## Protocol Section
### Identification Module
**NCT ID:** NCT06431074

**Brief Title:** Radicle Calm 24: A Study of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes

**Official Title:** Radicle Calm™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes

#### Organization Study ID Info
**ID:** RADX-P-2402
#### Organization
**Class:** INDUSTRY
**Full Name:** Radicle Science
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Radicle Science

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes

**Detailed Description:** This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) endorse a desire for less feelings of anxiety (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at 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.

### Conditions Module

**Conditions:**

- Anxiety

- Stress

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Participants will be stratified based on gender at birth, then randomized to one of the study arms

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Calm Product Form 1 - control

**Intervention Names:**

- Dietary Supplement: Placebo Control Form 1

**Label:** Placebo Control 1

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Calm Product Form 1 - active product 1

**Intervention Names:**

- Dietary Supplement: Calm Active Study Product 1.1 Usage

**Label:** Active Product 1.1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Placebo Control 1

**Description:** Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

**Name:** Placebo Control Form 1

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Active Product 1.1

**Description:** Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.

**Name:** Calm Active Study Product 1.1 Usage

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Other Outcomes

**Description:** Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only). Potentially include saliva-based biomarkers (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP).

**Measure:** Change in concentration of at-home (direct-to-consumer) specimen assay (saliva)

**Time Frame:** 6 weeks

**Description:** Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only). Potentially include blood-based biomarkers (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB).

**Measure:** Change in concentration of at-home (direct-to-consumer) specimen assay (blood)

**Time Frame:** 6 weeks

**Description:** Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only). Potentially include stool sample (microbial diversity). Units of measure will vary depending upon biospecimen collected.

**Measure:** Optional Change in concentration of at-home (direct-to-consumer) specimen assays (stool)

**Time Frame:** 6 weeks

#### Primary Outcomes

**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)

**Measure:** Change in feelings of anxiety

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** Mean difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)

**Measure:** Change in stress

**Time Frame:** 6 weeks

**Description:** Mean difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)

**Measure:** Change in sleep

**Time Frame:** 6 weeks

**Description:** Mean difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)

**Measure:** Change in mood (emotional distress)

**Time Frame:** 6 weeks

**Description:** Likelihood of achieving a MCID in sleep disturbance, as measured by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)

**Measure:** Minimal clinically important difference (MCID) in feelings of anxiety

**Time Frame:** 6 weeks

**Description:** Likelihood of experiencing minimal clinically important difference in stress score as assessed by Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)

**Measure:** Minimal clinically important difference (MCID) in stress

**Time Frame:** 6 weeks

**Description:** Likelihood of experiencing minimal clinically important difference in sleep score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)

**Measure:** Minimal clinically important difference (MCID) in sleep

**Time Frame:** 6 weeks

**Description:** Likelihood of experiencing minimal clinically important difference in mood score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)

**Measure:** Minimal clinically important difference (MCID) in mood (emotional distress)

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
* Resides in the United States
* Endorses less anxiety as a primary desire
* Has the opportunity for at least 20% improvement in their primary health outcome
* 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 and mobile phone number
* Reports current enrollment in another clinical trial
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensive, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
* Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
* Lack of reliable daily access to the internet

**Healthy Volunteers:** True

**Maximum Age:** 105 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** studymgmt@radiclescience.com

**Name:** Study Manager

**Phone:** 760-281-3898

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Del Mar

**Country:** United States

**Facility:** Radicle Science, Inc

**State:** California

**Zip:** 92014

#### Overall Officials

**Official 1:**

**Affiliation:** Radicle Science, Inc

**Name:** Emily K. Pauli, PharmD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Data will not be shared with researchers outside of Radicle Collaborators on this study.

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Radicle Science, Inc

**URL:** http://radiclescience.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
