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

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Neuropathic Pain; Nociceptive Pain
• Intervention / Treatment: Dietary supplement: Relief Study Product Usage

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

• Study Type: Interventional
• Enrollment (Actual): 457
• 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: 21 years to 105 years (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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control 1; Relief Product Form 1 - control	Dietary supplement: Relief Study Product Usage; Participants instructed to use study product daily as directed for a period of 4 weeks
Experimental: Active Product 1.1; Relief Product Form 1 - active product 1	Dietary supplement: Relief Study Product Usage; Participants instructed to use study product daily as directed for a period of 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	4 weeks
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]	4 weeks
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']	4 weeks
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]	4 weeks
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]	4 weeks
Minimal clinically important difference (MCID) in pain interference	Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A	4 weeks
Minimal clinically important difference (MCID) in neuropathic pain	Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A	4 weeks
Minimal clinically important difference (MCID) in nociceptive pain	Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A	4 weeks
Minimal clinically important difference (MCID) in pain intensity	Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in energy (fatigue)	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A [scale 4-20; with higher scores corresponding to greater fatigue]	4 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A [scale 4-20; with higher scores corresponding to greater cognitive function]	4 weeks
Change in emotional distress	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]	4 weeks
Change in sexual interest	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]	4 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): November 22, 2022
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Nociceptive Pain
• Other Study ID Numbers: RADX-22D05

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