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OpenTrials
Completed

NCT Number: NCT05518019

An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus

A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.

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Key information

Conditions

Anxiety Anxiety Disorders Consciousness Disorders Fear Low Mood Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Stress

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day).
  • Must be in general good health (e.g., no long term health issues that would impact your participation.
  • Moderate self-reported issues with stress, mood, focus, and sleep.

Exclusion criteria

  • Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days.
  • Currently receiving other psychotherapeutic treatment for anxiety or depression.
  • Diagnosed anxiety or depression
  • BMI over 40
  • Known allergic reactions that would require the use of an epi-pen
  • Females who are pregnant or breastfeeding.

Treatment and study plan

The Daily Supplement

Dietary Supplement

Each serving of the dietary supplement (defined as 1 softgel) contains the following formulation:

Organic Broad Spectrum Hemp Extract 35mg Bio-Terpene Complex 52mg Palm Monoglycerides Organic Hemp Seed Oil, Clove Bud Oil, Black Pepper Berry Essential Oil Curcumin (Turmeric Root) Essential Oil

Inactive ingredients: Organic Flaxseed Oil, Gel Shell (Modified Tapioca Starch, Glycerin, Purified Water, Maltitol

Primary outcomes

  1. Change in stress and anxiety as measured by questionnaires.

    Time frame: 2 months

    Feeling states that will be measured include stress, calmness, balance, relaxation, and focus

    Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")

  2. Change in mood as measured by questionnaire

    Time frame: 2 months

    Feeling states that will be measured include stress, calmness, balance, relaxation, and focus

    Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")

Secondary outcomes

  1. Change in sleep quality and quantity as measured by digital wearable devices and by self-report

    Time frame: 2 months

    Sleep will be measured two ways. Questionnaires will be used to assess sleep quality and quantity.

    Participants will also use wearable devices to track their sleep over the course of the study.

Other outcomes

  1. Change in overall well-being as measured by self-report and questionnaires.

    Time frame: 2 months

    Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")

Sponsors and collaborators

Lead sponsor

Prima CBD

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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