Probing the Cannabinoid System in Individuals With a Family History of Psychosis

Schizophrenia Clinical Trial

Official title:

Probing the Cannabinoid System in Individuals With a Family History of Psychosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02102113
• Other study ID #: 1310012948
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 2014
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use
• Marijuana
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia
• THC

Intervention

Drug:
• Placebo
placebo
• Very Low Dose THC
Subjects will receive 0.010mg/kg.
• Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Symptom Scale for Schizophrenia (PANSS)	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
Primary	Positive and Negative Symptom Scale for Schizophrenia (PANSS)	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
Primary	Positive and Negative Symptom Scale for Schizophrenia (PANSS)	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
Primary	Positive and Negative Symptom Scale for Schizophrenia (PANSS)	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	Clinician Administered Dissociative Symptoms Scale (CADSS)	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
Secondary	Visual Analog Scale (VAS)	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
Secondary	Hopkins Verbal Learning Test (HVLT)	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
Secondary	Psychotomimetic States Inventory (PSI)	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