Clinical trial NCT05253417: The CANabidiol Use for RElief of Short Term Insomnia
Official title: The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Bod Australia
Sponsor class: INDUSTRY
Collaborators: name: Woolcock Institute of Medical Research
First posted: 2022-02-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, placebo-controlled, double-blind, parallel trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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
timeFrame: Baseline (week 0), week 4, week 8
Secondary outcomes:
measure: 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.
timeFrame: Baseline (week 0), week 8
measure: 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.
timeFrame: Baseline (week 0), Week 4, week 8
measure: 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.
timeFrame: Baseline (week 0), Week 4, week 8
Other outcomes:
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Sleep onset latency (SOL) measured by actigraphy.
timeFrame: Baseline (week 0), week 8
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on subjective sleep as assessed by sleep diaries
timeFrame: Baseline (week 0), week 4, week 8
measure: 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.
timeFrame: Baseline (week 0), week 4, week 8
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Subjective sleep-related quality of life as assessed by the Functional Outcomes Sleep Questionnaire (FOSQ-10).
timeFrame: Baseline (week 0), week 4, week 8
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Fatigue assessed by the Flinders Fatigue Scale;
timeFrame: Baseline (week 0), week 4, week 8
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Health-related quality of life (HRQoL) assessed using the EQ-5D-5L.
timeFrame: Baseline (week 0), week 4, week 8
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD on the number of participants with treatment-emergent adverse events
timeFrame: Week 4, Week 8, Week 12
measure: To determine relationship between efficacy endpoint and systemic concentrations of CBD and its carboxy and hydroxy metabolites
timeFrame: Baseline (week 0), week 8
measure: To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Depression as assessed by the DASS-21 questionnaire.
timeFrame: Baseline (week 0), Week 4, week 8
Locations:
city: Glebe
country: Australia
facility: Woolcock Institute
state: New South Wales
city: Adelaide
country: Australia
facility: Fusion Clinical Research
state: South Australia
Study officials:
affiliation: Woolcock Institute of Medical Research
name: Ron Grunstein
role: PRINCIPAL_INVESTIGATOR
References: