TY - JOUR

T1 - Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use

T2 - study protocol for a randomized controlled clinical trial

AU - Rasmussen, Jesper Østrup

AU - Jennum, Poul

AU - Linnet, Kristian

AU - Glenthøj, Birte Y.

AU - Baandrup, Lone

N1 - Publisher Copyright: © 2021, The Author(s).

PY - 2021

Y1 - 2021

N2 - Background: Cannabis use is an important risk factor for development of psychosis and further transition to schizophrenia. The prevalence of patients with psychosis and comorbid cannabis use (dual diagnosis) is rising with no approved specialized pharmacological treatment option. Cannabidiol, a constituent of the Cannabis sativa plant, has potential both as an antipsychotic and as a cannabis substituting agent. The aim of this study is to evaluate the efficacy of cannabidiol versus a first-choice second-generation antipsychotic (risperidone) in patients with early psychosis and comorbid cannabis use. Methods: The study is a phase II randomized, double-blinded, parallel-group, active-comparator clinical trial. We plan to include 130 patients aged between 18 and 64 years with a recent diagnosis of psychosis, comorbid cannabis use, and currently not treated with antipsychotics. The participants will be randomized to seven weeks of treatment with either cannabidiol 600 mg (300 mg BID) or risperidone 4 mg (2 mg BID). Participants will undergo clinical assessment after 1, 3, 5 and 7 weeks, telephone assessment the weeks in between, and a safety visit two weeks after end of treatment. The primary outcomes are cessation of cannabis use (self-reported) and psychotic symptom severity. The secondary outcomes include frequency and quantity of cannabis use, global illness severity, psychosocial functioning, subjective well-being, cognition, sleep, circadian rhythmicity, and metabolomics. Discussion: The results of this trial can potentially contribute with a new treatment paradigm for patients suffering from dual diagnosis. Trial registration: ClinicalTrials.gov, NCT04105231, registered April 23rd, 2021

AB - Background: Cannabis use is an important risk factor for development of psychosis and further transition to schizophrenia. The prevalence of patients with psychosis and comorbid cannabis use (dual diagnosis) is rising with no approved specialized pharmacological treatment option. Cannabidiol, a constituent of the Cannabis sativa plant, has potential both as an antipsychotic and as a cannabis substituting agent. The aim of this study is to evaluate the efficacy of cannabidiol versus a first-choice second-generation antipsychotic (risperidone) in patients with early psychosis and comorbid cannabis use. Methods: The study is a phase II randomized, double-blinded, parallel-group, active-comparator clinical trial. We plan to include 130 patients aged between 18 and 64 years with a recent diagnosis of psychosis, comorbid cannabis use, and currently not treated with antipsychotics. The participants will be randomized to seven weeks of treatment with either cannabidiol 600 mg (300 mg BID) or risperidone 4 mg (2 mg BID). Participants will undergo clinical assessment after 1, 3, 5 and 7 weeks, telephone assessment the weeks in between, and a safety visit two weeks after end of treatment. The primary outcomes are cessation of cannabis use (self-reported) and psychotic symptom severity. The secondary outcomes include frequency and quantity of cannabis use, global illness severity, psychosocial functioning, subjective well-being, cognition, sleep, circadian rhythmicity, and metabolomics. Discussion: The results of this trial can potentially contribute with a new treatment paradigm for patients suffering from dual diagnosis. Trial registration: ClinicalTrials.gov, NCT04105231, registered April 23rd, 2021

KW - Antipsychotic medication

KW - Cannabidiol

KW - Cannabis

KW - Dual diagnosis

KW - Psychosis

KW - Randomized clinical trial

KW - Schizophrenia

KW - THC

U2 - 10.1186/s12888-021-03395-9

DO - 10.1186/s12888-021-03395-9

M3 - Journal article

C2 - 34391393

AN - SCOPUS:85112439407

VL - 21

JO - B M C Psychiatry

JF - B M C Psychiatry

SN - 1471-244X

M1 - 404

ER -