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

NCT05233761 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: DR-INS-101
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Percentage of Time Spent in the Combination of Slow Wave Sleep (SWS) and Rapid Eye Movement (REM) Sleep

  The primary endpoint is the percentage of time spent in slow wave (Deep) and REM sleep as quantified by a non-invasive wrist-worn sleep-tracking device called Whoop.

  Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period.

Secondary Outcomes (3)

• Objective Secondary Outcome Measures of Sleep Physiology

  Four weeks

• Objective Secondary Outcome Measures of Sleep Physiology

  Four weeks

• Subjective Secondary Outcome Measure of Sleep Physiology

  Participants were assessed for treatment with CBD-terpenes and placebo, each for a treatment period of four weeks. Participants took the treatment (CBD-terpenes or Placebo) for at least four nights per week over the entire four week treatment period.

Study Arms (2)

Defined CBD

EXPERIMENTAL

Defined CBD will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that contain a total of 300 mg CBD and 8 mg terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks.

Drug: Defined CBD

Placebo

PLACEBO COMPARATOR

The placebo control will be administered as two small capsules that will be taken orally with a glass of water one hour before bedtime that do not contain any CBD or terpenes. Participants will take the treatment on a minimum of four nights per week, over a total of four-weeks. The Placebo capsules will look and smell identical to the Defined CBD capsules.

Drug: Placebo

Interventions

Defined CBD DRUG

300 mg CBD and 8 mg Terpenes administered as two small capsules.

Defined CBD

Placebo DRUG

Capsules that smell and look exactly like Defined CBD but contain no CBD or terpenes.

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided a signed and dated informed consent form.
• 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.
• Insomnia Severity Index score \>15.
• Male or female aged 25-70 years.
• 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.
• On the nights in which the participant takes the treatment, is willing to abstain from excessive alcohol intake (\>two drinks/day).
• On the nights in which the participant takes the treatment, is willing to refrain from drinking alcohol two hours before bedtime.
• Female subjects who:
• Are postmenopausal, with amenorrhea for at least one year before the screening interview, OR
• Are surgically sterile, OR

You may not qualify if:

• Self-reported body mass index \> 32 calculated from patient's height (m) and weight (kg); weight (kg)/square height (m²).
• 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).
• Are currently participating in a formal behavioral therapy program to facilitate sleep.
• History of epilepsy or seizures.
• History of liver disease.
• Serious head injury or stroke within the past year.
• Psychiatric disorders including major depression, bipolar, anxiety, or schizophrenia.
• History of suicide attempt or current suicide ideation.
• 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.
• Patients with a history of cardiovascular disease including poorly controlled hypertension, ischemic heart disease, arrhythmia, or severe heart failure.
• Untreated metabolic disorder such as diabetes.
• Medical conditions that result in frequent need to get out of bed (e.g. nocturia).
• History of drug or alcohol abuse, including past or present history of cannabis dependence.
• Inability to refrain from greater than two standard drinks/day of alcohol consumption for study duration.
• Current cigarette smoker.

Sponsors & Collaborators

• Defined Research: lead

Study Sites (1)

Defined Research

San Francisco, California, 94107, United States

Location

Related Publications (1)

• Wang M, Faust M, Abbott S, Patel V, Chang E, Clark JI, Stella N, Muchowski PJ. Effects of a cannabidiol/terpene formulation on sleep in individuals with insomnia: a double-blind, placebo-controlled, randomized, crossover study. J Clin Sleep Med. 2025 Jan 1;21(1):69-80. doi: 10.5664/jcsm.11324.

  PMID: 39167421 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

First, the study was not conducted in a sleep clinic using polysomnography. Second, the wrist-worn sleep-tracking device used in the current study does not measure sleep latency and may not be sufficiently accurate to report sleep staging. Third, the unexpected high dropout rate in the study limited its statistical power, especially with respect to subjective outcome measures of sleep.

Results Point of Contact

• Title: Paul Muchowski
• Organization: Defined Research Institute

paul.muchowski@definedresearch.org

415-413-8666

Study Officials

• Paul Muchowski, Ph.D.

  Defined Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: February 18, 2022
• Primary Completion: July 2, 2022
• Study Completion: July 2, 2022
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)