Clinical trial NCT05552898: Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
Official title: Radicle™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 1750
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sleep disturbance
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in sleep quantity
timeFrame: 4 weeks
measure: Change in overall well-being
timeFrame: 4 weeks
measure: Change in anxiety
timeFrame: 4 weeks
measure: Change in pain
timeFrame: 4 weeks
measure: Achievement of minimum clinically important difference (MCID) in sleep disturbance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Del Mar
country: United States
facility: Radicle Science, Inc
state: California
Study officials:
affiliation: Radicle Science, Inc
name: Emily K Pauli, PharmD
role: PRINCIPAL_INVESTIGATOR
References: