Cannabidiol for Early Psychosis
(STEP-PROMOTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this trial is:
* To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis.
* To confirm the safety of CBD in individuals at clinical high risk for psychosis.
The trial is a randomised, double-blind, placebo-controlled, multi-centre, international clinical trial. Individuals meeting clinical high risk for psychosis criteria will be recruited for the trial intervention component of the trial. Participants are randomised to treatment with oral CBD 300mg (oral solution 100 mg/mL) twice daily, or a matching placebo, for 104 weeks. By using a battery of clinical outcome assessments, the trial will be able to assess several biomarkers to predict clinical outcomes and response to treatment with CBD. Participants will be invited to provide blood samples, stool samples, cerebrospinal fluid samples (if aged 18 years or over) and complete neuroimaging assessments. Individuals who are not found to have mental illness as defined by DSM-5 criteria will be recruited to a healthy control group, to validate the biomarker component of the trial.
Additionally, a control group of healthy volunteers will be recruited who will not take the trial intervention to aid calibration between datasets from sites acquiring MRI data and to inform and validate any possible multivariate signature associated with the CHR-P state, course or outcome by understanding how these measures are different in controls. Healthy controls will also be used for secondary case-control comparisons. Healthy controls will undergo clinical and biomarker assessments only.
Who Is on the Research Team?
Philip McGuire, PhD, MD
Principal Investigator
University of Oxford
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomised to treatment with oral CBD 300mg twice daily, or a matching placebo, for 104 weeks. Participants will provide various biological samples and complete neuroimaging assessments.
Taper
Participants undergo a 2-week tapering period after the main treatment phase.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including clinical and biomarker evaluations.
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Participants will take the intervention for 106 weeks (104 weeks plus a 2-week taper). Doses depend on age and weight: Adults (16 years and older) over 50kg: daily dose 600mg (6ml); 300mg (3ml) twice a day (b.i.d); Adults (16 years and older) less than 50kg: daily dose 10mg/kg; 5mg/kg twice a day (b.i.d); Children (\<16 years old): daily dose 5mg/kg twice a day (b.i.d), following on from a two-week rapid titration schedule. n=188
A healthy control in the context of this trial is someone who does not meet CHR-P criteria or have a diagnosis of a mental health condition. They will not take the trial intervention and attend one trial visit for clinical assessments and biomarker sampling only. n=150
Participants will take the intervention for 106 weeks (104 weeks plus a 2-week taper). Doses depend on age and weight: Adults (16 years and older) over 50kg: daily dose 600mg (6ml); 300mg (3ml) twice a day (b.i.d). Adults (16 years and older) less than 50kg: daily dose 10mg/kg; 5mg/kg twice a day (b.i.d). Children (\<16 years old): daily dose 5mg/kg twice a day (b.i.d), following on from a two-week rapid titration schedule. n=188
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oxford
Lead Sponsor
Wellcome Trust
Collaborator
Jazz Pharmaceuticals
Industry Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
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