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

Primary Purpose

Anxiety, Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Calm Active Study Product 1.1 Usage
Calm Active Study Product 1.2 Usage
Calm Active Study Product 1.3 Usage
Placebo Control Form 1
Placebo Control Form 2
Calm Active Study Product 2.1 Usage
Placebo Control Form 3
Calm Active Study Product 3.1 Usage
Placebo Control Form 4
Calm Active Study Product 4.1 Usage
Sponsored by
Radicle Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radicle Science, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo Control 1

Active Product 1.1

Active Product 1.2

Active Product 1.3

Placebo Control 2

Active Product 2.1

Placebo Control 3

Active Product 3.1

Placebo Control 4

Active Product 4.1

Arm Description

Calm Product Form 1 - control

Calm Product Form 1 - active product 1

Calm Product Form 1 - active product 2

Calm Product Form 1 - active product 3

Calm Product Form 2 - control

Calm Product Form 2 - active product 1

Calm Product Form 3 - control

Calm Product Form 3 - active product 1

Calm Product Form 4 - control

Calm Product Form 4 - active product 1

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)

Full Information

First Posted
April 6, 2023
Last Updated
October 20, 2023
Sponsor
Radicle Science
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1. Study Identification

Unique Protocol Identification Number
NCT05837910
Brief Title
Radicle Calm 2: A Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Health Outcomes
Official Title
Radicle™ Calm 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Other Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radicle Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes
Detailed Description
This is a randomized, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking
ParticipantInvestigator
Masking Description
Participants will be blinded to the product they receive.
Allocation
Randomized
Enrollment
3667 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control 1
Arm Type
Placebo Comparator
Arm Description
Calm Product Form 1 - control
Arm Title
Active Product 1.1
Arm Type
Experimental
Arm Description
Calm Product Form 1 - active product 1
Arm Title
Active Product 1.2
Arm Type
Experimental
Arm Description
Calm Product Form 1 - active product 2
Arm Title
Active Product 1.3
Arm Type
Experimental
Arm Description
Calm Product Form 1 - active product 3
Arm Title
Placebo Control 2
Arm Type
Placebo Comparator
Arm Description
Calm Product Form 2 - control
Arm Title
Active Product 2.1
Arm Type
Experimental
Arm Description
Calm Product Form 2 - active product 1
Arm Title
Placebo Control 3
Arm Type
Placebo Comparator
Arm Description
Calm Product Form 3 - control
Arm Title
Active Product 3.1
Arm Type
Experimental
Arm Description
Calm Product Form 3 - active product 1
Arm Title
Placebo Control 4
Arm Type
Placebo Comparator
Arm Description
Calm Product Form 4 - control
Arm Title
Active Product 4.1
Arm Type
Experimental
Arm Description
Calm Product Form 4 - active product 1
Intervention Type
Dietary Supplement
Intervention Name(s)
Calm Active Study Product 1.1 Usage
Intervention Description
Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calm Active Study Product 1.2 Usage
Intervention Description
Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calm Active Study Product 1.3 Usage
Intervention Description
Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control Form 1
Intervention Description
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control Form 2
Intervention Description
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calm Active Study Product 2.1 Usage
Intervention Description
Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control Form 3
Intervention Description
Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calm Active Study Product 3.1 Usage
Intervention Description
Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control Form 4
Intervention Description
Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calm Active Study Product 4.1 Usage
Intervention Description
Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in feelings of anxiety
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in stress
Description
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)
Time Frame
6 weeks
Title
Change in cognitive function
Description
Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)
Time Frame
6 weeks
Title
Change in sleep
Description
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)
Time Frame
6 weeks
Title
Change in mood (emotional distress)
Description
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)
Time Frame
6 weeks
Title
Change in libido
Description
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)
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in feelings of anxiety
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager
Phone
760-281-3898
Email
studymgmt@radiclescience.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily K. Pauli, PharmD
Organizational Affiliation
Radicle Science, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radicle Science, Inc
City
Del Mar
State/Province
California
ZIP/Postal Code
92014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Management
Phone
760-281-3898
Email
studymgmt@radiclescience.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared with researchers outside of Radicle Collaborators on this study.
Links:
URL
http://radiclescience.com
Description
Radicle Science, Inc

Learn more about this trial

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

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