None listed
Conditions
Brief summary
This is a randomised crossover study to determine the therapeutic benefit of a combination of dronabinol and acetazolamide in subjects with suspected or diagnosed mild to moderate Obstructive Sleep Apnoea (OSA). Subjects will be required to undergo five sleep tests. Prior to each sleep test the Subjects will complete questionnaires to assess daytime somnolence, mood and quality of life. The first sleep test will confirm OSA and establish baseline levels for AHI, daytime somnolence, mood and quality of life. Once OSA is confirmed Subjects will be randomised into one of six treatment arms. All Subjects will undergo four treatment periods where they will receive treatment one of placebo or low, medium or high dose combination of dronabinol with acetazolamide. All subjects will receive all treatments over the course of the study but the order or treatment periods will be random. Each treatment will last for seven nights with a seven-night washout period between treatments. On night 7 of each treatment period the Subjects will undergo a sleep study using a polysomnography (PSG) machine at the sleep clinic. Sleepiness, mood and quality of life questionnaires with completed prior to PSG set up on night 7. AHI, daytime somnolence, mood and quality of life scores will be compared to baseline across the 4 treatments to establish the optimal dose for the therapeutic benefit for the combination of dronabinol with acetazolamide for treatment of OSA.
Interventions
This study will determine the therapeutic benefit of a combination of dronabinol and acetazolamide at reducing AHI in adults with obstructive sleep apnoea. Investigational product will be administered by mouth as two separate gel capsules. The first dose will be administered at the study site on the afternoon of day one of the treatment period. For the next six nights the dose will be administered approximately 60 min before bedtime each night. There are a total of seven doses, one per day, over
This study will determine the therapeutic benefit of a combination of dronabinol and acetazolamide at reducing AHI in adults with obstructive sleep apnoea. Investigational product will be administered by mouth as two separate gel capsules. The first dose will be administered at the study site on the afternoon of day one of the treatment period. For the next six nights the dose will be administered approximately 60 min before bedtime each night. There are a total of seven doses, one per day, over a seven day treatment period. The study will consist of four treatment periods. Three doses, low (2.5 mg dronabinol 125 mg acetazolamide) medium (5 mg dronabinol 250 mg acetazolamide) and high (10 mg dronabinol 500 mg acetazolamide) and a placebo will be compared in this study to identify the dose with the best therapeutic benefit and least side effects. This is a cross-over trial where all patients will receive all of the treatments. Each treatment will be administered for one seven-day treatment period. Treatment periods will be separated by seven-day washout periods. The study will consist of four treatment periods and four washout periods for 56 days total. Participants will be provided with a blister pack containing the investigational product at the start of each treatment period. Each blister will contain a single dose, one dronabinol and one acetazolamide gel capsule (or matched placebo), of the investigational product. Treatment adherence will be monitored through a self-reporting treatment administration log and return of blister packs to the study team at the end of each treatment period.
Sponsors
Incannex Healthcare Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Aged between 21 and 65 years - Evidence of OSA based on AHI greater than or equal to 15. The first PSG study will be analysed within 2 business days to confirm AHI criteria. - No known allergic reaction to cannabis products with previous use (self-disclosure). - No known allergic reaction to sesame oil (dronabinol is formulated in sesame oil) - No know allergic reaction to acetazolamide or other sulphonamides. - Have no history of past substance abuse or current abuse of illicit drugs - Physically well, in the opinion of the investigator, with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders - If male, agree to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from study Visit 1 through to the end of the study. Subjects must agree to use two approved methods of contraception for 10 days following the last administration of the study drug, and not donate sperm during this same period of time. In the event that the sexual partner is surgically sterile, contraception is not necessary. - Females of non-childbearing potential with serum FSH levels greater than 40mlU/ml are either postmenopausal or have undergone one of the following sterilization procedures at least 6 months prior to Visit 1; o Bilateral tubal ligation o Hysterectomy o Hysterectomy with unilateral or bilateral oophorectomy o Bilateral oophorectomy - Females of childbearing potential that are not currently pregnant or lactating - Not taken any vitamins, herbal remedies or supplements within 5 days of admission - Voluntarily consent to participate in the study and complete all study required tasks, as instructed by the protocol, including the completion of questionnaires and logs - Willing to abstain from driving a vehicle during the treatment periods plus 2 days after (4 x 9 days) - Willing and able to self-administer two capsules by mouth, at the clinic visit or 60 minutes before bedtime, each night during the treatment periods of the study (4 x 7 days)
Exclusion criteria
-Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.) - Currently using CPAP, or other treatment for OSA including mandibular advancement splint, or positional device - Severe blood O2 desaturation as measured in V1 PSG. - Body Mass Index (BMI) greater than 45 - ESS less than 7 (excludes non-sleepy participants) -History of known hypokalmia (low blood potassium), hyponatremia (low blood sodium), hypocholremic acidosis, adrenal insufficiency, impaired kidney function, marked liver disease or impaired liver function, within the last 6 months.
Outcome results
None listed