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Marijuana

Phase 1

Schizophrenia | Small molecule | Psychiatry |Harvard Bioscience, Inc.|Last Updated: Dec 9, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment263
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01964404Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?PHASE1 COMPLETED 263Jul 1, 2014Sep 18, 2021Dec 9, 20252 United States
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Study Endpoints
Primary Endpoints
Brain Reward Circuit Activation on fMRI Scan
3 hours

Activation of the Brain Reward Circuit (particularly the nucleus accumbens) in anticipation of monetary reward. The 'Measure' is a mean of the Fisher-Z transform of the inter-regional correlation measured for each participant between the nucleus accumbens and anterior cingulate cortex. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences. A Fisher-Z transform of '0' represents a value of '0' for the estimated correlation, which represents no correlation in the activity time series between the regions. The values reflect strengths of functional connectivity between brain regions that can be compared between groups (e.g. Healthy controls and SCZ-CUD groups who received different study drugs). Means and standard deviations similar to healthy controls would be considered a good outcome.

Resting State Connectivity Within the Brain Reward Circuitry
1 hour after smoking study drug, 3 hours after oral dronabinol

Resting state connectivity within brain reward circuitry as measured with the Fisher-transformed r value of the connectivity maps between the nucleus accumbans and other brain areas. The Fisher-transformation creates a normally distributed correlation value for statistical analyses assessing between group differences (smoked THC vs placebo; oral dronabinol vs placebo)

Secondary Endpoints
PANSS Positive Symptoms
3 hours after oral THC/placebo
PANSS Negative Symptoms
3 hours after oral THC/placebo
Cognitive Functioning, Verbal Learning
4 hours after oral drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Marijuana cigarette and placebo capsuleEXPERIMENTAL3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Dronabinol and placebo cigaretteEXPERIMENTALDronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI.
Placebo cigarette and placebo capsulePLACEBO_COMPARATORPlacebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI.
Interventions
NameTypeDescription
MarijuanaDRUGSmoked plant with THC
DronabinolDRUGCapsule with THC
PlaceboDRUGCapsule with no active ingredient
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Groups 1-3 Participants with schizophrenia and a cannabis use disorder 1. Ages 18 - 55 years 2. Diagnosis of schizophrenia 3. Diagnosis of cannabis abuse or dependence 4. Use of cannabis within the month prior to screening 5. Willing to remain abstinent for the 14 days before t...

Countries:United States
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