Cannabidiol versus risperidone for treatment of recent-onset psychosis with comorbid cannabis use: study protocol for a randomized controlled clinical trial

Abstract

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

Required elements for an educational programme for lay exercise instructors in charge of community-based exercise targeting young adults with schizophrenia spectrum disorders – A stakeholder focus group study

“…The study was conducted as part of the development and design of the Vega trial which aims to evaluate the effectiveness of a gym-based exercise programme delivered by non-health professional exercise instructors for young adults receiving antipsychotic medication [24]. The current study applied a descriptive qualitative design using researcher triangulation and semi-structured focus groups.…”

“…The educational elements identified and communicated in the Findings section were adapted and integrated into an educational programme for lay exercise instructors delivering community-based exercise targeting young adults. The educational programme is currently implemented and evaluated as a part of the Vega trial [24] and encompasses (1) a written exercise instructor manual; (2) a one-day educational course; and (3) continuous exchange of experiences between instructors. Appendix 2 provides an overview of the educational programme with headlines on the educational content.…”

Efficacy of cannabinoids in neurodevelopmental and neuropsychiatric disorders among children and adolescents: a systematic review

“…A small trial of intravenous THC is underway to evaluate the efficacy of CBD for adults with psychosis [65], adults with early psychosis and comorbid cannabis use [119], and young people (aged 18-35 years) at high risk for psychosis [115]. There are no trials of medicinal use of CBP for children/adolescents with psychosis.…”

Measuring functional outcomes in schizophrenia in an increasingly digital world

“…Encouraged by meaningful results and good levels of adherence and engagement, larger-scale studies using a variety of active and passive measures related to functioning have been launched (e.g. Begemann et al, 2020 ; Bilderbeck et al, 2019 ; Rasmussen et al, 2021 ) and will help to get a better sense of clinical validity of such measures.…”