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CBD

Phase 1

Cannabis, Drug Effects | Small molecule | Other |Canopy Growth Corporation|Trials Updated: Aug 7, 2024

CBD development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Feb 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

CBD clinical trials

CBD · 1 trial · 1 indication

Phase 1 1
NCT04283019The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure ConditionsCannabis, Drug Effects
COMPLETED75 Analytics
PHASE1COMPLETED
The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure Conditions
Cannabis, Drug EffectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Urine cannabinoids
Day 1, 2, 7, 14, and 21

Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)

Secondary Endpoints

Subjective drug effects as assessed by the Drug Effect Questionnaire
Day 1
Blood cannabinoids
Day 1, 2, 7, 14, and 21
Oral Fluid cannabinoids
Day 1, 2, 7, 14, and 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
CBD without THCEXPERIMENTALoral formulation containing 100mg CBD and 0mg THC
CBD with 3.7 mg THCEXPERIMENTALoral formulation containing 100mg CBD and 3.7mg THC
CBD with 2.8 mg THCEXPERIMENTALoral formulation containing 100mg CBD and 2.8 mg THC

Interventions

NameTypeDescription
CBDDRUGCBD will be orally ingested
THCDRUGTHC will be orally ingested
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Have provided written informed consent 2. Be between the ages of 18 and 55 3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests 4. Test negative for recent cannabis use in urine at the screening visit ...

Countries:United States
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