- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102113
Probing the Cannabinoid System in Individuals With a Family History of Psychosis
August 4, 2023 updated by: Mohini Ranganathan, Yale University
The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system.
This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system.
We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
21
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria FHP:
- Exposure to cannabis at least once in their lifetime
- Medically and psychiatrically healthy based on screening
- Having one relative with a confirmed psychotic disorder
Exclusion Criteria FHP:
- Current or lifetime major DSM-IV Axis I disorder
- Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
- Major or unstable medical illness that might impact safety of the subject in the study
- Cannabis naive
- IQ less than 85
- Less than a high school diploma or its educational equivalent
- Pregnancy or lactation
- Major current or recent (<6 weeks) psychosocial stressors.
Inclusion Criteria FHN :
- Exposure to cannabis at least once in their lifetime
- Medically and psychiatrically healthy based on screening
Exclusion Criteria FHN:
- Having a family member with psychosis
- Current or lifetime major DSM-IV Axis I disorder
- Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
- Major or unstable medical illness that might impact safety of the subject in the study
- Cannabis naive
- IQ less than 85
- Less than a high school diploma or its educational equivalent
- Pregnancy or lactation
- Major current or recent (<6 weeks) psychosocial stressors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: No Family History of Psychosis (FHN)
Individuals recruited with no history of psychosis in the family.
They will receive the placebo, very low dose THC, and low dose THC interventions.
|
placebo
Subjects will receive 0.010mg/kg.
Other Names:
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Names:
|
Experimental: Family History of Psychosis (FHP)
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.
|
placebo
Subjects will receive 0.010mg/kg.
Other Names:
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: -30 min from administration of THC
|
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
|
-30 min from administration of THC
|
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: +80 min from administration of THC
|
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
|
+80 min from administration of THC
|
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: +150 min of administration of THC
|
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
|
+150 min of administration of THC
|
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time Frame: +240 min of administration of THC
|
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
|
+240 min of administration of THC
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician Administered Dissociative Symptoms Scale (CADSS)
Time Frame: -30 min, +15 min, +80 min, +150 min, +240 min
|
Perceptual alterations will be measured using the CADSS.
This is a scale consisting of 19 self-report items and 8 clinician-rated items (0=not at all, 4=extremely).
The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.
|
-30 min, +15 min, +80 min, +150 min, +240 min
|
Visual Analog Scale (VAS)
Time Frame: -30 min, +15 min, +80 min, +150 min, +240 min
|
Feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states ("high", "anxious", "calm and relaxed", and "tired") associated with cannabis effects.
Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11 mm line (0=not at all, 100=extremely).
These data will be captured to validate that the experiment is relevant to cannabis effects.
|
-30 min, +15 min, +80 min, +150 min, +240 min
|
Hopkins Verbal Learning Test (HVLT)
Time Frame: +50 min
|
The HVLT is a 12 word list that is semantically organized.
The task consists of 5 trials, an interference list, and free delayed recall and recognition.
A different version of the AVLT will be administered on each test day and counterbalanced across subjects.
|
+50 min
|
Psychotomimetic States Inventory (PSI)
Time Frame: -30 min, +240 min
|
The PSI is a measure of drug induced psychotomimetic states.
This self-report scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.
|
-30 min, +240 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohini Ranganathan, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 26, 2014
First Submitted That Met QC Criteria
March 28, 2014
First Posted (Estimated)
April 2, 2014
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Mental Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- 1310012948
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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