The CANabidiol Use for RElief of Short Term Insomnia

NCT05253417 | Completed Phase 2

• 1 other identifier: BOD202101
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Disturbance; Insomnia; Insomnia Type; Sleep Disorder; Insomnia, Transient; Insomnia Due to Anxiety and Fear; Insomnia Due to Other Mental Disorder

Keywords

Insomnia; sleep; fatigue; cannabidiol; CBD; mental health; anxiety

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of the administration of a 50mg and 100mg per day oral CBD product versus placebo over 8 weeks on insomnia severity index scores

  Insomnia Severity Index (ISI): A 7-item tool measuring the nature, severity, and impact of insomnia over the past 2 weeks. Each item uses a 5-point Likert scale to capture a rating (0 = no problem; 4 = very severe problem) which add up to: no insomnia (0 - 7); sub-threshold insomnia (8 - 14); moderate insomnia (15 - 21); and severe insomnia (22 - 28).

  Baseline (week 0), week 4, week 8

Secondary Outcomes (3)

• To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on wake after sleep onset (WASO) as assessed by actigraphy.

  Baseline (week 0), week 8

• To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Anxiety as assessed by the DASS-21 questionnaire.

  Baseline (week 0), Week 4, week 8

• To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Stress as assessed by the DASS-21 questionnaire.

  Baseline (week 0), Week 4, week 8

Other Outcomes (9)

• To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Sleep onset latency (SOL) measured by actigraphy.

  Baseline (week 0), week 8

• To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on subjective sleep as assessed by sleep diaries

  Baseline (week 0), week 4, week 8

• To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on self-perception of improvement in sleep as assessed by a self-report questionnaire.

  Baseline (week 0), week 4, week 8

Study Arms (3)

50 mg CBD

EXPERIMENTAL

50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)

Drug: 50 mg Cannabidiol (CBD); Drug: Placebo; Drug: 100 mg Cannabidiol (CBD)

100 mg CBD

EXPERIMENTAL

100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken.

Drug: 50 mg Cannabidiol (CBD); Drug: 100 mg Cannabidiol (CBD)

Placebo

PLACEBO COMPARATOR

Placebo capsules contain no CBD. Four capsules to be taken as a single oral dose.

Drug: Placebo

Interventions

50 mg Cannabidiol (CBD) DRUG

For the study arm, '50 mg CBD' participants take two (2) CBD capsules and two (2) placebo capsules.

Also known as: BodECS BioAbsorb(TM) capsule

100 mg CBD; 50 mg CBD

Placebo DRUG

Participants take four (4) placebo capsules.

50 mg CBD; Placebo

100 mg Cannabidiol (CBD) DRUG

For the study arm, '100 mg CBD' participants take four (4) CBD capsules.

Also known as: BodECS BioAbsorb(TM) capsule

100 mg CBD; 50 mg CBD

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bod Australia: lead
• Woolcock Institute of Medical Research: collaborator

Study Sites (2)

Woolcock Institute

Glebe, New South Wales, 2037, Australia

Location

Fusion Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Fatigue; Psychological Well-Being; Anxiety Disorders

Interventions

Cannabidiol; Capsules

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ron Grunstein

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind: Study staff (including the study investigators, the clinical trials coordinator and the study medical officer) and the participants will be blinded. Blinding will be maintained by the use of identical containers and labels except for the patient identification code and unique batch number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, placebo-controlled, double-blind, parallel trial

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 23, 2022
• Study Start: May 1, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)