An Open Label Extension on the Examination of the Combination of Dronabinol and Acetazolamide for Treatment of Obstructive Sleep Apnoea (OSA)
- Conditions
- Obstructive Sleep ApnoeaRespiratory - Sleep apnoea
- Registration Number
- ACTRN12621000809831
- Lead Sponsor
- Incannex Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 1
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.
oApproved 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;
oBilateral tubal ligation
oHysterectomy
oHysterectomy with unilateral or bilateral oophorectomy
oBilateral 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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apnoea Hypopnoea Index (AHI) as measured by overnight polysomnography over 6 months treatment with dronabinol and acetazolamide.[Polysomnography (PSG), a total of three at Day 28, Day 84 and Day 168 to assess the Apnoea Hypopnoea Index (AHI) at each of these timepoints. ]
- Secondary Outcome Measures
Name Time Method