Clinical trial NCT02102113: Probing the Cannabinoid System in Individuals With a Family History of Psychosis
Official title: Probing the Cannabinoid System in Individuals With a Family History of Psychosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Psychosis
Cannabis Use
THC
Marijuana
Schizophrenia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: -30 min from administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: +80 min from administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: +150 min of administration of THC
measure: Positive and Negative Symptom Scale for Schizophrenia (PANSS)
timeFrame: +240 min of administration of THC
Secondary outcomes:
measure: Clinician Administered Dissociative Symptoms Scale (CADSS)
timeFrame: -30 min, +15 min, +80 min, +150 min, +240 min
measure: Visual Analog Scale (VAS)
timeFrame: -30 min, +15 min, +80 min, +150 min, +240 min
measure: Hopkins Verbal Learning Test (HVLT)
timeFrame: +50 min
measure: Psychotomimetic States Inventory (PSI)
timeFrame: -30 min, +240 min
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Mohini Ranganathan, MD
role: PRINCIPAL_INVESTIGATOR
References: