Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo Control Form 1 Capsules

Health Active Study Product 1.1 Capsules

Health Active Study Product 1.2 Capsules

Health Active Study Product 1.3 Capsules

About this trial

This is an interventional other trial for Sleep

Eligibility Criteria

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

Inclusion Criteria: 21 years of age and older Resides in the United States Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue) Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study Exclusion Criteria: Reports being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid physical shipping address and mobile phone number Reports a diagnosis of liver or kidney disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Reports current enrollment in a clinical trial The QOL score greater than 5 during enrollment Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Sites / Locations

Radicle Science, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Control 1 Capsules

Active Product 1.1 Capsules

Active Product 1.2 Capsules

Active Product 1.3 Capsules

Arm Description

Health Product Form 1 Capsules - control

Health Product Form 1 Capsules - active product 1

Health Product Form 1 Capsules - active product 2

Health Product Form 1 Capsules - active product 3

Outcomes

Primary Outcome Measures

Change in overall health-related quality of life

Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)

Secondary Outcome Measures

Change in physical function

Mean difference in physical function score as assessed by PROMIS PROPr items related to physical function (scale 4-20; with higher scores corresponding to greater physical function)

Change in feelings of anxiety

Mean difference in feelings of anxiety score as assessed by PROMIS PROPr items related to anxiety (scale 4-20; with higher scores corresponding to more severe feelings of anxiety)

Change in feelings of depression

Mean difference in feelings of depression score as assessed by PROMIS PROPr items related to depression (scale 4-20; with higher scores corresponding to more severe feelings of depression)

Change in fatigue

Mean difference in fatigue score as assessed by PROMIS PROPr questions related to fatigue (scale 4-20; with higher scores corresponding to more severe fatigue)

Change in sleep disturbance

Mean difference in sleep disturbance score as assessed by PROMIS PROPr items related to sleep disturbance (scale 4-20; with higher scores corresponding to greater sleep disturbance)

Change in socialization ability

Mean difference in socialization ability score as assessed by PROMIS PROPr items related to (scale 4-20; with higher scores corresponding to greater ability to participate in social roles and activities)

Change in pain

Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain)

Change in cognitive function

Mean difference in cognitive function score as assessed by PROMIS PROPr items related to cognitive function (scale 2-10; with higher scores corresponding to greater cognitive function)

Change in libido

Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater interest in sexual activities)

Minimal clinical importance difference (MCID) in overall health-related quality of life

Likelihood of achieving a MCID in overall health-related quality of life, as measured by PROMIS PROPr (scale 70-120; with higher scores corresponding to greater overall health-related quality of life)

Full Information

NCT ID

NCT05783232

First Posted

March 8, 2023

Last Updated

October 23, 2023

Sponsor

Radicle Science

1. Study Identification

Unique Protocol Identification Number

NCT05783232

Brief Title

Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

Official Title

Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 21, 2023 (Actual)

Primary Completion Date

June 9, 2023 (Actual)

Study Completion Date

October 27, 2023 (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 of health and wellness product formulations and their effects on overall health

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 better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, 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 will be collected electronically from eligible participants over 5 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

Sleep, Pain, Depression, Anxiety

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 arm

Masking

ParticipantInvestigator

Masking Description

Participants will be blinded to the product they receive.

Allocation

Randomized

Enrollment

1494 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Control 1 Capsules

Arm Type

Placebo Comparator

Arm Description

Health Product Form 1 Capsules - control

Arm Title

Active Product 1.1 Capsules

Arm Type

Experimental

Arm Description

Health Product Form 1 Capsules - active product 1

Arm Title

Active Product 1.2 Capsules

Arm Type

Experimental

Arm Description

Health Product Form 1 Capsules - active product 2

Arm Title

Active Product 1.3 Capsules

Arm Type

Experimental

Arm Description

Health Product Form 1 Capsules - active product 3

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Control Form 1 Capsules

Intervention Description

Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Health Active Study Product 1.1 Capsules

Intervention Description

Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Health Active Study Product 1.2 Capsules

Intervention Description

Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Health Active Study Product 1.3 Capsules

Intervention Description

Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.

Primary Outcome Measure Information:

Title

Change in overall health-related quality of life

Description

Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change in physical function

Description

Mean difference in physical function score as assessed by PROMIS PROPr items related to physical function (scale 4-20; with higher scores corresponding to greater physical function)

Time Frame

4 weeks

Title

Change in feelings of anxiety

Description

Mean difference in feelings of anxiety score as assessed by PROMIS PROPr items related to anxiety (scale 4-20; with higher scores corresponding to more severe feelings of anxiety)

Time Frame

4 weeks

Title

Change in feelings of depression

Description

Mean difference in feelings of depression score as assessed by PROMIS PROPr items related to depression (scale 4-20; with higher scores corresponding to more severe feelings of depression)

Time Frame

4 weeks

Title

Change in fatigue

Description

Mean difference in fatigue score as assessed by PROMIS PROPr questions related to fatigue (scale 4-20; with higher scores corresponding to more severe fatigue)

Time Frame

4 weeks

Title

Change in sleep disturbance

Description

Mean difference in sleep disturbance score as assessed by PROMIS PROPr items related to sleep disturbance (scale 4-20; with higher scores corresponding to greater sleep disturbance)

Time Frame

4 weeks

Title

Change in socialization ability

Description

Mean difference in socialization ability score as assessed by PROMIS PROPr items related to (scale 4-20; with higher scores corresponding to greater ability to participate in social roles and activities)

Time Frame

4 weeks

Title

Change in pain

Description

Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain)

Time Frame

4 weeks

Title

Change in cognitive function

Description

Mean difference in cognitive function score as assessed by PROMIS PROPr items related to cognitive function (scale 2-10; with higher scores corresponding to greater cognitive function)

Time Frame

4 weeks

Title

Change in libido

Description

Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater interest in sexual activities)

Time Frame

4 weeks

Title

Minimal clinical importance difference (MCID) in overall health-related quality of life

Description

Likelihood of achieving a MCID in overall health-related quality of life, as measured by PROMIS PROPr (scale 70-120; with higher scores corresponding to greater overall health-related quality of life)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

105 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 21 years of age and older Resides in the United States Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue) Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study Exclusion Criteria: Reports being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid physical shipping address and mobile phone number Reports a diagnosis of liver or kidney disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Reports current enrollment in a clinical trial The QOL score greater than 5 during enrollment Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

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

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

Sleep, Pain, Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial