The effects of novel medicinal cannabis formulation IHL-42X on apnoea hypopnea index in adults with suspected or diagnosed mild to moderate obstructive sleep apnoea.

Phase 2

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12619001103156
• Lead Sponsor: Cannvalate

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Aged between 21 and 65 years
•Evidence of an Apnoea Hypopnea Index greater than or equal to 15 or less than or equal to 50. This criteria will be subject to the potential participant either being recently referred to the Austin sleep laboratory for ‘likely OSA’ or having a pre-existing diagnosis of OSA from a physician. This will be verified by the results of the PSG post V1, before randomisation occurs.
•Have experimented with cannabinoids previously (self-disclosure). This includes any cannabis product (marijuana, skunk, ‘weed’)
•No known allergic reaction to cannabis products with previous use
•Ability to speak and read English
•Have no history of past substance abuse or current abuse of illicit drugs
•Physically well with no severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders
•Not currently pregnant or lactating
•Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne).
•Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
•Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
•Willing to abstain from driving a vehicle for the duration of the study (minimum 6 weeks)
•Willing to self-administer two capsules by mouth, 60 minutes before bedtime, each night for the duration of the study
•Willing to complete a drug-administration log daily throughout participation
•Willing to undergo three phone interviews throughout the duration of the study

Exclusion Criteria

•Aged under 21 or over 65 years
•AHI of under 15 or over 50, or no doctors referral or diagnosis of sleep disorder
•Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.)
•Currently using a positive airway pressure device (e.g. CPAP, VPAP), or other treatment for OSA including mandibular advancement splint, or positional device
•BMI > 45
•ESS < 7 (excludes non-sleepy participants)
•Inability to speak or read English
•Non-compliance with study treatment following placebo run-in (missing greater than 20% of the treatment doses)
•History of drug or substance abuse or current illicit drug abuse
•Not physically well, or a history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders
•Currently pregnant or breastfeeding
•Currently taking medication (except for prophylactic antibiotics, contraceptive pill or other routine medications to treat benign conditions, such as antibiotics to treat acne)
•Severe depression (a cut off of 20 and higher on the BDI)
•Severe anxiety (a cut off of 16 and higher on the BAI).
•No previous experience with cannabinoids
•Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified