Anxiety Clinical Trial
Official title:
An Exploratory Investigation of a CBD Supplement's Impact on Sleep, Stress, and Focus
NCT number | NCT05518019 |
Other study ID # | 20236 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 14, 2022 |
Est. completion date | June 29, 2022 |
Verified date | August 2022 |
Source | Prima CBD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 29, 2022 |
Est. primary completion date | June 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Citruslabs | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Prima CBD | Citruslabs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in overall well-being as measured by self-report and questionnaires. | 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 months | |
Primary | Change in stress and anxiety as measured by questionnaires. | 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 months | |
Primary | Change in mood as measured by questionnaire | 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 months | |
Secondary | Change in sleep quality and quantity as measured by digital wearable devices and by self-report | 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. |
2 months |
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