Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05108220
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2021-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Effects of CBD Products on Anxiety Among U.S. Women
Sponsor:
Radicle Science
Organization:
Study Overview
Official Title:
A Retrospective Cohort Study to Evaluate the Effects of Cannabidiol (CBD)-Containing Test Products on Anxiety Among Women in the U.S.
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: