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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RECRUITING
PHASE2
10 participants
INTERVENTIONAL
2025-07-01
2027-12-31
Brief Summary
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Detailed Description
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On an initial Screening Visit, regular or novice cannabis (CNB) users will undergo informed consent, clinical assessment (to fully evaluate inclusion/exclusion criteria), cognitive/personality assessment, and a structural MRI scan.
At each assessment, subjects will provide subjectively-rated CNB intoxication using a verbal analog scale, complete 2 fMRI paradigms within \~1.5 hours: a) Card Guessing task and b) Complex Working Memory Span, and complete the computer-based Effort Expenditure for Reward Task within \~2 hours. These tests will be counterbalanced across subjects and sessions to minimize order and fatigue effects. Breaks will be standardized in a private environment and snacks/meals provided. Bathroom visits given as needed. Subjects will be supervised at all times by study staff and vital signs monitored. On assessment days, participants will remain at the Olin NRC until they report no subjective intoxication, and are observed by study staff to be no longer objectively intoxicated, then use taxi or Uber transportation home.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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THC then Placebo
Participants in this arm will receive THC then placebo in a 2-session per subject double-blind, random assignment, placebo-controlled counterbalanced design. (Participants randomized to receive THC in the first session will receive placebo at the 2nd session.) Sessions will be scheduled at least one week apart. Tasks tapping each of the major cognitive memory-related domains will be performed in the MRI scanner, to reveal the relevant underlying circuitry and its disruption by drug using functional MRI.
THC
Participants will be administered 0.5g of vaporized THC cannabis (12% THC cannabis)
Placebo
Participants will be administered identical plant material from which all THC has been removed by solvent extraction.
Placebo then THC
Participants in this arm will receive placebo then THC in a 2-session per subject double-blind, random assignment, placebo-controlled counterbalanced design. (Participants randomized to receive placebo in the first session will receive THC at the 2nd session.) Sessions will be scheduled at least one week apart. Tasks tapping each of the major cognitive memory-related domains will be performed in the MRI scanner, to reveal the relevant underlying circuitry and its disruption by drug using functional MRI.
THC
Participants will be administered 0.5g of vaporized THC cannabis (12% THC cannabis)
Placebo
Participants will be administered identical plant material from which all THC has been removed by solvent extraction.
Interventions
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THC
Participants will be administered 0.5g of vaporized THC cannabis (12% THC cannabis)
Placebo
Participants will be administered identical plant material from which all THC has been removed by solvent extraction.
Eligibility Criteria
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Inclusion Criteria
* Able to read, speak, and understand English.
* Able and willing to provide written informed consent, and willing to commit to the study protocol.
Exclusion Criteria
* Positive screen for drug or alcohol (except CNB) on test day will result in rescheduling the appointment
* History of adverse effects with CNB
* CNB users who are abstaining
* IQ \<80 on the Wechsler Abbreviated Scale of Intelligence
* Inability to comprehend written instructions using the WRAT 4 reading achievement test
* Pregnant, breastfeeding, and ineffective birth control methods
* Unable or unsafe to have an MRI
* Serious medical, neuro-ophthalmological, or neurological illness (e.g. cancer, seizure disorders, encephalopathy
* History of head trauma with loss of consciousness \> 30 minutes or concussion lasting 30 days
* Focal brain lesion seen on structural MRI
* Any medical/neurological condition that could compromise neurocognitive performance (e.g. epilepsy, multiple sclerosis, fetal alcohol syndrome)
* Anyone deemed unsafe to study personnel for any reason
* Hearing loss such that subject cannot hear sounds at the levels (dB) or pitches (Hz) to be used in the study
* Significant pain and/or reduced mobility in the arms
18 Years
75 Years
ALL
No
Sponsors
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Biopharmaceutical Research Company
UNKNOWN
Bloom Labs Cannabis Solutions
UNKNOWN
Yale University
OTHER
Responsible Party
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Godfrey Pearlson
Professor of Psychiatry and of Neuroscience
Principal Investigators
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Godfrey Pearlson, M.D
Role: PRINCIPAL_INVESTIGATOR
Founding Director, Olin Neuropsychiatry Center; Yale University
Locations
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Olin Neuropsychiatric Research Center at Hartford Healthcare
Hartford, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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HHC-2024-0186
Identifier Type: OTHER
Identifier Source: secondary_id
2000032428
Identifier Type: -
Identifier Source: org_study_id
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