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Cannabinoid
THC for Psychosis Risk
Phase < 1
Waitlist Available
Led By Mohini Ranganathan, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Having one relative with a confirmed psychotic disorder
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -30 min, +240 min
Summary
This trial is testing whether people with a family history of psychosis react differently to THC than controls without a family history of psychosis.
Who is the study for?
This trial is for people who have tried cannabis at least once and are medically and mentally healthy. They must also have a relative with a confirmed psychotic disorder. It's not specified who can't join, but typically those with health issues that could interfere would be excluded.
What is being tested?
The study aims to see if having a family history of psychosis affects how the body responds to THC, an active component of cannabis. Participants will receive either very low dose THC, low dose THC, or a placebo without knowing which one they're getting.
What are the potential side effects?
While the document doesn't list specific side effects, typical reactions to THC may include altered senses or sense of time, mood changes, impaired body movement, difficulty thinking and problem-solving.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a family member with a confirmed psychotic disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ -30 min, +15 min, +80 min, +150 min, +240 min
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-30 min, +15 min, +80 min, +150 min, +240 min
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Secondary study objectives
Clinician Administered Dissociative Symptoms Scale (CADSS)
Hopkins Verbal Learning Test (HVLT)
Psychotomimetic States Inventory (PSI)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: No Family History of Psychosis (FHN)Experimental Treatment3 Interventions
Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.
Group II: Family History of Psychosis (FHP)Experimental Treatment3 Interventions
Individuals with a family member with a confirmed diagnosis of psychosis. They will receive the placebo, very low dose THC, and low dose THC interventions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,437 Total Patients Enrolled
6 Trials studying Psychosis
3,035 Patients Enrolled for Psychosis
Mohini Ranganathan, MDPrincipal InvestigatorYale University
4 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a family member with a confirmed psychotic disorder.
Research Study Groups:
This trial has the following groups:- Group 1: No Family History of Psychosis (FHN)
- Group 2: Family History of Psychosis (FHP)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.