The CANabidiol Use for RElief of Short Term Insomnia

NCT ID: NCT05253417

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-07-07

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.

Detailed Description

This is a double-blind, randomised, parallel-group, placebo-controlled study of 8 weeks of oral CBD at 50 or 100 mg per day versus placebo in 198 participants with insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8-21. Participants will be recruited voluntarily and are able to withdraw at any time. The study will be conducted online with telehealth consults where required.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

50 mg CBD

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)

Group Type: EXPERIMENTAL

50 mg Cannabidiol (CBD)

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Participants take four (4) placebo capsules.

100 mg Cannabidiol (CBD)

Intervention Type: DRUG

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

100 mg CBD

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

Group Type: EXPERIMENTAL

50 mg Cannabidiol (CBD)

Intervention Type: DRUG

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

100 mg Cannabidiol (CBD)

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants take four (4) placebo capsules.

Interventions

50 mg Cannabidiol (CBD)

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

Intervention Type: DRUG

Placebo

Participants take four (4) placebo capsules.

Intervention Type: DRUG

100 mg Cannabidiol (CBD)

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

Intervention Type: DRUG

Other Intervention Names

BodECS BioAbsorb(TM) capsule; BodECS BioAbsorb(TM) capsule

Eligibility Criteria

Inclusion Criteria

1. Male and females aged 18-65 years old, inclusive.

2. Females must be non-pregnant, non-lactating.

3. Proficient in English and have internet access and a mobile phone.

4. 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.

5. Stated willingness to comply with all study procedures and availability for the duration of the study.

6. Provision of signed and dated informed consent form.

7. 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.

Exclusion Criteria

1. Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.

2. The use of any drug known to affect sleep during the study one week prior the randomization, including:

1. Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate, sedating antidepressants, sedating antihistamines, antipsychotics, melatonin, valerian).

2. Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).

3. Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).

3. 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.

4. 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).

5. 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.

6. Cannabis dependence or any other drug or alcohol dependence within the past two years.

7. 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.

8. Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.

9. Use of any investigational drug or involvement in another clinical trial within 30 days of screening day.

10. Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.

11. Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT) and CNS-active drugs).

12. Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported sleep disorders.

13. Medical conditions that result in frequent sleep disturbance (e.g. nocturia).

14. History of attempted suicide in the past 12 months.

15. Clinically significant hepatic abnormalities determined by the screening blood test.

16. Shift work, jet lag or trans-meridian travel (two time zones) in the past month.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woolcock Institute of Medical Research

OTHER

Sponsor Role: collaborator

Bod Australia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Grunstein

Role: PRINCIPAL_INVESTIGATOR

Woolcock Institute of Medical Research

Locations

Woolcock Institute

Glebe, New South Wales, Australia

Fusion Clinical Research

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

BOD202101

Identifier Type: -

Identifier Source: org_study_id