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

NCT02102113 | Active Not Recruiting Early Phase 1

• 1 other identifier: 1310012948
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Cannabis Use; THC; Marijuana; Schizophrenia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Clinician Administered Dissociative Symptoms Scale (CADSS)

  -30 min, +15 min, +80 min, +150 min, +240 min

• Visual Analog Scale (VAS)

  -30 min, +15 min, +80 min, +150 min, +240 min

• Hopkins Verbal Learning Test (HVLT)

  +50 min

• Psychotomimetic States Inventory (PSI)

  -30 min, +240 min

Study Arms (2)

No Family History of Psychosis (FHN)

OTHER

Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.

Drug: Placebo; Drug: Very Low Dose THC; Drug: Low Dose THC

Family History of Psychosis (FHP)

EXPERIMENTAL

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.

Drug: Placebo; Drug: Very Low Dose THC; Drug: Low Dose THC

Interventions

Placebo DRUG

placebo

Family History of Psychosis (FHP); No Family History of Psychosis (FHN)

Very Low Dose THC DRUG

Subjects will receive 0.010mg/kg.

Also known as: delta 9-tetrahydrocannabinol

Family History of Psychosis (FHP); No Family History of Psychosis (FHN)

Low Dose THC DRUG

Subjects will receive 0.018 mg/kg over 20 minutes.

Also known as: delta 9-tetrahydrocannabinol

Family History of Psychosis (FHP); No Family History of Psychosis (FHN)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Exposure to cannabis at least once in their lifetime
• Medically and psychiatrically healthy based on screening
• Having one relative with a confirmed psychotic disorder

You may not qualify if:

• 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.
• Exposure to cannabis at least once in their lifetime
• Medically and psychiatrically healthy based on screening
• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Marijuana Abuse; Schizophrenia

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Mohini Ranganathan, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 2, 2014
• Study Start: January 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2024-08

Locations

US (1)