Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia
NCT ID: NCT05840822
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
519 participants
INTERVENTIONAL
2024-05-16
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The CANabidiol Use for RElief of Short Term Insomnia
NCT05253417
Cannabinol Use in Patients With Insomnia Disorder
NCT05344170
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of CBN With and Without CBD on Sleep Quality
NCT05839964
Cannabinoids as a Treatment for Insomnia in Major Depression
NCT05041647
Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
NCT05233761
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Nightly dose of two placebo capsules
Placebo
Placebo capsule without cannabidiol
75mg CBD
Nightly dose of one 75mg CBD capsule and one placebo capsule
Cannabidiol (CBD) Capsule 75mg
Cannabidiol (CBD) capsule containing 75mg CBD
Placebo
Placebo capsule without cannabidiol
150mg CBD
Nightly dose of two 75mg CBD capsules
Cannabidiol (CBD) Capsule 75mg
Cannabidiol (CBD) capsule containing 75mg CBD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cannabidiol (CBD) Capsule 75mg
Cannabidiol (CBD) capsule containing 75mg CBD
Placebo
Placebo capsule without cannabidiol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Provide a signed and dated patient information and consent form (PICF) for the study.
4. Met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder, as follows:
* Complained of dissatisfaction with night-time sleep in the form of difficulty getting to sleep, difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep.
* Frequency of the complaint ≥3 times per week.
* Duration of complaint ≥3 months.
* Associated with a complaint of daytime impairment.
5. History of subjective Sleep Onset Latency (sSOL) ≥30 minutes on at least 3 nights per week in the previous 4 weeks AND/OR subjective Wake After Sleep Onset (sWASO) ≥30 minutes on at least 3 nights per week in the previous 4 weeks.
6. Subject reports a regular time spent in bed, either sleeping or trying to sleep is between 7-10 hours.
7. Subjects must have clinical insomnia symptoms as classified by an insomnia severity index (ISI) Score of ≥15.
8. Confirmation of current insomnia symptoms as determined from the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥30 minutes on at least 3 of the 7 nights.
9. Subject reports a typical bedtime, (defined as the time the subject attempts to sleep), between 21:00 and 01:00, and waketime, (defined as the time the subject got out of bed for the day), between 05:00 and 10:00.
10. Subject has access to and is able to use a smart phone.
11. Female subjects of childbearing potential must be abstinent or agree to use a highly effective method of contraception for 30 days prior to Day 1, during the study, and for at least 28 days following the last dose of Investigational Product (IP). Agrees to refrain from donating eggs (ova, oocytes) (from Day 1 until 28 days following the last dose of IP).
12. Male subjects that are not surgically sterile (i.e., vasectomy) must be abstinent or agree to use effective barrier contraception (i.e., condom) from Day 1 and for at least 28 days following the last dose of IP and agrees to refrain from sperm donation (from Day 1 until 28 days following the last dose of IP).
Exclusion Criteria
* STOP-Bang score ≥5.
* International Restless Legs Scale score ≥16.
* Epworth Sleepiness Scale score \>15 (scores of 11-15 required excessive daytime sleepiness to be recorded in subject's medical history).
2. Reports symptoms potentially related to narcolepsy that in the clinical opinion of the Investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy.
3. Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior, e.g., making phone calls, or preparing and eating food while asleep.
4. Beck Depression Inventory - (BDI II) score \>19 at Screening.
5. Beck Anxiety Inventory \>15 at Screening.
6. Habitually napped more than three times per week.
7. Current or recent cannabis use, within 30 days of consent, and throughout the study.
8. Use of any drug known to affect sleep, within 30 days of Screening and throughout the study, including:
* Sedatives (e.g. benzodiazepines, zopiclone, eszopiclone, zaleplon, zolpidem, agomelatine, suvorexant, dual orexin receptor antagonists, sodium oxybate mirtazipine (sedating SSRI) and all tricyclic antidepressants,, , sedating H antihistamines (cyproheptadine, dexchlorpheniramine, promethazine, trimeprazine, doxylamine, diphenhydramine, cyclizine),, antipsychotics, melatonin, valerian).
* Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).
* Stimulants (e.g. modafinil, methylphenidate, dexamphetamine, phentermine).
9. Have care responsibilities for an infant \<1 year of age.
10. Females who are pregnant or lactating.
11. Have excessive caffeine use (\>300 mg or \~3 cups of caffeinated beverages a day) that, in the opinion of the Investigator, contributes to the subject's insomnia, and is unwilling to forgo caffeine-containing beverages for the duration of their participation in the study. Any caffeine consumed needs to be prior to 4:00 pm.
12. PI determined excessive history of acute or severe bronchial asthma (excluding childhood or exercise induced asthma), diagnosed obstructive sleep apnea, hypoxia, hypoxemia, hypercarbia, or other obstructive airway disease or any condition that may increase the risk for respiratory depression.
13. History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure.
14. A calculated creatinine clearance of \< 85 mL/minute at Screening according to the equation using Cockcroft and Gault.
15. Liver function tests for alanine transaminase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening.
16. History of clinically significant (in the opinion of the Investigator) other cardiovascular, pulmonary, neurologic or renal disorders or hepatic, gastrointestinal, oral (difficulty swallowing / taking oral medication), hematological, endocrine, or psychiatric impairment/disorders.
17. Use of any over the counter product, or other medicine derived from hemp or containing cannabidiol, within 30 days of Screening and for duration of study.
18. Known intolerance, allergy or hypersensitivity reactions to cannabis or cannabinoid products (e.g. hemp), and excipients of the IP.
19. Currently taking or have taken drugs that are moderate or strong inhibitors of CYP3A4 or CYP2C19 within 2 weeks or 5 half-lives, whichever is longer, prior to randomisation.
20. Excessive use of alcohol (i.e. drink more than 2 standard units of alcohol per day or \>8 standard units per week), including positive results for the alcohol breath test at Screening, Compliance Check, and Run-in/Randomization (Baseline) visits or is unwilling to abstain from alcohol consumption within 3 hours before bedtime for the duration of their participation in the study.
21. Recreational drug use, including positive results for the urine drugs of abuse test during at Screening, Compliance Check and Run-in/Randomization (Baseline) visits.
22. Use of any investigational drug or involvement in another clinical trial within 30 days of Screening.
23. Use of anti-coagulant drugs such as warfarin or those known to be metabolized by CYP450 enzymes, within 30 days of Screening.
24. Use of treatments for insomnia (e.g. cognitive-behavioral therapy and Central Nervous System-active drugs), within 30 days of Screening.
25. Self-reported or physician diagnosed comorbid nocturia resulting in frequent (\>2) need to get out of bed to use the bathroom during the night.
26. Any history of a medical or psychiatric condition that, in the opinion of the Investigator, may affect the subject's safety or interfere with the study assessments.
27. Scheduled for major surgery during the study.
28. Shift work, jet lag or trans-meridian travel (three time zones) in the past month, at Screening and while on study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avecho Biotechnology
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Darren Mansfield
Role: PRINCIPAL_INVESTIGATOR
Monash Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pioneer Clinical Research
North Sydney, New South Wales, Australia
Key Health, CBD South
Sydney, New South Wales, Australia
Griffith University
Southport, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Captain Stirling Medical Centre
Nedlands, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AVE047-22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.