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InsomniaPhase 3NCT05840822

Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia

A Phase 3 study testing Cannabidiol (CBD) Capsule 75mg in people with Insomnia, run by Avecho Biotechnology at 5 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insomnia
What is being tested?
Cannabidiol (CBD) Capsule 75mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
519 participants
Where
5 sitesAustralia
Study dates
16 May 2024to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged 18 years or older at the time of informed consent.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Provide a signed and dated patient information and consent form (PICF) for the study.
  • 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.
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  • Duration of complaint ≥3 months.
  • Associated with a complaint of daytime impairment.
  • 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.
  • Subject reports a regular time spent in bed, either sleeping or trying to sleep is between 7-10 hours.
  • Subjects must have clinical insomnia symptoms as classified by an insomnia severity index (ISI) Score of ≥15.
  • 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.
  • 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.
  • Subject has access to and is able to use a smart phone.
  • 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).
  • 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).

Who cannot join

  • Significant insomnia caused during another sleep-wake disorder, including narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia, restless leg syndrome, or an exclusionary score on the Sleep Disorders Screening Battery, or Epworth Sleepiness Scale score as follows:
  • 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).
  • 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.
  • 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.
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  • Beck Depression Inventory - (BDI II) score >19 at Screening.
  • Beck Anxiety Inventory >15 at Screening.
  • Habitually napped more than three times per week.
  • Current or recent cannabis use, within 30 days of consent, and throughout the study.
  • 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).
  • Have care responsibilities for an infant <1 year of age.
  • Females who are pregnant or lactating.
  • 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.
  • 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.
  • History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure.
  • A calculated creatinine clearance of < 85 mL/minute at Screening according to the equation using Cockcroft and Gault.
  • Liver function tests for alanine transaminase or aspartate aminotransferase > 1.5 times the upper limit of normal at Screening.
  • 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.
  • 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.
  • Known intolerance, allergy or hypersensitivity reactions to cannabis or cannabinoid products (e.g. hemp), and excipients of the IP.
  • 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.
  • 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.
  • Recreational drug use, including positive results for the urine drugs of abuse test during at Screening, Compliance Check and Run-in/Randomization (Baseline) visits.
  • Use of any investigational drug or involvement in another clinical trial within 30 days of Screening.
  • Use of anti-coagulant drugs such as warfarin or those known to be metabolized by CYP450 enzymes, within 30 days of Screening.
  • Use of treatments for insomnia (e.g. cognitive-behavioral therapy and Central Nervous System-active drugs), within 30 days of Screening.
  • Self-reported or physician diagnosed comorbid nocturia resulting in frequent (>2) need to get out of bed to use the bathroom during the night.
  • 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.
  • Scheduled for major surgery during the study.
  • Shift work, jet lag or trans-meridian travel (three time zones) in the past month, at Screening and while on study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Monash Health

    Clayton, Victoria, 3168

  • Captain Stirling Medical Centre

    Nedlands, Western Australia, 6009

  • Pioneer Clinical Research

    North Sydney, New South Wales, 2060

  • Griffith University

    Southport, Queensland, 4222

  • Key Health, CBD South

    Sydney, New South Wales, 2000

Other trials in Australia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity

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
Insomnia
Being tested
Cannabidiol (CBD) Capsule 75mg, Placebo
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabidiol (CBD) Capsule 75mgDrug

    Cannabidiol (CBD) capsule containing 75mg CBD

  • PlaceboDrug

    Placebo capsule without cannabidiol

Study groups in NCT05840822
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNightly dose of two placebo capsules
Receives: Drug: Placebo
75mg CBDExperimentalNightly dose of one 75mg CBD capsule and one placebo capsule
Receives: Drug: Cannabidiol (CBD) Capsule 75mg; Drug: Placebo
150mg CBDExperimentalNightly dose of two 75mg CBD capsules
Receives: Drug: Cannabidiol (CBD) Capsule 75mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from study baseline of insomnia severity index (ISI) score at 8 weeks

    The insomnia severity index (ISI) is a seven-item self-report questionnaire used to assess the severity of the insomnia disorder.

    Total score ranges from 0-28. 0 - 7 No clinically significant insomnia. 8 - 14 Subthreshold insomnia. 15 - 21 Clinical insomnia (moderate severity) 22 - 28 Clinical insomnia (severe)

    Measured: 8 weeks

  2. Mean change from study baseline in subject sleep efficiency (sSE) at 8 weeks

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start16 May 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
519 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05840822
Sponsor's protocol ID
AVE047-22
Status last verified
Jun 2026
First submitted
23 Apr 2023
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cannabidiol (CBD) Capsule 75mg in people with Insomnia, run by Avecho Biotechnology at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from study baseline of insomnia severity index (ISI) score at 8 weeks (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05840822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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