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

Radicle Science

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: Sleep Study Product Usage

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552898

RADX-22D01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,750 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,750 participants in 6 patient groups, including a placebo group

Placebo Control 1

Placebo Comparator group

Description:

Sleep Product Form 1 - control

Treatment:

Dietary Supplement: Sleep Study Product Usage

Active Product 1.1

Experimental group

Description:

Sleep Product Form 1 - active product 1

Treatment:

Dietary Supplement: Sleep Study Product Usage

Active Product 1.2

Experimental group

Description:

Sleep Product Form 1 - active product 2

Treatment:

Dietary Supplement: Sleep Study Product Usage

Active Product 1.3

Experimental group

Description:

Sleep Product Form 1 - active product 3

Treatment:

Dietary Supplement: Sleep Study Product Usage

Active Product 1.4

Experimental group

Description:

Sleep Product Form 1 - active product 4

Treatment:

Dietary Supplement: Sleep Study Product Usage

Active Product 1.5

Experimental group

Description:

Sleep Product Form 1 - active product 5

Treatment:

Dietary Supplement: Sleep Study Product Usage