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

NCT ID: NCT05108220

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2020-12-30

Brief Summary

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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

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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

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Anxiety Generalized Anxiety Disorder

Keywords

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Cannabidiol Tetrahydrocannabinol Anxiety Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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R-101

CBD oil, 30 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-102

CBD oil, 20 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-103

CBD oil, 30 mg CBD per serving, \<0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-104

CBD oil, 20 mg CBD per serving, \<0.3% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-105

CBD capsule, 15 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-106

CBD capsule, 25 mg CBD per serving, 0% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-107

CBD capsule, 15 mg CBD per serving, \<0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

R-108

CBD capsule, 25 mg CBD per serving, \<0.3% THC per serving, Rice Powder and Piperine dilution, carbon dioxide extraction method

Cannabidiol (CBD)- containing consumer products

Intervention Type DIETARY_SUPPLEMENT

Oils or capsules containing CBD which could be purchased commercially within the U.S.

Control

Waitlist control; no product

No interventions assigned to this group

Interventions

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Cannabidiol (CBD)- containing consumer products

Oils or capsules containing CBD which could be purchased commercially within the U.S.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radicle Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rae Wellness PBC

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00054510

Identifier Type: -

Identifier Source: org_study_id