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

Radicle Science

Status: Completed

Conditions: Sleep Disorder; Sleep Disturbance; Sleep

Treatments: Dietary Supplement: Rest Study Product Usage

Study type: Interventional

Funder types: Industry

Identifiers

NCT05511818

RADX-22D03

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,679 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 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,679 participants in 13 patient groups, including a placebo group

Placebo Control 1

Placebo Comparator group

Description:

Rest Product Form 1 - control

Treatment:

Dietary Supplement: Rest Study Product Usage

Placebo Control 2

Placebo Comparator group

Description:

Rest Product Form 2 - control

Treatment:

Dietary Supplement: Rest Study Product Usage

Placebo Control 3

Placebo Comparator group

Description:

Rest Product Form 3 - control

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 1.1

Experimental group

Description:

Rest Product Form 1 - active product 1

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 1.2

Experimental group

Description:

Rest Product Form 1 - active product 2

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 1.3

Experimental group

Description:

Rest Product Form 1 - active product 3

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 1.4

Experimental group

Description:

Rest Product Form 1 - active product 4

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 2.1

Experimental group

Description:

Rest Product Form 2 - active product 1

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 2.2

Experimental group

Description:

Rest Product Form 2 - active product 2

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 3.1

Experimental group

Description:

Rest Product Form 3 - active product 1

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 3.2

Experimental group

Description:

Rest Product Form 3 - active product 2

Treatment:

Dietary Supplement: Rest Study Product Usage

Placebo Control 4

Placebo Comparator group

Description:

Rest Product Form 4 - control

Treatment:

Dietary Supplement: Rest Study Product Usage

Active Product 4

Experimental group

Description:

Rest Product Form 4 - active product 1

Treatment:

Dietary Supplement: Rest Study Product Usage