search
Back to results

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

Primary Purpose

Psychosis, Cannabis Use, THC

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Very Low Dose THC
Low Dose THC
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No Family History of Psychosis (FHN)

Family History of Psychosis (FHP)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 26, 2014
Last Updated
August 4, 2023
Sponsor
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT02102113
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Cannabis Use, THC, Marijuana, Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Family History of Psychosis (FHN)
Arm Type
Other
Arm Description
Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.
Arm Title
Family History of Psychosis (FHP)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
Very Low Dose THC
Other Intervention Name(s)
delta 9-tetrahydrocannabinol
Intervention Description
Subjects will receive 0.010mg/kg.
Intervention Type
Drug
Intervention Name(s)
Low Dose THC
Other Intervention Name(s)
delta 9-tetrahydrocannabinol
Intervention Description
Subjects will receive 0.018 mg/kg over 20 minutes.
Primary Outcome Measure Information:
Title
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Description
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Time Frame
-30 min from administration of THC
Title
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Description
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Time Frame
+80 min from administration of THC
Title
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Description
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Time Frame
+150 min of administration of THC
Title
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Description
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Time Frame
+240 min of administration of THC
Secondary Outcome Measure Information:
Title
Clinician Administered Dissociative Symptoms Scale (CADSS)
Description
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.
Time Frame
-30 min, +15 min, +80 min, +150 min, +240 min
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
-30 min, +15 min, +80 min, +150 min, +240 min
Title
Hopkins Verbal Learning Test (HVLT)
Description
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.
Time Frame
+50 min
Title
Psychotomimetic States Inventory (PSI)
Description
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.
Time Frame
-30 min, +240 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohini Ranganathan, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs