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

Radicle Science2,679 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

2,679

Conditions

Sleep Sleep Disturbance Sleep Disorder

Interventions

Rest Study Product UsageDIETARY_SUPPLEMENT

Participants will use their Radicle Rest study product as directed for a period of 4 weeks.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 105 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Radicle Science, Inc

Del Mar, California, United States

Outcomes

Primary Outcomes

Change in sleep disturbance

Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)

Time frame: 4 weeks

Secondary Outcomes

Change in overall well-being

Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 0-25; with 0 representing the worst imaginable well-being and 25 representing the best imaginable well-being)

Time frame: 4 weeks

Change in overall quality of life (QOL)

Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL)

Time frame: 4 weeks

Change in anxiety

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

Change in pain

Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10; with 0 representing no pain and 10 representing the worst pain imaginable that completely interferes with enjoyment of life and general activities)

Time frame: 4 weeks

Change in stress

Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)

Time frame: 4 weeks

Change in fatigue

Data from ClinicalTrials.gov

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