None listed
Conditions
Brief summary
Participants that have completed all study visits on Linked study: ACTRN 12620000916943, (Dose finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults with obstructive sleep apnoea (OSA)) AND have an overall reduction in the Apnoea Hypopnoea Index (AHI) will be granted the option to participate in the IHLOSAOLE1 study. This will enable participants who had an overall reduction in OSA to continue to take the investigational product for a further 6 months (24 weeks). The participants will complete PSGs at the sleep clinic, Sleepiness, mood and quality of life questionnaires AHI, daytime somnolence, mood and quality of life scores will be compared to baseline to observe if efficacy is maintained over the 6 month period.
Interventions
This study is linked to the IHLOSAPOC1-Dose finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults with obstructive sleep apnoea (OSA);ACTRN126200000916943.
This study will determine the therapeutic benefit of a combination of dronabinol and acetazolamide at reducing AHI in adults with obstructive sleep apnoea over a 6 month period in participants that completed the proof of concept study, IHLOSAPOC1. There is no requi
This study is linked to the IHLOSAPOC1-Dose finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults with obstructive sleep apnoea (OSA);ACTRN126200000916943. This study will determine the therapeutic benefit of a combination of dronabinol and acetazolamide at reducing AHI in adults with obstructive sleep apnoea over a 6 month period in participants that completed the proof of concept study, IHLOSAPOC1. There is no requirement for participants to washout before commencing the open label extension study, once completing the initial proof of concept study. Investigational product will be administered by mouth as two separate capsules. Participants will be provided with a blister pack containing the investigational product at the start of each 28 day period. Each blister will contain a single dose, one dronabinol and one acetazolamide capsule, of the investigational product. Participants will continuously self-administer the investigational product for the entire 6 month period. Participants will collect 28 day pack of investigational product at each clinic visit. There are a total of 28 doses, one per day, over a 28 day treatment period. They will be required to return the used/empty drug pack at each clinic visit to monitor adherance to the daily dosing schedule and for drug compliance review. The doses will be administered approximately 60 min before bedtime each night. The dosing will commence with the lowest dose, as defined in IHLOSAPOC1, low (2.5 mg dronabinol 125 mg acetazolamide). If the drug combination is not effective at reducing the sleep apnoea symptoms in a participant, as determined by the patient reported outcomes and AHI measured at each PSG, the dose may be increased to the medium dose, medium (5 mg dronabinol 250 mg acetazolamide) at the discretion of the investigator. The total treatment period is 24 weeks (6 months).
Sponsors
Incannex Healthcare Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Linked study record ACTRN126200009116943 1.Participants must have completed participation in the IHLOSAPOC1 study (ACTRN126200009116943) and had a reduction in AHI upon treatment with dronabinol and acetazolamide 2.Would benefit from continued treatment with dronabinol and acetazolamide at the discretion of the treating physician and principal investigator 3.No known allergic reaction to cannabis products with previous use 4.No known allergic reaction to sesame (dronabinol is formulated in sesame oi) 5.No known allergy to acetazolamide or other sulphonamides 6.Ability to speak and read English 7.Agree to refrain from driving for the duration of the study 8.Have no history of past substance abuse (within the past 5 years) or current abuse of illicit drugs (within 6 months) other than the dronabinol used in IHLOSAPOC1 9.Physically well, based on the opinion of the investigator, with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders 10.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. o Approved methods of contraception; a. Inter-uterine device (IUD) in place for at least 3 months prior to Day 1 through 10 days following the final dosing of the study drug b. Barrier method (Condom or diaphragm) for at least 14 days prior to Visit 1 through to 10 days following the last administration of the study drug. c. Stable hormonal contraceptive for at least 3 months prior to Visit 1 and barrier method (condom or diaphragm) for at least 14 days prior to Visit 1 through to 10 days following the last administration of the study drug. d. Surgical sterilization (vasectomy) at least 6 months prior to Visit 1. Females of non-childbearing potential who have established serum FSH levels >40mlU/ml (i.e. determined prior to this study and not an assessment performed as part of this study) 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 11. Females of childbearing potential that are not currently pregnant or lactating 12. Not taking any vitamins, herbal remedies or supplements within 5 days of admission 13. Voluntarily consent to participate in the study and complete all study required tasks, as instructed by the protocol, including the completion of questionnaires and diaries 14. High (>15) score on the Epworth Sleepiness Scale 15. Willing and able to self-administer two capsules by mouth, 60 minutes before bedtime, each night for the duration of the trial (24 weeks).
Exclusion criteria
Linked study record ACTRN126200009116943 1. AHI of < 15 2. Diagnosis of sleep disorder other than sleep apnoea (e.g. restless legs syndrome, narcolepsy, parasomnias etc.) 3. Currently using a positive airway pressure device (e.g. CPAP, VPAP), or other treatment for OSA including mandibular advancement splint, or positional device 4. BMI > 45 5. ESS < 7 (excludes non-sleepy participants) 6. Inability to speak or read English 7. Pregnant or breast-feeding 8. History of drug or substance abuse (within the last 5 years) or current illicit drug abuse (with in the last 6 months) 9. Not physically well, or a history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders 10. Currently taking medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne) 11. History of known conditions to include the following; hypokalemia (low blood potassium), hyponatremia (low blood sodium), hypochloremia acidosis, adrenal insufficiency, impaired kidney function, marked liver disease or impaired liver function or abnormal blood cell counts, within the last 6 months. 12. Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit with the exception of the proof-of-concept study IHLOSAPOC1 (Linked study record ACTRN126200009116943) 13. If there are any additional concerns about the subject’s safety or well-being as a result of participating in the trial, subjects can be excluded at the treating physician’s discretion.
Outcome results
None listed