Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Dual Diagnosis Clinical Trial

Official title:

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04105231
• Other study ID #: CBD-P
• Secondary ID: 2018-004893-84
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: University of Copenhagen
• Contact: Lone Baandrup, MD, PhD
• Phone: 30270879
• Email: lone.baandrup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dual Diagnosis
• Marijuana Abuse
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Cannabidiol
Cannabidiol oral suspension
• Risperidone
Risperidone, encapsulated tablet.

Locations

Country	Name	City	State
Denmark	Center for Neuropsychiatric Schizophrenia Research	Glostrup

Sponsors (5)

Lead Sponsor	Collaborator
Lone Baandrup	Copenhagen University Hospital, Denmark, Danish Center for Sleep Medicine, Glostrup University Hospital, Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events (AEs), discontinuation due to AEs, and serious adverse events (SAEs)	Self-report	From baseline to 2 weeks after end of treatment
Other	Extrapyramidal and other side effects	Udvalget for Kliniske Undersoegelser (UKU) short version A clinician-rated scale to assess antipsychotic side effects	7 weeks follow-up
Primary	Psychotic symptoms	Positive and Negative Syndrome Scale (PANSS) positive subscale, range 7-49. A measure of symptom severity. Higher values are worse.	7 weeks follow-up
Secondary	Cannabis cessation (no use of cannabis within the past two weeks) (for current cannabis users at baseline)	Timeline follow back method	7 weeks follow-up
Secondary	Cannabis use by self-reported days of cannabis use per week, since last study visit.	Timeline follow back method	7 weeks follow-up
Secondary	Amount of cannabis use per day, self-reported, since last study visit.	PSYSCAN cannabis questionnaire# 6-8	7 weeks follow-up
Secondary	Response	Response defined by PANSS total 25 percentile changes	7 weeks follow-up
Secondary	Remission	Symptomatic remission is defined according to the Andreasen et al remission criteria. The criteria define symptomatic remission as a rating of no more than mild in four core positive and four core negative symptoms on the Positive and Negative Syndrome Scale (P1, P2 P3, N1, N4, N6, G5, G9,) that is sustained for =6 months. Because of the duration of this study, the requirement of 6 month will not be considered.	7 weeks follow-up
Secondary	Global illness severity	Global illness severity is assessed with the Clinical Global Impression Scale (CGI). We will use the severity (CGI-S) at baseline and improvement (CGI-I) scores of the CGI at the following visits. Response will be defined as much improved or better on the CGI-I. The main item 'severity of illness' is measured on a 7-point Likert scale (from 1 'normal, not at all ill' to 7 'among the most extremely ill patients').	7 weeks follow-up
Secondary	Psychosocial functioning	Personal and Social Performance Scale (PSP). Higher is better, range 1-100.	7 weeks follow-up
Secondary	Neurocognitive functioning	Brief Assessment of Cognition in Schizophrenia (BACS). Neurocognitive Test Battery. One composite score and six subscales.	7 weeks follow-up
Secondary	Subjective well-being	Subjective Well-being under Neuroleptics Scale (SWN). A measure of health-related quality of life.	7 weeks follow-up
Secondary	Circadian rest-activity cycle	Actigraphy. A wrist-worne device that measures kinetic energy.	7 weeks follow-up
Secondary	Subjective sleep quality	Pittsburgh Sleep Quality Index (PSQI). One total score, seven subscales.	7 weeks follow-up
Secondary	Objective sleep evaluation	Polysomnography (PSG). A measure of objective sleep variables	7 weeks follow-up
Secondary	Metabolomics	Markers for cannabinoids, dopamine and serotonin and their precursors and metabolites in the blood	7 weeks follow-up