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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 below
Select...
I have a family member with a confirmed psychotic disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-30 min, +15 min, +80 min, +150 min, +240 min
This trial's timeline: 3 weeks for screening, Varies for treatment, and -30 min, +15 min, +80 min, +150 min, +240 min for reporting.

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 more

Trial 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

Low Dose THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT02102113 — Phase < 1
Psychosis Research Study Groups: No Family History of Psychosis (FHN), Family History of Psychosis (FHP)
Psychosis Clinical Trial 2023: Low Dose THC Highlights & Side Effects. Trial Name: NCT02102113 — Phase < 1
Low Dose THC (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02102113 — Phase < 1
~1 spots leftby Jun 2025