NCT04105231

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Lone Baandrup · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial examines the efficacy of cannabidiol (CBD) versus risperidone for treatment of psychosis in patients with non affective-psychosis and lifetime use of cannabis.

Detailed description

People with psychosis and comorbid cannabis use are particularly difficult to treat because cannabis use worsens psychotic symptoms and increases the risk that a first-episode psychosis will progress to schizophrenia. It is the THC (tetrahydrocannabinol) content in cannabis that aggravates psychotic symptoms whereas the CBD content has potential therapeutic effects. This trial investigates treatment with CBD (without THC) versus risperidone (an antipsychotic agent) in people with psychosis and lifetime use of cannabis. We hypothesize that CBD will ameliorate psychotic symptoms and reduce the frequency of cannabis use to a larger extent than risperidone. Sleep disturbances are often a limiting factor in the treatment of psychosis, and it is also examined how CBD affects objective and subjective sleep quality as well as circadian rest-activity cycles. Based on previous studies investigating CBD as monotherapy in patients with schizophrenia, it is expected that CBD will be associated with fewer adverse events than risperidone.

Conditions

• Dual Diagnosis

Interventions

Type	Name	Description
DRUG	Cannabidiol	Cannabidiol oral suspension
DRUG	Risperidone	Risperidone, encapsulated tablet.

Timeline

• Start date: 2021-06-01
• Primary completion: 2025-11-25
• Completion: 2026-03-31
• First posted: 2019-09-26
• Last updated: 2026-01-27

Locations

1 site across 1 country: Denmark