NCT04778644

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 on the hippocampus, a region rich in CB1 receptors. As such, observing hippocampus activity levels using fMRI can be an effective means of measuring CBD target engagement within this pilot study context. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug cannabidiol (CBD) versus placebo, in BSNIP Biotype 3 compared to Biotypes 1 and 2 and to healthy control subjects, during performance of an fMRI paired associated memory task. Here, investigators will use B-SNIP-based observations in already-characterized B-SNIP subjects, to predict in which individuals CBD engages a theoretically-based brain target. In turn (in future planned studies) such engagement may predict CBD treatment responders. At present, CBD is still an experimental drug for psychosis treatment (although now FDA-approved for treatment of specific types of childhood seizures), but one with a rather benign side-effect profile that could easily be added to ongoing antipsychotic treatment. The purpose of the study is to study response to a single, acute dose of CBD compared to placebo, under double-blind conditions in a small-scale pilot study.

Conditions

• CBD

Interventions

Type	Name	Description
DRUG	CBD	Oral gel capsule CBD
DRUG	Placebo	Oral gel capsule placebo

Timeline

• Start date: 2021-12-15
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2021-03-03
• Last updated: 2024-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study