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Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

Primary Purpose

Pain, Nociceptive Pain, Neuropathic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Relief Study Product Usage

About this trial

This is an interventional other trial for Pain

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 pain as a primary issue (desire for less pain)
Selects their desire for less pain 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 physical shipping address
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
Lack of reliable daily access to the internet
Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs
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 Type

Placebo Comparator

Experimental

Arm Label

Control 1

Active Product 1.1

Arm Description

Relief Product Form 1 - control

Relief Product Form 1 - active product 1

Outcomes

Primary Outcome Measures

Change in pain interference

Mean difference in pain interference score as assessed by Patient Reported Outcome Measurement System (PROMIS) Pain Interference 6A [scale 6-30; with higher scores corresponding to greater pain interference]

Secondary Outcome Measures

Change in neuropathic pain

Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A [scale 5-25; with higher scores corresponding to greater neuropathic pain]

Change in nociceptive pain

Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A [scale 5-25; with higher scores corresponding to greater nociceptive pain]

Change in pain intensity

Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A [scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain']

Change in feelings of anxiety

Mean difference in anxiety score as assessed by PROMIS Anxiety 4A [scale 4-20; with higher scores corresponding to more severe anxiety]

Change in sleep disturbance

Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A [scale 4-20; with higher scores corresponding to more severe sleep disturbance]

Minimal clinically important difference (MCID) in pain interference

Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A

Minimal clinically important difference (MCID) in neuropathic pain

Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A

Minimal clinically important difference (MCID) in nociceptive pain

Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A

Minimal clinically important difference (MCID) in pain intensity

Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A

Full Information

NCT ID

NCT05589935

First Posted

October 18, 2022

Last Updated

October 23, 2023

Sponsor

Radicle Science

1. Study Identification

Unique Protocol Identification Number

NCT05589935

Brief Title

Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

Official Title

Radicle Relief 1™: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

November 22, 2022 (Actual)

Primary Completion Date

December 23, 2022 (Actual)

Study Completion Date

May 24, 2023 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes

Detailed Description

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help relieve their pain, 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 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

Pain, Nociceptive Pain, Neuropathic Pain

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

457 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control 1

Arm Type

Placebo Comparator

Arm Description

Relief Product Form 1 - control

Arm Title

Active Product 1.1

Arm Type

Experimental

Arm Description

Relief Product Form 1 - active product 1

Intervention Type

Dietary Supplement

Intervention Name(s)

Relief Study Product Usage

Intervention Description

Participants instructed to use study product daily as directed for a period of 4 weeks

Primary Outcome Measure Information:

Title

Change in pain interference

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change in neuropathic pain

Description

Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A [scale 5-25; with higher scores corresponding to greater neuropathic pain]

Time Frame

4 weeks

Title

Change in nociceptive pain

Description

Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A [scale 5-25; with higher scores corresponding to greater nociceptive pain]

Time Frame

4 weeks

Title

Change in pain intensity

Description

Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A [scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain']

Time Frame

4 weeks

Title

Change in feelings of anxiety

Description

Mean difference in anxiety score as assessed by PROMIS Anxiety 4A [scale 4-20; with higher scores corresponding to more severe anxiety]

Time Frame

4 weeks

Title

Change in sleep disturbance

Description

Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A [scale 4-20; with higher scores corresponding to more severe sleep disturbance]

Time Frame

4 weeks

Title

Minimal clinically important difference (MCID) in pain interference

Description

Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A

Time Frame

4 weeks

Title

Minimal clinically important difference (MCID) in neuropathic pain

Description

Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A

Time Frame

4 weeks

Title

Minimal clinically important difference (MCID) in nociceptive pain

Description

Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A

Time Frame

4 weeks

Title

Minimal clinically important difference (MCID) in pain intensity

Description

Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Change in energy (fatigue)

Description

Mean difference in fatigue score as assessed by PROMIS Fatigue 4A [scale 4-20; with higher scores corresponding to greater fatigue]

Time Frame

4 weeks

Title

Change in cognitive function

Description

Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A [scale 4-20; with higher scores corresponding to greater cognitive function]

Time Frame

4 weeks

Title

Change in emotional distress

Description

Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A [scale 4-20; with higher scores corresponding to greater levels of emotional distress]

Time Frame

4 weeks

Title

Change in sexual interest

Description

Mean difference in sexual interest as assessed by PROMIS Sexual Interest 2.0 [scale 2-10; with higher scores corresponding to greater interest in sexual activity]

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: 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 pain as a primary issue (desire for less pain) Selects their desire for less pain 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 physical shipping address 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 Lack of reliable daily access to the internet Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs 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

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 Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

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