Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

Sponsor

Radicle Science (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511818

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

30.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

Condition or Disease	Intervention/Treatment	Phase
Rest	Dietary Supplement: Rest Study Product Usage	N/A

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 better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption 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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be stratified based on gender at birth then randomized to one of the study armsParticipants will be stratified based on gender at birth then randomized to one of the study arms

Masking:

Single (Participant)

Masking Description:

Participants will be blinded to the product they receive.

Primary Purpose:

Other

Official Title:

Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

Anticipated Study Start Date :

Aug 31, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Control 1 Rest Product Form 1 - control	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Comparator: Placebo Control 2 Rest Product Form 2 - control	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Comparator: Placebo Control 3 Rest Product Form 3 - control	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.1 Rest Product Form 1 - active product 1	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.2 Rest Product Form 1 - active product 2	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.3 Rest Product Form 1 - active product 3	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.4 Rest Product Form 1 - active product 4	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 2.1 Rest Product Form 2 - active product 1	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 2.2 Rest Product Form 2 - active product 2	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 3.1 Rest Product Form 3 - active product 1	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 3.2 Rest Product Form 3 - active product 2	Dietary Supplement: Rest Study Product Usage Participants will use their Radicle Rest study product as directed for a period of 4 weeks.

Outcome Measures

Primary Outcome Measures

Change in sleep quality [4 weeks]
Mean difference in sleep quality score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 1-5; where lower score is less sleep disturbance)

Secondary Outcome Measures

Change in overall well-being [4 weeks]
Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 1-5 where 1 is worse)
Change in overall quality of life (QOL) [4 weeks]
Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; where 1 is worse)
Change in anxiety [4 weeks]
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 1-5; where 1 is less anxiety)
Change in pain [4 weeks]
Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10 where 0 is no pain)
Change in stress [4 weeks]
Mean difference in stress score as assessed by PROMIS Stress 4A (scale 1-5; where 1 is less stress)
Change in fatigue [4 weeks]
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 1-5; where 1 is less fatigue)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

21 years of age and older
Resides in the United States
Endorses a desire for better sleep
Selects sleep as a primary reason for taking a cannabinoid product
Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion Criteria:

Pregnant, trying to become pregnant, or breastfeeding
Reports a diagnosis of liver 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 any medication that warns against grapefruit consumption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radicle Science, Inc	Del Mar	California	United States	92014

Sponsors and Collaborators

Radicle Science

Investigators

Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Radicle Science, Inc

Publications

None provided.

Responsible Party:

Radicle Science

ClinicalTrials.gov Identifier:

NCT05511818

Other Study ID Numbers:

RADX-22D03

First Posted:

Aug 23, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 23, 2022