Sleep DisturbancePhase 2CANRESTNCT05253417
The CANabidiol Use for RElief of Short Term Insomnia
A Phase 2 study testing 50 mg Cannabidiol (CBD) and 100 mg Cannabidiol (CBD) in people with Sleep Disturbance and Insomnia, run by Bod Australia at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Disturbance, Insomnia, Insomnia Type; Sleep Disorder
- What is being tested?
- 50 mg Cannabidiol (CBD) and 100 mg Cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 May 2022to 7 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Medical conditions that result in frequent sleep disturbance (e.g. nocturia).
- History of attempted suicide in the past 12 months.
- Clinically significant hepatic abnormalities determined by the screening blood test.
- Shift work, jet lag or trans-meridian travel (two time zones) in the past month.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Fusion Clinical Research
Adelaide, South Australia, 5000
Woolcock Institute
Glebe, New South Wales, 2037
About this study
Official title: The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study
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.
Read the 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
- Being tested
- 50 mg Cannabidiol (CBD), Placebo, 100 mg Cannabidiol (CBD)
- Keywords
- Insomnia, sleep, fatigue, cannabidiol, CBD, mental health, anxiety
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Fatigue, Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg Cannabidiol (CBD)Drug
Also called BodECS BioAbsorb(TM) capsule
For the study arm, '50 mg CBD' participants take two (2) CBD capsules and two (2) placebo capsules.
PlaceboDrug
Participants take four (4) placebo capsules.
100 mg Cannabidiol (CBD)Drug
Also called BodECS BioAbsorb(TM) capsule
For the study arm, '100 mg CBD' participants take four (4) CBD capsules.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
WASO is a parameter that examines the total amount of minutes awake after the first sleep epoch is achieved. Therefore, as the WASO increases, sleep efficiency decreases.
Measured: 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.
Depression Anxiety Stress Scale-21 (DASS-21): A 21-item tool with subscales measuring the negative emotional states of depression, anxiety, and stress separately. Depression ranges from normal (0-9) to extremely severe (28+); anxiety ranges from normal (0-7) to extremely severe (20+); and stress ranges from normal (0-14) to extremely severe (34+).
Measured: 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.
Depression Anxiety Stress Scale-21 (DASS-21): A 21-item tool with subscales measuring the negative emotional states of depression, anxiety, and stress separately. Depression ranges from normal (0-9) to extremely severe (28+); anxiety ranges from normal (0-7) to extremely severe (20+); and stress ranges from normal (0-14) to extremely severe (34+).
Measured: Baseline (week 0), Week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 May 2022
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, placebo-controlled, double-blind, parallel trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bod Australia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Woolcock Institute of Medical Research
- Responsible party
- Sponsor
- Investigators
- Ron Grunstein, Principal investigator, Woolcock Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253417
- Sponsor's protocol ID
- BOD202101
- Acronym
- CANREST
- Status last verified
- Aug 2023
- First submitted
- 20 Dec 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05253417
- Acronym / sponsor ID
- CANREST / BOD202101
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Bod AustraliaIndustry (pharma, biotech, devices)
- Collaborators
- Woolcock Institute of Medical Research
- Study start
- 1 May 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomised, placebo-controlled, double-blind, parallel trial
| Arm | Type | Receives |
|---|---|---|
| 50 mg CBD | Experimental | Drug: 50 mg Cannabidiol (CBD), Drug: Placebo, Drug: 100 mg Cannabidiol (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) |
| 100 mg CBD | Experimental | Drug: 50 mg Cannabidiol (CBD), Drug: 100 mg Cannabidiol (CBD)100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules contain no CBD. Four capsules to be taken as a single oral dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg Cannabidiol (CBD)Also: BodECS BioAbsorb(TM) capsuleFor the study arm, '50 mg CBD' participants take two (2) CBD capsules and two (2) placebo capsules. | Drug | 100 mg CBD, 50 mg CBD |
| PlaceboParticipants take four (4) placebo capsules. | Drug | 50 mg CBD, Placebo |
| 100 mg Cannabidiol (CBD)Also: BodECS BioAbsorb(TM) capsuleFor the study arm, '100 mg CBD' participants take four (4) CBD capsules. | Drug | 100 mg CBD, 50 mg CBD |
Primary outcome
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
Time frame: Baseline (week 0), week 4, week 8
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).
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (week 0), Week 4, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Sleep Disturbance
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Grunstein principal investigator
Woolcock Institute of Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 mg Cannabidiol (CBD) and 100 mg Cannabidiol (CBD) in people with Sleep Disturbance and Insomnia, run by Bod Australia at 2 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: Baseline (week 0), week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2023.