Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

Radicle Science1,750 enrolled

Overview

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

The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study. After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

1,750

Conditions

Sleep

Interventions

Sleep Study Product UsageDIETARY_SUPPLEMENT

Participants will use their Radicle Sleep 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 symptoms of sleep disturbance * Selects sleep disturbance 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

Sleep disturbance as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance SF 8A (Scoring from 8 to 40, with higher scores translating to greater sleep disturbance. Scores are standardized to US general population \[T-score mapping\])

Time frame: 4 weeks

Secondary Outcomes

Change in sleep quantity

Sleep quantity as assessed by average hours of sleep reported per night

Time frame: 4 weeks

Change in overall well-being

Change in well-being as assessed by World Health Organization 5 (WHO-5 scale; Scoring from 0 to 25, with higher scores translating to greater well-being)

Time frame: 4 weeks

Change in anxiety

Anxiety as assessed by PROMIS Anxiety 4A (Scoring from 4 to 20, with higher scores translating to greater anxiety. Scores are standardized to US general population \[T-score mapping)\]

Time frame: 4 weeks

Change in pain

Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)

Time frame: 4 weeks

Achievement of minimum clinically important difference (MCID) in sleep disturbance

Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A

Time frame: 4 weeks

Data from ClinicalTrials.gov

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