Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia
NCT ID: NCT01382433
Last Updated: 2012-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
115 participants
INTERVENTIONAL
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cannabis and Schizophrenia: Self-Medication and Agonist Treatment
NCT00946348
The Effects of Cannabis Use in People With Schizophrenia on Clinical, Neuropsychological and Physiological Phenotypes
NCT01832766
Imaging Cannabinoid CB1 Receptors in Schizophrenia
NCT01063335
Adapted Cognitive/Affective Remediation for Cannabis Misuse in Schizophrenia
NCT01292577
Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia
NCT00588731
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chronic Cannabis Users
Magnetoencephalograph (MEG)
Brain imaging device that records the magnetic fields in the brain.
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.
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
Control
Neurotypical subjects
Magnetoencephalograph (MEG)
Brain imaging device that records the magnetic fields in the brain.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnetoencephalograph (MEG)
Brain imaging device that records the magnetic fields in the brain.
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.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ages 20-65
3. Give informed consent for participation in the study.
-Used cannabis maximum 50 times in their lives, and no more than once during the past year.
-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
* 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.
20 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shalvata Mental Health Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hilik Levkovitz, prof.
Role: PRINCIPAL_INVESTIGATOR
shalvata MHC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bar-Ilan University
Givat Shmuel, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
keren yefet
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
keren yefet, PHD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0010-11-SHA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.