Actively Recruiting
Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia
Led by Avecho Biotechnology · Updated on 2025-06-06
519
Participants Needed
5
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.
CONDITIONS
Official Title
Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older at the time of informed consent.
- Willingness to comply with all study procedures and availability for the study duration.
- Signed and dated patient information and consent form (PICF).
- Meet DSM-5 criteria for insomnia disorder with dissatisfaction in nighttime sleep (difficulty falling asleep, staying asleep, or early awakening), occurring 3 or more times per week for at least 3 months, with daytime impairment.
- History of subjective Sleep Onset Latency (sSOL) 230 minutes on at least 3 nights per week in the previous 4 weeks and/or Wake After Sleep Onset (sWASO) 230 minutes on at least 3 nights per week in the previous 4 weeks.
- Regular time in bed between 7-10 hours, either sleeping or trying to sleep.
- Insomnia Severity Index (ISI) score 215.
- Confirmation of current insomnia symptoms via Sleep Diary over at least 5 of 7 consecutive mornings, showing sSOL 230 minutes on at least 3 nights and/or sWASO 230 minutes on at least 3 nights.
- Typical bedtime between 21:00 and 01:00 and wake time between 05:00 and 10:00.
- Access to and ability to use a smartphone.
- Females of childbearing potential must use effective contraception 30 days prior to Day 1, during the study, and for 28 days after last dose, and agree to refrain from egg donation during this period.
- Male subjects not surgically sterile must use effective barrier contraception from Day 1 and for 28 days after last dose, and agree to refrain from sperm donation during this period.
You will not qualify if you...
- Insomnia caused by other sleep disorders such as narcolepsy, breathing-related disorders, circadian rhythm disorders, parasomnias, restless leg syndrome, or high risk scores on sleep disorder screening tools.
- Symptoms suggesting narcolepsy requiring diagnostic evaluation.
- History of sleep-related violent or complex behaviors.
- Beck Depression Inventory (BDI II) score >19 at screening.
- Beck Anxiety Inventory score >15 at screening.
- Habitual napping more than three times per week.
- Current or recent cannabis use within 30 days before consent and during the study.
- Use of drugs affecting sleep within 30 days before screening and during the study, including sedatives, opioids, stimulants, antipsychotics, melatonin, valerian, and certain antidepressants.
- Care responsibilities for an infant under 1 year.
- Pregnancy or lactation.
- Excessive caffeine use (>300 mg/day) contributing to insomnia and unwillingness to avoid caffeine after 4:00 pm during the study.
- History of severe bronchial asthma, obstructive sleep apnea, hypoxia, or other airway diseases increasing respiratory risk.
- History of neurological conditions such as seizures, severe head injury, or increased intracranial pressure.
- Reduced kidney function with creatinine clearance <85 mL/min.
- Elevated liver enzymes (ALT or AST >1.5 times upper limit of normal).
- Significant cardiovascular, pulmonary, neurological, renal, hepatic, gastrointestinal, hematological, endocrine, or psychiatric disorders.
- Use of over-the-counter hemp or cannabidiol products within 30 days before screening and during the study.
- Known allergy or intolerance to cannabis or cannabidiol products.
- Use of moderate or strong CYP3A4 or CYP2C19 inhibitors within 2 weeks before randomization.
- Excessive alcohol use or unwillingness to abstain from alcohol within 3 hours before bedtime.
- Recreational drug use or positive drug tests at screening and study visits.
- Participation in another clinical trial or use of investigational drugs within 30 days before screening.
- Use of anticoagulants like warfarin or drugs metabolized by CYP450 within 30 days before screening.
- Use of insomnia treatments such as cognitive-behavioral therapy or CNS-active drugs within 30 days before screening.
- Frequent nocturia causing more than two bathroom visits per night.
- Any medical or psychiatric condition that may affect safety or study assessments.
- Scheduled major surgery during the study.
- Shift work, jet lag, or travel across three time zones within the past month and during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Pioneer Clinical Research
North Sydney, New South Wales, Australia, 2060
Not Yet Recruiting
2
Key Health, CBD South
Sydney, New South Wales, Australia, 2000
Not Yet Recruiting
3
Griffith University
Southport, Queensland, Australia, 4222
Not Yet Recruiting
4
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
5
Captain Stirling Medical Centre
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
P
Paul Gavin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here