Clinical trial NCT04105231: Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
Official title: Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dual Diagnosis
Keywords: psychosis
cannabis
clinical trial
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Center for Sleep Medicine
name: Copenhagen University Hospital, Denmark
name: Glostrup University Hospital, Copenhagen
name: University of Copenhagen
First posted: 2019-09-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Psychotic symptoms
timeFrame: 7 weeks follow-up
Secondary outcomes:
measure: Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)
timeFrame: 7 weeks follow-up
measure: Cannabis use by self-reported days of cannabis use per week, since last study visit.
timeFrame: 7 weeks follow-up
measure: Amount of cannabis use per day, self-reported, since last study visit.
timeFrame: 7 weeks follow-up
measure: Response
timeFrame: 7 weeks follow-up
measure: Remission
timeFrame: 7 weeks follow-up
measure: Global illness severity
timeFrame: 7 weeks follow-up
measure: Psychosocial functioning
timeFrame: 7 weeks follow-up
measure: Neurocognitive functioning
timeFrame: 7 weeks follow-up
measure: Subjective well-being
timeFrame: 7 weeks follow-up
measure: Circadian rest-activity cycle
timeFrame: 7 weeks follow-up
measure: Subjective sleep quality
timeFrame: 7 weeks follow-up
measure: Objective sleep evaluation
timeFrame: 7 weeks follow-up
measure: Metabolomics
timeFrame: 7 weeks follow-up
Other outcomes:
measure: Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs)
timeFrame: From baseline to 2 weeks after end of treatment
measure: Extrapyramidal and other side effects
timeFrame: 7 weeks follow-up
Locations:
city: Glostrup
country: Denmark
facility: Center for Neuropsychiatric Schizophrenia Research
Study officials:
affiliation: Mental Health Services Capital Region in Denmark
name: Lone Baandrup, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen JO, Jennum P, Linnet K, Glenthoj BY, Baandrup L. Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2021 Aug 14;21(1):404. doi: 10.1186/s12888-021-03395-9.