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Cannabidiol

CBD for Cannabidiol

Phase 1 & 2
Recruiting
Led By Godfrey Pearlson, MD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features OR healthy controlled with no diagnosed severe mental illness
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post drug administration at 3 hours
Awards & highlights

Study Summary

This trial is testing whether CBD can help treat psychosis in patients with schizophrenia, schizoaffective disorder, or bipolar disorder, compared to a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, or any other severe mental illness. Or, you are a healthy individual with no diagnosed severe mental illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post drug administration at 3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and post drug administration at 3 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CBD dose-response for fMRI Hippocampal BOLD values

Side effects data

From 2014 Phase 2 trial • 50 Patients • NCT01844687
2%
headache
2%
Blurred Vision
2%
Cold Symptoms
2%
Gastrointestinal Upset
2%
anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active MJ With 0 mg CBD
Active MJ With 200 mg CBD
Active MJ With 400 mg CBD
Active MJ With 800 mg CBD
Inactive MJ With 0 mg CBD
Inactive MJ With 200 mg CBD
Inactive MJ With 400 mg CBD
Inactive MJ With 800 mg CBD

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patients with psychosisExperimental Treatment2 Interventions
People who are part of a dimensionally-organized psychosis sample spanning several serious mental illness diagnoses including schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules.
Group II: Healthy controlsExperimental Treatment2 Interventions
People who do not have a diagnosis of schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBD
2016
Completed Phase 2
~440
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hartford HospitalLead Sponsor
132 Previous Clinical Trials
18,902 Total Patients Enrolled
Yale UniversityOTHER
1,837 Previous Clinical Trials
2,728,393 Total Patients Enrolled
Godfrey Pearlson, MDPrincipal InvestigatorFounding Director Olin Research Center; Professor Yale University
2 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

CBD (Cannabidiol) Clinical Trial Eligibility Overview. Trial Name: NCT04778644 — Phase 1 & 2
Cannabidiol Research Study Groups: Patients with psychosis, Healthy controls
Cannabidiol Clinical Trial 2023: CBD Highlights & Side Effects. Trial Name: NCT04778644 — Phase 1 & 2
CBD (Cannabidiol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04778644 — Phase 1 & 2

Frequently Asked Questions

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

Does the research include any participants aged 85 and above?

"According to the entry requirements for this medical trial, prospective participants must between 18 and 50 years of age."

Answered by AI

What is the cap on the amount of participants in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this study - which was originally listed on December 15th 2021- is currently recruiting patients. 20 participants are needed from a single medical centre before the trial can begin."

Answered by AI

To whom is eligibility for this clinical trial extended?

"This trial seeks 20 individuals aged 18 to 50 who have been diagnosed with cbd. In addition, they must match the diagnostic criteria in DSM-IV (SCID) for schizophrenia, schizoaffective disorder or bipolar I disorder with psychotic features; and be of any gender identity and ethnicity without a severe mental illness."

Answered by AI

Have any further investigations been conducted regarding the efficacy of CBD?

"At this moment, 79 clinical trials involving cannabidiol are active. Of these studies, 16 have reached the third phase of their investigations. These medical examinations take place in cities across Brazil such as Ribeirao Preto and Sao Paulo with a total of 290 locations involved altogether."

Answered by AI

Are there still slots available for study participants?

"According to data on clinicaltrials.gov, this medical research is actively seeking participants. The trial was initially published on December 15th 2021 and has since been updated as recent as August 1st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Hartford Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
~6 spots leftby Mar 2025