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

NCT05552898 | Completed

• 1 other identifier: RADX-22D01
• Study Type: interventional
• Target: 1,750
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 \[T-score mapping\])

  4 weeks

Secondary Outcomes (5)

• Change in sleep quantity

  4 weeks

• Change in overall well-being

  4 weeks

• Change in anxiety

  4 weeks

• Change in pain

  4 weeks

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

  4 weeks

Study Arms (6)

Placebo Control 1

PLACEBO COMPARATOR

Sleep Product Form 1 - control

Dietary Supplement: Sleep Study Product Usage

Active Product 1.1

EXPERIMENTAL

Sleep Product Form 1 - active product 1

Dietary Supplement: Sleep Study Product Usage

Active Product 1.2

EXPERIMENTAL

Sleep Product Form 1 - active product 2

Dietary Supplement: Sleep Study Product Usage

Active Product 1.3

EXPERIMENTAL

Sleep Product Form 1 - active product 3

Dietary Supplement: Sleep Study Product Usage

Active Product 1.4

EXPERIMENTAL

Sleep Product Form 1 - active product 4

Dietary Supplement: Sleep Study Product Usage

Active Product 1.5

EXPERIMENTAL

Sleep Product Form 1 - active product 5

Dietary Supplement: Sleep Study Product Usage

Interventions

Sleep Study Product Usage DIETARY_SUPPLEMENT

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

Active Product 1.1; Active Product 1.2; Active Product 1.3; Active Product 1.4; Active Product 1.5; Placebo Control 1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

Study Officials

• Emily K Pauli, PharmD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on gender and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: March 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: August 26, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)