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Cannabidiol oral solution for Psychosis

Phase 3
Waitlist Available
Led By Kristin Cadenhead, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 7
Awards & highlights

Study Summary

This trial is testing whether adding CBD to current treatment for psychosis can improve symptoms, cognition, and inflammation.

Eligible Conditions
  • Early Psychosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Global Impression Scale (CGI-S)
General Symptoms
Neurocognition
+2 more
Secondary outcome measures
Cortisol
Inflammation
Other outcome measures
Body Mass Index
Cholesterol
Eating Behavior
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol AugmentationExperimental Treatment1 Intervention
The cannabidiol will be administered as an oral solution to be mixed in any fluid. The formulation is 100 mg/ml. It will be administered at 500 mg at bedtime X 1 week then 500 mg BID.
Group II: Placebo AugmentationPlacebo Group1 Intervention
Placebo will appear identical to the cannabidiol solution

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,515 Total Patients Enrolled
3 Trials studying Psychosis
277 Patients Enrolled for Psychosis
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
509 Total Patients Enrolled
Kristin Cadenhead, MDPrincipal Investigator - University of California, San Diego
University of California, San Diego
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Psychosis
120 Patients Enrolled for Psychosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the individuals in this research project restricted to those over 30 years old?

"This trial is looking for enrollees between the ages of 16-30. In contrast, there are 130 similar studies available for patients under 18 and 329 for those above 65."

Answered by AI

Are people still being accepted into the trial program?

"Yes, this is an ongoing recruitment according to the information detailed on clinicaltrials.gov. The listing for this trial was created on July 1st 2021 and edited June 4th 2021."

Answered by AI

What is the FDA's opinion on Cannabidiol oral solution?

"Cannabidiol oral solution has received a Phase 3 designation, meaning that while there is some efficacy data available, the primary focus is on safety."

Answered by AI

How large is the scope of this clinical trial?

"That is correct. The online information regarding this study confirms that it is still recruiting patients. This particular trial was first advertised on July 1st, 2021 and the most recent update was June 4th, 2021. They are looking for a total of 120 individuals at 2 locations."

Answered by AI

What are some other examples of research done on Cannabidiol oral solution?

"83 different clinical trials are currently underway to study the effects of Cannabidiol oral solution. This includes 18 Phase 3 trials. While many of these studies hail from Ribeirao Preto and Sao Paulo, 311 locations worldwide are participating in research for Cannabidiol oral solution."

Answered by AI

What are the requirements to become a participant in this clinical trial?

"This trial is looking for 120 individuals, all of whom must meet the following criteria: Aged between 16 and 30, currently have a mental disorder, clinically stable for at least 2 months, first episode psychosis participants will have been maintained on current antipsychotic for at least 6 weeks with no change in antipsychotic dose for the previous 4 weeks while APS participants will be on the same treatment regimen (psychosocial or pharmacologic) for 4 weeks, exhibit no more than moderate levels of positive symptoms (defined by ratings of ≤ 4) on PANSS items P1 (delusions), P2 (conceptual disorganization),"

Answered by AI
~32 spots leftby Apr 2025