AnxietyNCT05108220
Evaluation of Effects of CBD Products on Anxiety Among U.S. Women
An observational study of Anxiety and Generalized Anxiety Disorder, run by Radicle Science at 1 site in United States.
Trial summary
The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Read more about this study
- Who is it for?
- Ages 24 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Generalized Anxiety Disorder
- What is being tested?
- Cannabidiol (CBD)- containing consumer products
- Type of treatment
- Pill or oral medicine
- How many people
- 1,350 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 1350 women from across the United States
Who may be able to join
- Self-identified female
- Ages of 24 to 44 years
- Reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido).
Who cannot join
- -Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Cohort Study to Evaluate the Effects of Cannabidiol (CBD)-Containing Test Products on Anxiety Among Women in the U.S.
The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Participants were randomized to one of 9 groups: 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery, concentration of Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.
Read the detailed description
Between October 1-7, 2020, women from across the US were recruited by Rae Wellness to participate in a 60-day in-home use test (IHUT) of various Cannabidiol (CBD) products. The inclusion criteria were: women; between the ages of 24-44; reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido). Individuals were excluded if they were pregnant or breastfeeding. 1,350 women were randomly selected to participate in the study. The participants were randomized to one of 9 groups in the IHUT (150 in each group): 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery (oil or capsule), concentration of Tetrahydrocannabinol (THC; less than 0.3% THC or 0% THC), and dosage of CBD (15, 20, 25 and 30 mg). Participants were asked to use the product once daily every day for 60 consecutive days, and to complete a health questionnaire online on 3 occasions: before initiating the product (baseline), 30 days after initiating the product, and 60 days after initiating the product. Those in the control group were also asked to complete the health questionnaire at each time point but did not receive nor consume any CBD product. The health questionnaire assessed anxiety, physical health, digestive health, sleep patterns, general wellness and sexual satisfaction using questions drawn from validated health indices.
- Conditions
- Anxiety, Generalized Anxiety Disorder
- Being tested
- Cannabidiol (CBD)- containing consumer products
- Keywords
- Cannabidiol, Tetrahydrocannabinol, Anxiety, Women
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)- containing consumer productsDietary supplement
Oils or capsules containing CBD which could be purchased commercially within the U.S.
| Study group | Role | What they receive |
|---|---|---|
| R-101 | CBD oil, 30 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-102 | CBD oil, 20 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-103 | CBD oil, 30 mg CBD per serving, <0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-104 | CBD oil, 20 mg CBD per serving, <0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-105 | CBD capsule, 15 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-106 | CBD capsule, 25 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-107 | CBD capsule, 15 mg CBD per serving, <0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| R-108 | CBD capsule, 25 mg CBD per serving, <0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method Receives: Dietary Supplement: Cannabidiol (CBD)- containing consumer products | |
| Control | Waitlist control; no product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety score, according to the Generalized Anxiety Disorder (GAD)-7 scale. Scores range from 0 to 21, with higher scores representing more severe anxiety.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start15 Oct 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108220
- Sponsor's protocol ID
- Pro00054510
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study to Evaluate the Effects of Cannabidiol (CBD)-Containing Test Products on Anxiety Among Women in the U.S.
- ClinicalTrials.gov ID
- NCT05108220
- Acronym / sponsor ID
- Pro00054510
- Conditions
- Anxiety, Generalized Anxiety Disorder
- Keywords
- Cannabidiol, Tetrahydrocannabinol, Anxiety, Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a retrospective cohort analysis of a consumer trial conducted by Rae Wellness. The trial took place between October 15, 2020 and December 30, 2020 and involved 1350 U.S. women who used in-home use tests (IHUT) of various Cannabidiol (CBD) products. Participants were randomized to one of 9 groups: 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery, concentration of Tetrahydrocannabinol (THC), and dosage of CBD. Participants were asked to use the product once daily for 60 day and to complete health questionnaires at baseline, 30 days and 60 days.
Detailed description
Between October 1-7, 2020, women from across the US were recruited by Rae Wellness to participate in a 60-day in-home use test (IHUT) of various Cannabidiol (CBD) products. The inclusion criteria were: women; between the ages of 24-44; reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido). Individuals were excluded if they were pregnant or breastfeeding. 1,350 women were randomly selected to participate in the study. The participants were randomized to one of 9 groups in the IHUT (150 in each group): 8 groups received one of 8 different CBD products in the mail, and one group served as the control and did not consume any CBD product. The CBD products varied by method of delivery (oil or capsule), concentration of Tetrahydrocannabinol (THC; less than 0.3% THC or 0% THC), and dosage of CBD (15, 20, 25 and 30 mg). Participants were asked to use the product once daily every day for 60 consecutive days, and to complete a health questionnaire online on 3 occasions: before initiating the product (baseline), 30 days after initiating the product, and 60 days after initiating the product. Those in the control group were also asked to complete the health questionnaire at each time point but did not receive nor consume any CBD product. The health questionnaire assessed anxiety, physical health, digestive health, sleep patterns, general wellness and sexual satisfaction using questions drawn from validated health indices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| R-101 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD oil, 30 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method |
| R-102 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD oil, 20 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method |
| R-103 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD oil, 30 mg CBD per serving, <0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method |
| R-104 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD oil, 20 mg CBD per serving, <0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method |
| R-105 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD capsule, 15 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method |
| R-106 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD capsule, 25 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method |
| R-107 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD capsule, 15 mg CBD per serving, <0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method |
| R-108 | – | Dietary Supplement: Cannabidiol (CBD)- containing consumer productsCBD capsule, 25 mg CBD per serving, <0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method |
| Control | – | –Waitlist control; no product |
Who may qualify
- Ages
- 24 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1350 women from across the United States
Key inclusion criteria (3 listed)
- Self-identified female
- Ages of 24 to 44 years
- Reported symptoms associated with at least 4 out of 6 health issues (stress; anxiety; pain; sleep issues; digestive issues; low libido).
Key exclusion criteria (1 listed)
- -Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)- containing consumer productsOils or capsules containing CBD which could be purchased commercially within the U.S. | Dietary supplement | R-101, R-102, R-103, R-104, R-105, R-106, R-107, R-108 |
Primary outcome
Anxiety
Time frame: 60 days
Anxiety score, according to the Generalized Anxiety Disorder (GAD)-7 scale. Scores range from 0 to 21, with higher scores representing more severe anxiety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Generalized Anxiety Disorder, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.