Cannabidiol oral solution for Psychosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
UC San Diego, La Jolla, CAPsychosisCannabidiol oral solution - Drug
Eligibility
16 - 30
All Sexes
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Study Summary

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

Eligible Conditions
  • Early Psychosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: Week 7

7 weeks
Body Mass Index
Cortisol
Eating Behavior
Baseline and week 7
Cholesterol
Electrophysiology - Prepulse Inhibition
Electrophysiology Mismatch Negativity
Week 7
Clinical Global Impression Scale (CGI-S)
Positive and Negative Symptoms of Psychosis
Prodromal Symptoms
week 7
General Symptoms
Neurocognition
Inflammation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Cannabidiol Augmentation
1 of 2
Placebo Augmentation
1 of 2

Experimental Treatment

Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: Cannabidiol oral solution · Has Placebo Group · Phase 3

Cannabidiol Augmentation
Drug
Experimental Group · 1 Intervention: Cannabidiol oral solution · Intervention Types: Drug
Placebo Augmentation
Drug
PlaceboComparator Group · 1 Intervention: Cannabidiol oral solution · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 7

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,036 Previous Clinical Trials
1,825,433 Total Patients Enrolled
3 Trials studying Psychosis
277 Patients Enrolled for Psychosis
Center for Medicinal Cannabis ResearchOTHER
16 Previous Clinical Trials
463 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

Eligibility Criteria

Age 16 - 30 · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)," - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.