Radicle Calm 2: A Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Health Outcomes

Radicle™ Calm 2: A Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Other Health Outcomes

A randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes

Study Overview

• Status: Active, not recruiting
• Conditions: Stress; Anxiety
• Intervention / Treatment: Dietary supplement: Placebo Control Form 1; Dietary supplement: Placebo Control Form 2; Dietary supplement: Placebo Control Form 3; Dietary supplement: Placebo Control Form 4; Dietary supplement: Calm Active Study Product 1.1 Usage; Dietary supplement: Calm Active Study Product 1.2 Usage; Dietary supplement: Calm Active Study Product 1.3 Usage; Dietary supplement: Calm Active Study Product 2.1 Usage; Dietary supplement: Calm Active Study Product 3.1 Usage; Dietary supplement: Calm Active Study Product 4.1 Usage

Detailed Description

This is a randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less anxiety or stress, (2) indicate an interest in taking a health and wellness product to potentially help their feelings of anxiety or stress, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

• Study Type: Interventional
• Enrollment (Actual): 3853
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses fewer feelings of anxiety or stress as a primary desire
• Selects feelings of anxiety or stress, looking to improve their feelings of anxiety or stress, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address
• The calculated validated health survey (PRO) measurement result is less than mild severity/impairment
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs (monoamine oxidase inhibitors)
• Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Calm Product Form 1 - control	Dietary supplement: Placebo Control Form 1; Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 2; Calm Product Form 2 - control	Dietary supplement: Placebo Control Form 2; Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 3; Calm Product Form 3 - control	Dietary supplement: Placebo Control Form 3; Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Experimental: Active Product 1.1; Calm Product Form 1 - active product 1	Dietary supplement: Calm Active Study Product 1.1 Usage; Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.
Experimental: Active Product 1.2; Calm Product Form 1 - active product 2	Dietary supplement: Calm Active Study Product 1.2 Usage; Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks.
Experimental: Active Product 1.3; Calm Product Form 1 - active product 3	Dietary supplement: Calm Active Study Product 1.3 Usage; Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 weeks.
Experimental: Active Product 2.1; Calm Product Form 2 - active product 1	Dietary supplement: Calm Active Study Product 2.1 Usage; Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks.
Experimental: Active Product 3.1; Calm Product Form 3 - active product 1	Dietary supplement: Calm Active Study Product 3.1 Usage; Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 4; Calm Product Form 4 - control	Dietary supplement: Placebo Control Form 4; Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Experimental: Active Product 4.1; Calm Product Form 4 - active product 1	Dietary supplement: Calm Active Study Product 4.1 Usage; Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in feelings of anxiety	Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stress	Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)	6 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)	6 weeks
Change in sleep	Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)	6 weeks
Change in mood (emotional distress)	Mean difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)	6 weeks
Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where lower scores correspond to less interest in sexual activity)	6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)	6 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): April 26, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RADX-2302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No