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Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01382433
Recruitment Status : Unknown
Verified December 2011 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : June 27, 2011
Last Update Posted : January 2, 2012
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:

The aim of the current study is set out to find a human model for negative symptoms based on clinical observation that chronic cannabis users express negative symptoms and characterize by the same neurocognitive and electrophysiology characteristics like patient suffer from schizophrenia. Towards that end the first part of the study is set out to explore weather chronic cannabis user's express negative symptoms similar to patient suffer from schizophrenia. The second part of the study will explore the neurocognitive and electrophysiology characteristics of those cannabis users that express negative symptoms. This data will be compared to parallel data of schizophrenia patients with predominantly negative symptom.

Several lines of biological and genetic evidence support the cannabinoid hypothesis for schizophrenia. Particularly, it is most significant clinically that the possible involvement of the cannabinoid system in the neural basis for the negative symptoms. This hypothesis based on clinical findings that chronic cannabis use causes a combination of symptoms including apathy, avolition, lack of interest, passivity, and cognitive impairments, the so-called "amotivational syndrome," which resembles the core negative symptoms of schizophrenia in behavioral level as well as the brain level. Both are associated with the functions or integrity of the frontal lobe due to its role in creating self-directed behaviors, deficits in which may underlie alogia, anhedonia, and flat affect. Despite the aforementioned similarities, to date, there is no documentation for such a relationship. Recognition that chronic cannabis users share the same or similar constellation of symptoms and similar neurocognitive and electrophysiology characteristics could provide a key to develop a human model for negative symptoms and an essential tool to comprehensive understanding of the etiology of negative symptoms and development of an innovative therapy.

The investigators Hypothesize That Chronic Cannabis Users Would Express the Same Constellation of Behaviors as Negative Symptoms of Schizophrenia; as well as similar neurocognitive and electrophysiology characteristics


Condition or disease Intervention/treatment Phase
Chronic Cannabis Users Healthy Subjects Procedure: Magnetoencephalograph (MEG) Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB). Behavioral: Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Assessment of Negative Symptoms Neurocognitive and Electrophysiological Characteristics in Chronic Cannabis Users
Study Start Date : July 2011
Estimated Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chronic Cannabis Users Procedure: Magnetoencephalograph (MEG)
Brain imaging device that records the magnetic fields in the brain.

Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB).
the CANTAB is sensitive to cognitive changes caused by a wide range of Central Nervous System disorders and medication side-effects . The CANTAB uses a computer with a touch screen, and affords a rapid and non-invasive assessment of cognitive functions.

Behavioral: Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)
The SANS and PANSS scales asses the presence and severity of Positive and Negative of Schizophrenia

Experimental: Control
Neurotypical subjects
Procedure: Magnetoencephalograph (MEG)
Brain imaging device that records the magnetic fields in the brain.

Behavioral: Cambridge Neuropsychological Test Automated Battery (CANTAB).
the CANTAB is sensitive to cognitive changes caused by a wide range of Central Nervous System disorders and medication side-effects . The CANTAB uses a computer with a touch screen, and affords a rapid and non-invasive assessment of cognitive functions.

Behavioral: Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)
The SANS and PANSS scales asses the presence and severity of Positive and Negative of Schizophrenia




Primary Outcome Measures :
  1. Clinical Measure [ Time Frame: 30 min ]
    All participants will be assessed for negative symptoms using the Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)

  2. Cognitive Measure [ Time Frame: 1 hour ]
    Cognitive Measure - All participants will be assessed for Cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB).

  3. Electrophysiological Measure [ Time Frame: 1 hour ]
    Electrophysiological Measure- - All participants will be assessed for Electrophysiological assesment using the MEG (Magnetoencephalogram)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for both groups:

  1. Healthy men and women
  2. Ages 20-65
  3. Give informed consent for participation in the study.

Inclusion Criteria for the control:

-Used cannabis maximum 50 times in their lives, and no more than once during the past year.

Inclusion Criteria for the experimental:

-Use of cannabis for at least 2 years and in the last 6 months for at least 4 days a week.

(-After minimum 12 hours of abstinence (in order to eliminate acute cannabis effects, minimize the withdrawal effect while retaining neurophysiological effects from altered CB1 activity).

Exclusion Criteria for both groups:

(To prevent MEG artifacts by non relevant electric interference or brain conditions)

  • History of epilepsy, seizure, or hot spasm, sever head injuries.
  • History of metal in the head (outside the mouth space).
  • History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
  • History of migraines.
  • History of drug or alcohol abuse during the last year. Inability to achieve satisfying level of communication with the subject Control Group (healthy Subjects)
  • History of psychiatric diagnosis
  • Drug or alcohol addiction in the year prior to the study
  • History of epilepsy, seizure, or hot spasm.
  • History of head injuries.
  • History of metal in the head (outside the mouth space).
  • History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
  • History of migraines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382433


Contacts
Contact: keren yefet 052-8812960

Locations
Israel
Bar-Ilan University Recruiting
Givat Shmuel, Israel
Contact: keren yefet, PHD    052-8812960      
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Hilik Levkovitz, prof. shalvata MHC

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01382433     History of Changes
Other Study ID Numbers: 0010-11-SHA
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011

Keywords provided by Shalvata Mental Health Center:
Chronic Cannabis Users
negative symptoms
cognitive electrophysiology functions

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders