Evaluation of Effects of CBD Products on Anxiety Among U.S. Women

Completed

• Conditions: Generalized Anxiety Disorder; Anxiety
• Interventions: Dietary Supplement: Cannabidiol (CBD)- containing consumer products

• Registration Number: NCT05108220
• Lead Sponsor: Radicle Science

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 Timeline

• Study Start: 2020-10-15
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Study First Submitted: 2021-06-04
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Study First Posted: 2021-11-04
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1350

Inclusion Criteria

• 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).

Exclusion Criteria

-Pregnant or breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
R-101	Cannabidiol (CBD)- containing consumer products	CBD oil, 30 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
R-106	Cannabidiol (CBD)- containing consumer products	CBD capsule, 25 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
R-107	Cannabidiol (CBD)- containing consumer products	CBD capsule, 15 mg CBD per serving, \<0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
R-104	Cannabidiol (CBD)- containing consumer products	CBD oil, 20 mg CBD per serving, \<0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
R-108	Cannabidiol (CBD)- containing consumer products	CBD capsule, 25 mg CBD per serving, \<0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method
R-102	Cannabidiol (CBD)- containing consumer products	CBD oil, 20 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
R-103	Cannabidiol (CBD)- containing consumer products	CBD oil, 30 mg CBD per serving, \<0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
R-105	Cannabidiol (CBD)- containing consumer products	CBD capsule, 15 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method

Primary Outcome Measures

Name	Time	Method
Anxiety	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.

Trial Locations

Locations (1)

Rae Wellness PBC; 🇺🇸 Minneapolis, Minnesota, United States