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

October 25, 2021 updated by: Radicle Science

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Rae Wellness PBC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

1350 women from across the United States

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
R-101
CBD oil, 30 mg CBD per serving, 0% THC per serving, medium-chain triglyceride dilution, carbon dioxide extraction method
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
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
Dietary supplement: Cannabidiol (CBD)- containing consumer products
Oils or capsules containing CBD which could be purchased commercially within the U.S.
Control
Waitlist control; no product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radicle Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00054510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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