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

NCT05840822 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: AVE047-22
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 5

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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)

  8 weeks

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

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Nightly dose of two placebo capsules

Drug: Placebo

75mg CBD

EXPERIMENTAL

Nightly dose of one 75mg CBD capsule and one placebo capsule

Drug: Cannabidiol (CBD) Capsule 75mg; Drug: Placebo

150mg CBD

EXPERIMENTAL

Nightly dose of two 75mg CBD capsules

Drug: Cannabidiol (CBD) Capsule 75mg

Interventions

Cannabidiol (CBD) Capsule 75mg DRUG

Cannabidiol (CBD) capsule containing 75mg CBD

150mg CBD; 75mg CBD

Placebo DRUG

Placebo capsule without cannabidiol

75mg CBD; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Avecho Biotechnology: lead

Study Sites (5)

Pioneer Clinical Research

North Sydney, New South Wales, 2060, Australia

NOT YET RECRUITING

Key Health, CBD South

Sydney, New South Wales, 2000, Australia

NOT YET RECRUITING

Griffith University

Southport, Queensland, 4222, Australia

NOT YET RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Captain Stirling Medical Centre

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cannabidiol; Capsules

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Darren Mansfield

  Monash Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Gavin

CONTACT

+61390025000; pgavin@avecho.com.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 3, 2023
• Study Start: May 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)