NCT05003882

Brief Summary

A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

July 23, 2021

Last Update Submit

March 24, 2022

Conditions

PainSleep DisturbanceAnxiety

Outcome Measures

Primary Outcomes (3)

  • Greater increase in overall well-being from baseline

    Overall well-being as assessed by KEMP Quality of Life Scale (QOL scale 1-7 where 7 is a better QOL)

    4 weeks

  • Improvement in overall well-being from baseline

    Overall well-being as assessed by World Health Organization (WHO) 5 Well Being Index (0-5 where 5 is better well-being)

    4 weeks

  • Change in overall well-being from baseline

    Overall well-being as assessed by Patient Global Impression of Change (PGIC statement selection much improved to much worse)

    4 weeks

Secondary Outcomes (7)

  • Improvement in sleep from baseline

    4 weeks

  • Change in sleep from baseline

    4 weeks

  • Change in anxiety from baseline

    4 weeks

  • Less anxiety from baseline

    4 weeks

  • Decrease in anxiety from baseline

    4 weeks

  • +2 more secondary outcomes

Study Arms (14)

Arm A

Commercially available, orally ingestible CBD product A

Other: Commercially available, orally ingestible CBD product

Arm B

Commercially available, orally ingestible CBD product B

Other: Commercially available, orally ingestible CBD product

Arm C

Commercially available, orally ingestible CBD product C

Other: Commercially available, orally ingestible CBD product

Arm D

Commercially available, orally ingestible CBD product D

Other: Commercially available, orally ingestible CBD product

Arm E

Commercially available, orally ingestible CBD product E

Other: Commercially available, orally ingestible CBD product

Arm F

Commercially available, orally ingestible CBD product F

Other: Commercially available, orally ingestible CBD product

Arm G

Commercially available, orally ingestible CBD product G

Other: Commercially available, orally ingestible CBD product

Arm H

Commercially available, orally ingestible CBD product H

Other: Commercially available, orally ingestible CBD product

Arm I

Commercially available, orally ingestible CBD product I

Other: Commercially available, orally ingestible CBD product

Arm J

Commercially available, orally ingestible CBD product J

Other: Commercially available, orally ingestible CBD product

Arm K

Commercially available, orally ingestible CBD product K

Other: Commercially available, orally ingestible CBD product

Arm L

Commercially available, orally ingestible CBD product L

Other: Commercially available, orally ingestible CBD product

Arm M

Commercially available, orally ingestible CBD product M

Other: Commercially available, orally ingestible CBD product

Control

Waitlist control

Interventions

Commercially available, orally ingestible CBD productOTHER

botanically-derived CBD extract product

Arm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm KArm LArm M

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults (21 yo and older) living in the USA

You may qualify if:

  • Participants must be 21 years of age
  • Live in the USA
  • Endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a CBD product
  • Must have regular access to a computer, mobile device, and/or the internet to complete surveys

You may not qualify if:

  • A person pregnant, trying to become pregnant or breastfeeding
  • Anyone diagnosed with liver disease or considered a heavy drinker
  • Anyone taking medication that warns against grapefruit consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radicle Science

Encinitas, California, 92024, United States

Location

MeSH Terms

Conditions

PainParasomniasAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Kelsey Laird, PhD

    Radicle Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 13, 2021

Study Start

August 2, 2021

Primary Completion

October 30, 2021

Study Completion

December 31, 2021

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

only aggregated and anonymized data will be shared.

Locations

US(1)