Hippocampal Response to Acute Oral Doses of CBD During an fMRI Memory Task

NCT04778644 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HHC-2020-0367
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 effects. Logically, if CBD opposes THC effects, it may be a potential antipsychotic treatment. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug (CBD versus placebo) in patients who have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychosis compared to healthy controls.

Conditions

CBD

Keywords

CBD; Memory; MRI

Outcome Measures

Primary Outcomes (1)

• CBD dose-response for fMRI Hippocampal BOLD values

  Primary outcome of fMRI-measured hippocampus BOLD values during memory recall task

  Post drug administration at 3 hours

Study Arms (2)

Patients with psychosis

EXPERIMENTAL

People who are part of a dimensionally-organized psychosis sample spanning several serious mental illness diagnoses including schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules.

Drug: CBD; Drug: Placebo

Healthy controls

EXPERIMENTAL

People who do not have a diagnosis of schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules.

Drug: CBD; Drug: Placebo

Interventions

CBD DRUG

Oral gel capsule CBD

Also known as: CBD Oil, Food grade CBD

Healthy controls; Patients with psychosis

Placebo DRUG

Oral gel capsule placebo

Also known as: Placebo CBD

Healthy controls; Patients with psychosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• y/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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Yale University: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Study Officials

• Godfrey Pearlson, MD

  Founding Director Olin Research Center; Professor Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Model Details: All subjects will receive both the study drug and placebo.

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)