Chronic Cannabis UsersNCT01382433
Chronic Cannabis Users: A Model for Negative Symptoms in Schizophrenia
A study testing Magnetoencephalograph (MEG), Cambridge Neuropsychological Test Automated Battery (CANTAB). and Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS) in people with Chronic Cannabis Users and Healthy Subjects, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cannabis Users, Healthy Subjects
- What is being tested?
- Magnetoencephalograph (MEG), Cambridge Neuropsychological Test Automated Battery (CANTAB). and Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women
- Ages 20-65
- 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).
Who cannot join
- (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)
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- 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.
Trial locations and contacts
1 site in 1 country.
keren yefet contact
Israel1 site, 1 recruiting
- Recruiting
Bar-Ilan University
Givat Shmuel
keren yefet, PHD, 052-8812960
About this study
Official title: Clinical Assessment of Negative Symptoms Neurocognitive and Electrophysiological Characteristics in Chronic Cannabis Users
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
- Conditions
- Chronic Cannabis Users, Healthy Subjects
- Being tested
- 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)
- Keywords
- Chronic Cannabis Users, negative symptoms, cognitive electrophysiology functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetoencephalograph (MEG)Procedure or surgery
Brain imaging device that records the magnetic fields in the brain.
Cambridge Neuropsychological Test Automated Battery (CANTAB).Behavioural
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)Behavioural
The SANS and PANSS scales asses the presence and severity of Positive and Negative of Schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Chronic Cannabis Users | Experimental | Not described Receives: 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) |
| Control | Experimental | Neurotypical subjects Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 min
Cognitive Measure
Cognitive Measure - All participants will be assessed for Cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Measured: 1 hour
Electrophysiological Measure
Electrophysiological Measure- - All participants will be assessed for Electrophysiological assesment using the MEG (Magnetoencephalogram)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cannabis UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilik Levkovitz, prof., Principal investigator, shalvata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382433
- Sponsor's protocol ID
- 0010-11-SHA
- Status last verified
- Dec 2011
- First submitted
- 23 Jun 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Negative Symptoms Neurocognitive and Electrophysiological Characteristics in Chronic Cannabis Users
- ClinicalTrials.gov ID
- NCT01382433
- Acronym / sponsor ID
- 0010-11-SHA
- Conditions
- Chronic Cannabis Users, Healthy Subjects
- Keywords
- Chronic Cannabis Users, negative symptoms, cognitive electrophysiology functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Cannabis Users | Experimental | 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) |
| Control | Experimental | 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)Neurotypical subjects |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy men and women
- Ages 20-65
- 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.
Key exclusion criteria (13 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetoencephalograph (MEG)Brain imaging device that records the magnetic fields in the brain. | Procedure or surgery | Chronic Cannabis Users, Control |
| 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. | Behavioural | Chronic Cannabis Users, Control |
| 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 | Behavioural | Chronic Cannabis Users, Control |
Primary outcome
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)
Cognitive Measure
Time frame: 1 hour
Cognitive Measure - All participants will be assessed for Cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Electrophysiological Measure
Time frame: 1 hour
Electrophysiological Measure- - All participants will be assessed for Electrophysiological assesment using the MEG (Magnetoencephalogram)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
keren yefet contact
Hilik Levkovitz, prof. principal investigator
shalvata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetoencephalograph (MEG), Cambridge Neuropsychological Test Automated Battery (CANTAB). and Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS) in people with Chronic Cannabis Users and Healthy Subjects, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact keren yefet (052-8812960), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Measure (time frame: 30 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.