Cannabidiol for Psychosis

Recruiting at 1 trial location

Overseen By Kristin Cadenhead

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Diego

Must be taking: Antipsychotics

Must not be taking: Azelastine, Dronabinol, Valproic Acid

Disqualifiers: Neurological illness, Head injury, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral Solution (CBD) or with a matching CBD placebo for 8 weeks. The study will examine CBD as an augmentation strategy in early psychosis. It is hypothesized that CBD will improve symptoms, neurocognition, markers of inflammation and eating behaviors. Importantly, moderators and mediators of the CBD effects will be explored.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you need treatment with Azelastine, Fluticasone, Dronabinol, Valproic Acid, or Divalproex Sodium.

What data supports the effectiveness of the drug Cannabidiol Oral Solution for psychosis?

Research suggests that cannabidiol (CBD) may help reduce symptoms of psychosis, such as stress and anxiety, and is generally well-tolerated compared to traditional antipsychotic medications. Some studies indicate that CBD could be effective in treating both positive and negative symptoms of psychosis, and it may also help with neurocognitive issues. ^{1 2 3 4 5}

How is the drug cannabidiol different from other treatments for psychosis?

Cannabidiol (CBD) is unique because it is a component of cannabis that may have antipsychotic effects without causing intoxication, unlike THC, another cannabis component. It also has a more favorable side effect profile compared to traditional antipsychotic medications and may help modulate brain signaling in a way that reduces psychotic symptoms. ^{1 2 3 6 7}

Research Team

Kristin Cadenhead, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for adolescents and adults with early psychosis or related conditions, stable on treatment for at least 8 weeks. They must have mild symptoms, not be at high suicide risk, not pregnant or likely to become so without contraception, and free from substance abuse including THC/CBD.

Inclusion Criteria

My symptoms like delusions or hallucinations are not severe.

My diagnosis is one of the following: APS, psychosis, schizophreniform, schizophrenia, or schizoaffective.

I've been stable on my current psychosis treatment for at least 8 weeks.

Exclusion Criteria

I have another serious illness besides cancer.

You recently had a serious head injury.

High suicidal risk assessed by the The Columbia-Suicide Severity Rating Scale (C-SSRS)42

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either Cannabidiol Oral Solution (CBD) or placebo as an add-on to antipsychotic medication in an 8-week double-blind trial

8 weeks

Pre-treatment, midpoint (week 4), and post-treatment (week 8) testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Cannabidiol Oral Solution

Trial Overview The study tests if Cannabidiol (CBD) oral solution improves symptoms of psychosis when added to standard treatment compared to a placebo. Participants are randomly assigned CBD or placebo for 8 weeks in a double-blind setup where neither they nor the researchers know who gets what.

Participant Groups

Group I: Cannabidiol Augmentation Experimental Treatment 1 Intervention

The cannabidiol will be administered as an oral solution to be mixed in any fluid. The formulation is 100 mg/ml. It will be administered at 500 mg at bedtime X 1 week then 500 mg BID.

Group II: Placebo Augmentation Placebo Group 1 Intervention

Placebo will appear identical to the cannabidiol solution

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Center for Medicinal Cannabis Research

Collaborator

Trials

19

Recruited

630+

Findings from Research

A survey of 70 patients with psychotic disorders revealed that 86% were willing to try cannabidiol (CBD) as a treatment, indicating a high level of acceptability among this group.

Most patients believed that CBD could improve their symptoms and have fewer side effects compared to traditional antipsychotic medications, suggesting that CBD may be a promising alternative treatment option for psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of cannabidiol in patients with psychosis. Chesney, E., Lamper, D., Lloyd, M., et al.[2023]

This study is evaluating the efficacy of cannabidiol (600 mg) compared to risperidone (4 mg) in treating early psychosis in 130 patients who also use cannabis, aiming to assess both psychotic symptoms and cannabis cessation over a seven-week period.

The trial's outcomes could lead to new treatment options for patients with dual diagnosis of psychosis and cannabis use, as current pharmacological treatments are lacking for this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial. Rasmussen, JØ., Jennum, P., Linnet, K., et al.[2023]

A qualitative study involving 15 youth in Early Psychosis Intervention programs revealed that most participants used CBD for reasons like pain relief and relaxation, often viewing it as a safer alternative to THC.

Despite their positive perceptions of CBD, many users were unaware of potential health risks, highlighting the need for education on the benefits and risks of CBD use among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives toward cannabidiol (CBD) among youth in Early Psychosis Intervention programs: A qualitative study. Ghelani, A.[2023]

In a study involving 32 clinical high-risk for psychosis (CHR) patients and 26 healthy controls, CBD treatment (600 mg/day) showed an intermediate effect on cortisol reactivity to stress compared to placebo, suggesting potential benefits in managing stress responses in CHR patients.

While CBD did not significantly differ from placebo in cortisol reactivity, it indicated a trend towards normalizing stress responses, highlighting the need for further research on CBD's effects on anxiety and psychosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term cannabidiol treatment on response to social stress in subjects at clinical high risk of developing psychosis. Appiah-Kusi, E., Petros, N., Wilson, R., et al.[2022]

A clinical trial involving 120 individuals with early psychosis will investigate the effectiveness of 1000 mg of cannabidiol (CBD) as an adjunct treatment over 8 weeks, focusing on symptoms and neurocognition.

Preliminary evidence suggests that CBD may improve positive symptoms of psychosis and potentially help with negative symptoms and cognitive function, while being well tolerated compared to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol versus placebo as adjunctive treatment in early psychosis: study protocol for randomized controlled trial. Dixon, T., Cadenhead, KS.[2023]

A single oral dose of 600 mg of cannabidiol significantly increased hippocampal glutamate levels and reduced symptom severity in 13 patients with psychosis, indicating its potential antipsychotic effects.

The study suggests a link between increased glutamate levels and decreased psychotic symptoms, providing new insights into how cannabidiol may work in the brain to alleviate psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol modulation of hippocampal glutamate in early psychosis. O'Neill, A., Annibale, L., Blest-Hopley, G., et al.[2022]

Cannabidiol (CBD), a component of cannabis, may have antipsychotic properties that could help in treating psychosis, despite cannabis use being linked to an increased risk of developing such conditions.

A targeted literature review of various studies, including animal and human research, indicates that CBD shows promise as a potential treatment for psychotic symptoms and disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a potential treatment for psychosis. Schubart, CD., Sommer, IE., Fusar-Poli, P., et al.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Acceptability of cannabidiol in patients with psychosis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Perspectives toward cannabidiol (CBD) among youth in Early Psychosis Intervention programs: A qualitative study. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of short-term cannabidiol treatment on response to social stress in subjects at clinical high risk of developing psychosis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cannabidiol versus placebo as adjunctive treatment in early psychosis: study protocol for randomized controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol modulation of hippocampal glutamate in early psychosis. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cannabidiol as a potential treatment for psychosis. [2014]