Trial record 2 of 81 for:    Open Studies | "family history"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02102113
First received: March 26, 2014
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Psychosis
Schizotypy
Cannabis Use
Drug: Placebo
Drug: Very Low Dose THC
Drug: Low Dose THC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Probing the Cannabinoid System in Individuals With a Family History of Psychosis

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Positive and Negative Symptom Scale for Schizophrenia (PANSS) [ Time Frame: -30 min from administration of THC ] [ Designated as safety issue: No ]
    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) [ Time Frame: +80 min from administration of THC ] [ Designated as safety issue: No ]
    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) [ Time Frame: +150 min of administration of THC ] [ Designated as safety issue: No ]
    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) [ Time Frame: +240 min of administration of THC ] [ Designated as safety issue: No ]
    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) [ Time Frame: -30 min, +15 min, +80 min, +150 min, +240 min ] [ Designated as safety issue: No ]
    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) [ Time Frame: -30 min, +15 min, +80 min, +150 min, +240 min ] [ Designated as safety issue: No ]
    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) [ Time Frame: +50 min ] [ Designated as safety issue: No ]
    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) [ Time Frame: -30 min, +240 min ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 72
Study Start Date: January 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: delta 9-tetrahydrocannabinol
Drug: Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Name: 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 Name: delta 9-tetrahydrocannabinol
Drug: Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Name: delta 9-tetrahydrocannabinol

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102113

Contacts
Contact: Prerana Purohit 203-932-5711 ext 4495 prerana.purohit@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Prerana Purihot    203-932-5711 ext 4495    prerana.purohit@yale.edu   
Principal Investigator: Mohini Ranganathan         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mohini Ranganathan MYSM School Of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02102113     History of Changes
Other Study ID Numbers: HIC1310012948
Study First Received: March 26, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014