None listed
Conditions
Brief summary
The purpose of this trial is to investigate the effects of nocturnal IHL-42X on apnoea hypopnea index, sleep quality and mood in healthy adults. This will be a 6- week, double-blind, placebo controlled randomised trial in patients with suspected or diagnosed mild to moderate Obstructive Sleep Apnoea (OSA) with 3 visits in total (V0, V1 and V2). It is hypothesised that the active treatment will reduce AHI, improve mood and improve well-being after 6 weeks supplementation compared to placebo.
Interventions
The active treatment contains a novel formulation of 10mg of a synthetic (-) -trans-delta-9-tetrahydrocannabinol (THC) with 200mg mineral supplement combination.
The blinded study treatment will be provided as capsules in coded blister packs labelled with the expiry date, contact details for the Principal Investigator, as well as storage and administration instructions. Participants will be instructed to self-administer two capsules by mouth, 60 minutes before bedtime for each night of the stud
The active treatment contains a novel formulation of 10mg of a synthetic (-) -trans-delta-9-tetrahydrocannabinol (THC) with 200mg mineral supplement combination. The blinded study treatment will be provided as capsules in coded blister packs labelled with the expiry date, contact details for the Principal Investigator, as well as storage and administration instructions. Participants will be instructed to self-administer two capsules by mouth, 60 minutes before bedtime for each night of the study duration (5-10 days for phase 1, 42 days for phase 2). After eligibility is verified post- V1 the participants will be supplied with the 6 weeks supply of the treatment, with the blister packs grouped into 14 days’ supply, each with 4 reserve doses to allow for ± 2 day window each week to replace lost or damaged dose units. Participants will be required to return all unused study medication and blister packs at V2, as well as the treatment compliance log which they will be instructed to complete daily. Treatment adherence will also be checked at the three telephone interviews that will take place between V1 and V2 (days 10, 20 and 30). Both the active treatment and the placebo are identical in appearance. Treatments will be provided as capsules in blister packs with the participant identification number and contact details for the principal investigator, clearly labelled by a disinterested third party. Until dispensed to the participants, the trial products will be stored in a securely locked, refrigerated area, only accessible to authorized personnel.
Sponsors
Cannvalate
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, 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 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
Outcome results
None listed