The CANabidiol Use for RElief of Short Term Insomnia (NCT05253417) | Clinical Trial Compass
CompletedPhase 2
The CANabidiol Use for RElief of Short Term Insomnia
Australia208 participantsStarted 2022-05-01
Plain-language summary
This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia symptoms.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and females aged 18-65 years old, inclusive.
✓. Females must be non-pregnant, non-lactating.
✓. Proficient in English and have internet access and a mobile phone.
✓. Insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8 - 21 and have experienced these symptoms over the past month at pre-screening.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Provision of signed and dated informed consent form.
✓. All male and females of childbearing potential must agree to use two forms of effective contraception from the time of signing informed consent until 30 days after study completion.
Exclusion criteria
✕. Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.
✕. The use of any drug known to affect sleep during the study one week prior the randomization, including:
To investigate the effect of the administration of a 50mg and 100mg per day oral CBD product versus placebo over 8 weeks on insomnia severity index scores
✕. Excessive caffeine use (defined as \> 600mg caffeine or approximately 6 cups of caffeinated beverages a day) that, in the opinion of the medical doctor, contributes to the participant's insomnia.
✕. Excessive alcohol use (defined as per NHMRC guideline, i.e. no more than four standard drinks per day on average for men, and for women, no more than two).
✕. The use of cannabinoids or a cannabinoid-based medicine within 3 months prior to study Day 1 and unwillingness to abstain from recreational drug use during the study period.