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Can a CBD pill help you sleep better? new study investigates

NCT ID NCT05233761

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a capsule containing cannabidiol (CBD) and terpenes to see if it improves sleep quality in people with chronic insomnia. 125 adults with insomnia took either the CBD capsule or a placebo for a period, and their sleep was tracked with a wrist device. The goal was to measure time spent in deep and REM sleep stages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabidiol (CBD) and terpenes
What this could lead to
If it works, this could point toward a non-prescription sleep aid for people with insomnia.
What could go wrong
This is a Phase 2 trial, so results are still early. The effect on sleep may be small or no better than placebo, and individual responses to CBD vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

125 people

The number who actually took part.

Started

Feb 2022

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Defined Research

    San Francisco, California, 94107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.