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

  • United States
    • 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.
Drug: Placebo
placebo
Drug: Very Low Dose THC
Subjects will receive 0.010mg/kg.
Other Names:
  • delta 9-tetrahydrocannabinol
Drug: Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Names:
  • delta 9-tetrahydrocannabinol
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.
Drug: Placebo
placebo
Drug: Very Low Dose THC
Subjects will receive 0.010mg/kg.
Other Names:
  • delta 9-tetrahydrocannabinol
Drug: Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Names:
  • delta 9-tetrahydrocannabinol

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

Yale University

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

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.

Clinical Trials on Schizophrenia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe