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

Early Phase 1

Active, not recruiting

• Conditions: Schizophrenia; Marijuana; Psychosis; Cannabis Use; THC
• Interventions: Drug: Placebo; Drug: Very Low Dose THC; Drug: Low Dose THC

• Registration Number: NCT02102113
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Family History of Psychosis (FHP)	Very Low Dose THC	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.
No Family History of Psychosis (FHN)	Very Low Dose THC	Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.
No Family History of Psychosis (FHN)	Low Dose THC	Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.
No Family History of Psychosis (FHN)	Placebo	Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.
Family History of Psychosis (FHP)	Placebo	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.
Family History of Psychosis (FHP)	Low Dose THC	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.

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptom Scale for Schizophrenia (PANSS)	+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.

Secondary Outcome Measures

Name	Time	Method
Hopkins Verbal Learning Test (HVLT)	+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.
Clinician Administered Dissociative Symptoms Scale (CADSS)	-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.
Visual Analog Scale (VAS)	-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.
Psychotomimetic States Inventory (PSI)	-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.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States