Status:
ACTIVE_NOT_RECRUITING
Hippocampal Response to Acute Oral Doses of CBD During an fMRI Memory Task
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
Yale University
Conditions:
CBD
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Cannabidiol (CBD) is another cannabis plant derivative for which, like THC, there has been extensive research. Unlike THC however, CBD is non-intoxicating and non-psychedelic. CBD has antipsychotic ef...
Detailed Description
The investigators conjecture that CBD may act both to modify THC effects and to reduce psychosis symptoms (at least in part) through downstream ECS-related mechanisms, both of which actions converge o...
Eligibility Criteria
Inclusion
- 18-50y/o
- Males and females of all races and ethnicities
- Able to provide written informed consent
- Able to read, speak, and understand English
- Meet DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features OR healthy controlled with no diagnosed severe mental illness
- No history of adverse normal baseline values for liver function tests (LFTs)
Exclusion
- Strongly left-handed individuals defined as a 60:40 or greater ratio of left to right hand preference (assessed using the Edinburgh Handedness Inventory)
- Premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest, age-corrected standardized score)
- Comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months
- Neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovascular disorder, AIDS) that may affect central nervous system function
- Concomitant medications that may interact with study drug adversely such as platelet inhibitors, benzodiazepines, or valproate
- Initial detection of abnormal liver function tests or previous medical history of abnormal liver function or liver disease
- Vulnerable populations (e.g., pregnant, nursing, incarcerated); unwilling to use reliable means of contraception
- High risk for suicide defined as more than 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
- Current homicidal ideation with plan and intent such that outpatient care is precluded
- Positive result on breathalyzer or positive urine toxicology test for any substance, including CBD
- History of prior allergic reaction with CBD or CBD-containing products
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04778644
Start Date
December 15 2021
End Date
December 15 2025
Last Update
April 12 2024
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06106