What is the mechanism of action of this treatment?

Cannabidiol (CBD) primarily exerts its effects through modulation of the endocannabinoid system, particularly by interacting with cannabinoid receptors (CB1 and CB2) and other neurotransmitter systems. Unlike THC, CBD is non-intoxicating and has been shown to have antipsychotic properties, potentially by opposing the effects of THC. This is significant for patients as CBD can modulate hippocampal activity, which is crucial for memory and cognitive function. These properties make CBD a promising treatment for conditions like schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis, as it may help alleviate psychotic symptoms without the psychoactive effects associated with THC.

What side effects are associated with this type of intervention?

Cannabidiol (CBD) is generally well-tolerated, but it can cause some side effects. Commonly reported adverse effects include dizziness, dry mouth, changes in appetite, and fatigue. In some cases, CBD may also lead to diarrhea and changes in weight. When used as an antipsychotic, CBD's side effects are similar, with additional reports of potential interactions with other medications, which may necessitate careful monitoring by a healthcare provider.

What prior FDA approvals exist?

Cannabidiol (CBD) has been extensively researched for its therapeutic potential, particularly its antipsychotic effects. The FDA has approved Epidiolex, a CBD-based medication, for the treatment of seizures associated with two rare and severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. While CBD's antipsychotic properties are being studied, particularly its effects on the hippocampus in conditions like schizophrenia and bipolar disorder with psychosis, no specific FDA approval has been granted for these indications yet. Research continues to explore CBD's broader therapeutic applications, including its potential as an antipsychotic agent.

What other types of research exist?

Promising novel alternatives to Cannabidiol (CBD) for antipsychotic effects include: 1) Varenicline, which has shown efficacy in smoking cessation without exacerbating symptoms of severe mental illness, 2) Gabapentin, which has demonstrated reduction in cannabis use and improvement in cognitive function, and 3) Sarcosine, which has been suggested for managing schizophrenia. These alternatives are supported by recent studies and may offer new avenues for treatment in 2024.

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Cannabidiol

CBD for Cannabidiol

Phase 1 & 2

Waitlist Available

Led By Godfrey Pearlson, MD

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post drug administration at 3 hours

Summary

This trial is studying CBD, a non-intoxicating cannabis compound, to see if it can help reduce psychosis symptoms in patients with schizophrenia, schizoaffective disorder, or bipolar disorder. CBD works by affecting brain areas involved in mood and perception. Cannabidiol (CBD), a non-psychoactive component of cannabis, shows great promise for the treatment of psychosis and is associated with fewer side effects than conventional antipsychotic drugs.

Who is the study for?

This trial is for adults aged 18-50 with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features, as well as healthy individuals without severe mental illness. Participants must have normal liver function and be able to consent and understand English. Excluded are those allergic to CBD, left-handed individuals (as defined by a specific test), recent substance abusers, those at high risk of suicide or homicide, with certain neurological/medical conditions or on interacting medications.

What is being tested?

The study investigates the effects of CBD versus a placebo on the hippocampus during an fMRI memory task in patients with certain psychiatric disorders compared to healthy controls. It aims to demonstrate whether CBD can engage brain targets related to psychosis and if it has potential antipsychotic properties.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. Since this is a non-intoxicating compound unlike THC from cannabis plants, psychoactive side effects are not expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post drug administration at 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post drug administration at 3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and post drug administration at 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CBD dose-response for fMRI Hippocampal BOLD values

Side effects data

From 2014 Phase 2 trial • 50 Patients • NCT01844687

headache

Blurred Vision

Cold Symptoms

Gastrointestinal Upset

anxiety

100%

80%

60%

40%

20%

Study treatment Arm

Active MJ With 0 mg CBD

Active MJ With 200 mg CBD

Active MJ With 400 mg CBD

Active MJ With 800 mg CBD

Inactive MJ With 0 mg CBD

Inactive MJ With 200 mg CBD

Inactive MJ With 400 mg CBD

Inactive MJ With 800 mg CBD

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with psychosisExperimental Treatment2 Interventions

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.

Group II: Healthy controlsExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBD

2016

Completed Phase 2

~530

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cannabidiol (CBD) primarily exerts its effects through modulation of the endocannabinoid system, particularly by interacting with cannabinoid receptors (CB1 and CB2) and other neurotransmitter systems. Unlike THC, CBD is non-intoxicating and has been shown to have antipsychotic properties, potentially by opposing the effects of THC. This is significant for patients as CBD can modulate hippocampal activity, which is crucial for memory and cognitive function. These properties make CBD a promising treatment for conditions like schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis, as it may help alleviate psychotic symptoms without the psychoactive effects associated with THC.