Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia

• Status: Not yet recruiting
• Trial end date: 2022-08-14
• Target enrollment: 0
• Participant gender: All

Summary

Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too early in the morning, or having unrefreshing sleep. Defined CBD is a capsule composed of highly purified (>99.9%) hemp-derived cannabidiol (CBD) and terpenes produced as a potential sleep aid for people with insomnia. This product contains no detectable Delta-9-tetrahydrocannabinol (Delta-9-THC). This trial is specifically designed to evaluate the efficacy of Defined CBD on sleep physiology in people with insomnia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Defined Research

Criteria

Inclusion Criteria:

1. Has provided a signed and dated informed consent form.

2. Presence of chronic insomnia defined as self-reported difficulty initiating (latency to persistent sleep >30 min) and/or maintaining sleep (>30 mins awake during the middle of the night, or waking >30 mins before desired waking time on three or more nights per week) for at least 3 months.

3. Insomnia Severity Index score >15.

4. Male or female aged 25-70 years.

5. Is willing to comply with all study procedures throughout the entire study, including:

• Wearing a sleep-tracking device on their wrist throughout entire clinical study.

• Ensuring that the sleep-tracking device is connected to their smartphone via Bluetooth on a daily basis so that sleep data can be collected on a daily basis.

• Ensuring that the sleep-tracking device is charged before going to bed each night, ensuring that sleep data can be collected on a daily basis.

• Is willing to receive and respond to daily text (SMS) notifications for the duration of the entire clinical study.

• During the treatment phases of the study, is willing to take the treatment for at least four nights in each week.

6. On the nights in which the participant takes the treatment, is willing to abstain from excessive alcohol intake (>two drinks/day).

7. On the nights in which the participant takes the treatment, is willing to refrain from drinking alcohol two hours before bedtime.

8. Female subjects who:

• Are postmenopausal, with amenorrhea for at least one year before the screening interview, OR

• Are surgically sterile, OR

• If of childbearing potential agree to practice effective double barrier methods of contraception (e.g., condom + diaphragm; condom or diaphragm + spermicidal gel or foam), from the time of the signing of informed consent through the last dose of study treatment, or agree to completely abstain from intercourse.

9. Self-reported bedtime between 9 pm and midnight on four-seven nights per week.

10. Owns a smartphone.

Exclusion Criteria:

1. Self-reported body mass index > 32 calculated from patient's height (m) and weight (kg); weight (kg)/square height (m²).

2. Insomnia associated with clinically diagnosed sleep apnea (AHI greater than 15 events/hour), or movement disorders such as restless legs, periodic limb movement (PLM) (greater than 30 events/hour or greater than five events/hour with associated PLM arousals).

3. Are currently participating in a formal behavioral therapy program to facilitate sleep.

4. History of epilepsy or seizures.

5. History of liver disease.

6. Serious head injury or stroke within the past year.

7. Psychiatric disorders including major depression, bipolar, anxiety, or schizophrenia.

8. History of suicide attempt or current suicide ideation.

9. Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug.

10. Patients with a history of cardiovascular disease including poorly controlled hypertension, ischemic heart disease, arrhythmia, or severe heart failure.

11. Untreated metabolic disorder such as diabetes.

12. Medical conditions that result in frequent need to get out of bed (e.g. nocturia).

13. History of drug or alcohol abuse, including past or present history of cannabis dependence.

14. Inability to refrain from greater than two standard drinks/day of alcohol consumption for study duration.

15. Current cigarette smoker.

16. Currently chronic (daily) cannabis user.

17. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including neuroleptics, morphine/opioid derivatives, antihistamines, stimulants, anti-depressants, clonidine, within one week prior to screening.

18. Use of any over-the-counter sleep medications including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St John's Wort (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root), and hemp within one week prior to screening.

19. Inability to refrain from use of any of the following contra-indicated drugs for at least one week prior to and for the duration of the study: erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, ritonavir, telaprevir, boceprevir, amlodipine, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil, diltiazem, rifampin, theophylline, tizanidine, bupropion, efavirenz, diflunisal, propofol, fenofibrate, lamotrigine, morphine, lorazepam, diazepam, clobazam, stiripentol, valproate, everolimus, sirolimus, or tacrolimus, niacin (vitamin B3 greater than 1g/ day), grapefruit juice.

20. Consumption of xanthine-containing beverages (i.e., tea, coffee, energy drinks or cola) of more than five cups or glasses per day.

21. Inability to refrain from greater than 400mg/day of caffeine consumption for study duration.

22. Participation in any other clinical trial within 30 days before the screening visit.

23. Night shift workers (during the 12 months prior to the study and during the study).

24. Individuals who nap three or more times per week over the preceding month.

25. Current delayed sleep phase syndrome where wake-up time is regularly (>5x/week) later than 9:00 a.m.

26. Individuals having to travel across more than two time zones or outside of their country of residence at any time during the study.

27. Females who are pregnant, are planning to become pregnant, or are breastfeeding.

28. History of allergies particularly to plant-based products containing terpenes, i.e. flavors and aromatic natural oils for example citrus, mango, lavender, thyme, cedarwood and pine products.

29. Known hypersensitivity to cannabinoids, including CBD.

30. Individuals may be excluded from participating in the study based on the investigator's professional judgement.