Status:
COMPLETED
The CANabidiol Use for RElief of Short Term Insomnia
Lead Sponsor:
Bod Australia
Collaborating Sponsors:
Woolcock Institute of Medical Research
Conditions:
Sleep Disturbance
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a double-blind, randomised, parallel-group, placebo-controlled study of 8 weeks of oral CBD at 50 or 100 mg per day versus placebo in 198 participants with insomnia symptoms as classified by a...
Eligibility Criteria
Inclusion
- 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
- 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:
- Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate, sedating antidepressants, sedating antihistamines, antipsychotics, melatonin, valerian).
- Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).
- Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).
- 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.
- Cannabis dependence or any other drug or alcohol dependence within the past two years.
- Positive urine drug screen (e.g., amphetamines type substances, benzodiazepines, cannabinoids, cocaine, and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.
- Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.
- Use of any investigational drug or involvement in another clinical trial within 30 days of screening day.
- Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.
- Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT) and CNS-active drugs).
- Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported sleep disorders.
- Medical conditions that result in frequent sleep disturbance (e.g. nocturia).
- History of attempted suicide in the past 12 months.
- Clinically significant hepatic abnormalities determined by the screening blood test.
- Shift work, jet lag or trans-meridian travel (two time zones) in the past month.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT05253417
Start Date
May 1 2022
End Date
July 7 2023
Last Update
August 16 2023
Active Locations (2)
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1
Woolcock Institute
Glebe, New South Wales, Australia, 2037
2
Fusion Clinical Research
Adelaide, South Australia, Australia, 5000