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THC

Phase 1

Behavioral Pharmacology of Cannabinoids | Small molecule | Other |Canopy Growth Corporation|Trials Updated: Oct 8, 2024

THC development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

THC clinical trials

THC · 1 trial · 1 indication

Early Phase 1 1
NCT05478863The Pharmacodynamics of Cannabinoid-Caffeine CombinationsBehavioral Pharmacology of Cannabinoids
COMPLETED20 Analytics
EARLY_PHASE1COMPLETED
The Pharmacodynamics of Cannabinoid-Caffeine Combinations
Behavioral Pharmacology of Cannabinoids
NCT0547886320
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Study Endpoints

Primary Endpoints

Change in Driving Performance on the DRiving Under the Influence of Drugs (DRUID®)
0-, 30-, 90-, 150-, 170-, 240-, 360-, and 480- minutes post drug administration

Driving Performance as Measured by the DRiving Under the Influence of Drugs (DRUID®) behavioral task. Higher scores = greater impairment.

Driving Performance on the Driving Simulator
170-minutes post drug administration

Driving Performance as Measured by a Driving Simulator task

Secondary Endpoints

Change in subjective feelings of energy
0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of alertness
0-, 30-, 90-, 150-minutes post drug administration
Change in subjective feelings of focus
0-, 30-, 90-, 150-minutes post drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Oral placeboPLACEBO_COMPARATORAcute administration of oral placebo three times in study session (Time 0, 60, and 120).
Oral administration of 2.5 mg THCEXPERIMENTALAcute administration of oral THC (2.5 mg) three times in study session (Time 0, 60, and 120).
Oral administration of 2.5 mg THC + 60 mg caffeineEXPERIMENTALAcute administration of oral THC (2.5 mg) and oral caffeine (60 mg) three times in study session (Time 0, 60, and 120).
Oral administration of 2.5 mg THC + 60 mg caffeine + 35 mg CBDEXPERIMENTALAcute administration of oral THC (2.5 mg), oral caffeine (60 mg), and oral CBD (35 mg) three times in study session (Time 0, 60, and 120).

Interventions

NameTypeDescription
Oral PlaceboDRUGPlacebo will be orally self-administered by study participants.
Oral THCDRUGTHC will be orally self-administered by study participants.
Oral CBDDRUGCBD will be orally self-administered by study participants.
Oral CaffeineDRUGCaffeine will be orally self-administered by study participants.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Person is between 18 and 55-years-old (inclusive). 2. Person has a body mass index (BMI) between 18 and 35 Kg/m\^2 (inclusive). 3. Person is willing and able to provide informed consent. 4. Person has consumed cannabis products containing THC in the past. 5. Person has consum...

Countries:United States
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