Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
9 participants
INTERVENTIONAL
2025-12-01
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Occasional Users - High THC and High CBD Dose
People who smoke marijuana occasionally will be given a dose of high THC high CBD marijuana at the study visit
High THC/High CBD Marihuana
high THC (65 mg THC) and high CBD (50 mg CBD)
Occasional Users - High THC and No CBD Dose
People who smoke marijuana occasionally will be given a dose of high THC and no CBD marijuana at the study visit
High THC/No CBD Marihuana
high THC (65 mg THC) and no CBD (0 mg CBD)
Occasional Users - No THC and No CBD Dose
People who smoke marijuana occasionally will be given a dose of marijuana that contains no THC or CBD
No THC/No CBD Marihuana
no THC (0 mg THC) and no CBD (0 mg CBD); placebo drug
Interventions
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High THC/No CBD Marihuana
high THC (65 mg THC) and no CBD (0 mg CBD)
High THC/High CBD Marihuana
high THC (65 mg THC) and high CBD (50 mg CBD)
No THC/No CBD Marihuana
no THC (0 mg THC) and no CBD (0 mg CBD); placebo drug
Eligibility Criteria
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Inclusion Criteria
* Prior MJ users (has used MJ at least once in the past year, but no more than 1x/month in the past 12 months)
* Medically healthy (as determined by medical history and treatment)
* Adequate comprehension of English in order to complete study materials
* Acceptable birth control method for women (i.e., no copper IUD or any device that is not MRI safe)
Exclusion Criteria
* Psychiatric diagnoses (determined by DSM-V)
* Participant heavily or regularly uses MJ (more than 1x/month in the past year)
* Current or past substance dependence (including MJ)
* Positive urine toxicology screens
* Positive pregnancy screens
* MRI contraindications (e.g., heart pacemaker)
18 Years
40 Years
ALL
Yes
Sponsors
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Yale University
OTHER
Hartford Hospital
OTHER
Responsible Party
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Godfrey Pearlson
Founding Director Olin Neuropsychiatry Research Center; Professor Yale University
Principal Investigators
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Godfrey Pearlson, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital - Olin Neuropsychiatry Research Center; Yale University
Alecia Dager, PhD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital - Olin Neuropsychiatry Research Center; Yale University
Michael Stevens, PhD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital - Olin Neuropsychiatry Research Center
Central Contacts
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Other Identifiers
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126663
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R-HHC-2019-0137
Identifier Type: -
Identifier Source: org_study_id
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