search
Back to results

Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia

Primary Purpose

Chronic Cannabis Users, Healthy Subjects

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Magnetoencephalograph (MEG)
Cambridge Neuropsychological Test Automated Battery (CANTAB).
Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Cannabis Users focused on measuring Chronic Cannabis Users, negative symptoms, cognitive electrophysiology functions

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bar-Ilan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chronic Cannabis Users

Control

Arm Description

Neurotypical subjects

Outcomes

Primary Outcome Measures

Clinical Measure
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)
Cognitive Measure
Cognitive Measure - All participants will be assessed for Cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Electrophysiological Measure
Electrophysiological Measure- - All participants will be assessed for Electrophysiological assesment using the MEG (Magnetoencephalogram)

Secondary Outcome Measures

Full Information

First Posted
June 23, 2011
Last Updated
December 29, 2011
Sponsor
Shalvata Mental Health Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01382433
Brief Title
Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia
Official Title
Clinical Assessment of Negative Symptoms Neurocognitive and Electrophysiological Characteristics in Chronic Cannabis Users
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cannabis Users, Healthy Subjects
Keywords
Chronic Cannabis Users, negative symptoms, cognitive electrophysiology functions

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic Cannabis Users
Arm Type
Experimental
Arm Title
Control
Arm Type
Experimental
Arm Description
Neurotypical subjects
Intervention Type
Procedure
Intervention Name(s)
Magnetoencephalograph (MEG)
Intervention Description
Brain imaging device that records the magnetic fields in the brain.
Intervention Type
Behavioral
Intervention Name(s)
Cambridge Neuropsychological Test Automated Battery (CANTAB).
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)
Intervention Description
The SANS and PANSS scales asses the presence and severity of Positive and Negative of Schizophrenia
Primary Outcome Measure Information:
Title
Clinical Measure
Description
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)
Time Frame
30 min
Title
Cognitive Measure
Description
Cognitive Measure - All participants will be assessed for Cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Time Frame
1 hour
Title
Electrophysiological Measure
Description
Electrophysiological Measure- - All participants will be assessed for Electrophysiological assesment using the MEG (Magnetoencephalogram)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for both groups: Healthy men and women Ages 20-65 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
keren yefet
Phone
052-8812960
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilik Levkovitz, prof.
Organizational Affiliation
shalvata MHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bar-Ilan University
City
Givat Shmuel
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
keren yefet, PHD
Phone
052-8812960

12. IPD Sharing Statement

Learn more about this trial

Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia

We'll reach out to this number within 24 hrs