beach, Florida, 33409
Jennifer Butler, 561-689-0606, jennifer@palmbeachresearch.com
Mira Baron
Recruiting

Other trials in United States

About this study

Official title: Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea

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.

Conditions: Obstructive Sleep Apnea (OSA)
Being tested: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide, IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
Keywords: OSA, Obstructive sleep apnea, Obstructive sleep apnoea, CPAP, Cannabinoid, IHL-42X, Incannex, Dronabinol, THC, Aceazolamide, ACZ, AHI, PSG, Polysomnography, PAP, FOS-Q, FOSQ, PROMIS, PGI, ESS
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
IHL-42X: 5 mg dronabinol + 125 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
IHL-42X: 5 mg dronabinol + 250 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
IHL-42X: 5 mg dronabinol + 375 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamideDrug
DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
Placebo: Negative controlDrug
DReAMzz Phase 2 Placebo

Study groups in NCT07635563
Study group	Role	What they receive
IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide	Experimental	IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
IHL-42X: 5 mg dronabinol + 125 mg acetazolamide	Experimental	IHL-42X (5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide	Experimental	IHL-42X (7.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide	Experimental	IHL-42X (2.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
IHL-42X: 5 mg dronabinol + 250 mg acetazolamide	Experimental	IHL-42X (5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide	Experimental	IHL-42X (7.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide	Experimental	IHL-42X (2.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
IHL-42X: 5 mg dronabinol + 375 mg acetazolamide	Experimental	IHL-42X (5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide	Experimental	IHL-42X (7.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. Receives: Drug: IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
Placebo: Negative control	Placebo comparator	One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks Receives: Drug: Placebo: Negative control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Each treatment period (28 days)

Secondary outcomes (14)

Percent change in AHI4 at the end of each treatment period compared to baseline
Measured: 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
Measured: 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
Measured: 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
Measured: Each treatment period (28 days)
Change in Patient Global Impression of Severity (PGI-S) the end of each treatment period compared to baseline
Measured: Each treatment period (28 days)
Patient Global Impression of Change (PGI-C) score at the end of each treatment period compared to baseline
Measured: Each treatment period (28 days)
Change in Patient-reported Longitudinal Assessment Tool for OSA-11 item (PLATO) at the end of each treatment period compared to baseline
Measured: Each treatment period (28 days)
Change in Epworth Sleepiness Scale (ESS) at the end of each treatment period compared to baseline
Measured: Each treatment period (28 days)
Change in Oxygen Desaturation Index (ODI) (from PSG) at the end of each treatment period compared to baseline
Measured: Each treatment period (28 days)
Change in hypoxic burden at the end of each treatment period compared to baseline
Measured: Each treatment period (28 days)
Percent of participants whose OSA severity reduces by one or more levels with severe OSA AHI4 ≥30, moderate OSA AHI4 15-30, mild OSA AHI4 <15
Measured: 140 days
Percent of participants with ≥50% reduction in AHI4
Measured: 140 days
Percent of participants with AHI4 <5
Measured: 140 days
Adverse events and treatment-emergent adverse events (TEAEs), clinically significant out of range values or findings from clinical laboratory test results, electrocardiogram (ECG), vital signs, and physical examinations
To evaluate the safety and tolerability of IHL-42X
Measured: 140 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 2026May 2027

First posted9 Jun 2026
Study start21 Jul 2026
Primary completionApr 2027 (estimated)
Study completionMay 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 Apnea (OSA)Studies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07635563
Sponsor's protocol ID: IHL42XOSAP2X
Acronym: DReAMzz
Status last verified: Oct 2026
First submitted: 3 Jun 2026
Last updated: 13 Oct 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Mark Bleackley

+61 2 9634 4508

mark@incannex.com.au

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
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.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea (OSA) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT07635563
Acronym / sponsor ID: DReAMzz / IHL42XOSAP2X
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: OSA, Obstructive sleep apnea, Obstructive sleep apnoea, CPAP, Cannabinoid, IHL-42X, Incannex, Dronabinol
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: Incannex Healthcare LtdIndustry (pharma, biotech, devices)
Study start: 21 Jul 2026 (actual)
Primary completion: Apr 2027 (estimated)
Study completion: May 2027 (estimated)
First posted: 9 Jun 2026 (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.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide	Experimental	Drug: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 5 mg dronabinol + 125 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 5 mg dronabinol + 250 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 5 mg dronabinol + 375 mg acetazolamideIHL-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	Experimental	Drug: IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamideIHL-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 comparator	Drug: Placebo: Negative controlOne capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

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:
A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2.
A PROMIS-SRI 8a score of >16.

Key exclusion criteria (34 listed)

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.

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
IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 1	Drug	IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
IHL-42X: 5 mg dronabinol + 125 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 2	Drug	IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 3	Drug	IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 4	Drug	IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
IHL-42X: 5 mg dronabinol + 250 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 5	Drug	IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 6	Drug	IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 7	Drug	IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
IHL-42X: 5 mg dronabinol + 375 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 8	Drug	IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamideDReAMzz Phase 2 Investigational Product - IHL-42X Dose 9	Drug	IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
Placebo: Negative controlDReAMzz Phase 2 Placebo	Drug	Placebo: Negative control

Primary outcome

Change in AHI4 at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
To assess the change in efficacy at the end of each dosing period compared with baseline.

14 secondary outcomes

Percent change in AHI4 at the end of each treatment period compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Each treatment period (28 days)
Change in Patient Global Impression of Severity (PGI-S) the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Patient Global Impression of Change (PGI-C) score at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Patient-reported Longitudinal Assessment Tool for OSA-11 item (PLATO) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Epworth Sleepiness Scale (ESS) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in Oxygen Desaturation Index (ODI) (from PSG) at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Change in hypoxic burden at the end of each treatment period compared to baseline
Time frame: Each treatment period (28 days)
Percent of participants whose OSA severity reduces by one or more levels with severe OSA AHI4 ≥30, moderate OSA AHI4 15-30, mild OSA AHI4 <15
Time frame: 140 days
Percent of participants with ≥50% reduction in AHI4
Time frame: 140 days
Percent of participants with AHI4 <5
Time frame: 140 days
Adverse events and treatment-emergent adverse events (TEAEs), clinically significant out of range values or findings from clinical laboratory test results, electrocardiogram (ECG), vital signs, and physical examinations
Time frame: 140 days

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 13 Oct 2026.

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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.

Mark Bleackley contact

Pia Kroner contact

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 26 inclusion and 34 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 Mark Bleackley (+61 2 9634 4508, mark@incannex.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in AHI4 at the end of each treatment period compared to baseline (time frame: Each treatment period (28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635563.

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 13 Oct 2026.