Using cannabidiol to treat psychosis in cannabis users
Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
This study tests whether cannabidiol (CBD) can help people with psychosis who use cannabis feel better and have fewer side effects than the usual medication, risperidone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Glostrup) |
| Trial ID | NCT04105231 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of cannabidiol (CBD) compared to risperidone in treating psychosis among individuals with a history of cannabis use. It focuses on patients diagnosed with non-affective psychosis, exploring how CBD may alleviate psychotic symptoms and reduce cannabis consumption. The study also examines the impact of CBD on sleep quality and circadian rhythms, as sleep disturbances are common in psychosis treatment. The hypothesis is that CBD will result in fewer side effects than risperidone while providing therapeutic benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with a diagnosis of non-affective psychosis and a history of cannabis use.
Not a fit: Patients with treatment-resistant psychosis or those dependent on substances other than cannabis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for managing psychosis in patients who also use cannabis.
How similar studies have performed: Previous studies have shown promising results for CBD in treating psychosis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * ICD-10 diagnosis of schizophrenia (DF20.X), paranoid psychosis (DF22.X), acute/intermittent psychotic disorder (DF23.X), schizoaffective psychosis (DF25.X), other/not specified nonorganic psychotic disorder (DF28/DF29), or cannabis induced psychotic disorder (DF12.5) * PANSS ≥ 60 and score of ≥ 4 on ≥ 2 PANSS-Positive subscale items: Delusions (P1), conceptual disorganization (P2), hallucinatory behaviour (P3), grandiosity (P5), suspiciousness (P6) * Lifetime cannabis use * Age 18-45 years * Female patients of childbearing potential need to utilize a proper method of contraception Exclusion criteria: * Treatment resistance as defined by treatment (ever) with clozapine * Dependence syndrome of alcohol or psychoactive substances other than cannabis (DF1X.2 other than DF12.2) * Psychotic disorder induced by alcohol or psychoactive substances other than cannabis (DF1X.5 other than DF12.5) * Treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections) * Treatment with an oral antipsychotic within the past 7 days * Use of self-administered CBD products during the trial * Patients involuntarily admitted * Pregnancy or lactation * Severe physical illness that might influence the ability to comply with the protocol
Where this trial is running
Glostrup
- Center for Neuropsychiatric Schizophrenia Research — Glostrup, Denmark (Recruiting)
Study contacts
- Principal investigator: Lone Baandrup, MD, PhD — Mental Health Services Capital Region in Denmark
- Study coordinator: Lone Baandrup, MD, PhD
- Email: lone.baandrup@regionh.dk
- Phone: 30270879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.