Proof of concept study on the combined effect of dronabinol and acetazolamide on apnoea hypopnoea index (AHI) in adults with obstructive sleep apnoea

Phase 2

Completed

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12620000916943
• Lead Sponsor: Incannex Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Study Completion: 2021-12-15
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in apnoea hyponea index (AHI) compared to baseline as assessed by overnight, in-clinic polysomnography.[Night seven of the treatment period]