- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01565174
The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis
April 1, 2012 updated by: VEINSHTEIN AVIV, Hadassah Medical Organization
There is growing evidence of high rates of substance use disorders among individuals with psychotic disorders especially in young people with predisposition for psychosis.
There is some genetic evidence that carriers of the valine158 allele of the catechol-O-methyltransferase (COMT) gene had increased risk to exhibit psychotic symptoms and to develop schizophrenia if they used cannabis by the age of 18.
It was also shown that carriers of the COMT val/val genotype were most sensitive to THC-induced psychotic experiences but this was conditional on pre-existing susceptibility to psychosis.
The investigators propose to use brain-imaging and molecular genetics to investigate whether genetic factors may contribute to the THC-induced dopamine release and possibly to cannabis- induced psychosis.
Study Overview
Status
Unknown
Conditions
Detailed Description
Genetic association study will be performed in 100 young cannabis users (age 18-26 years) for genes that are related to the neurotransmitters dopamine (D2, DAT, COMT), GABA, glutamate and the cannabinoid receptor CB1.
Out of this cohort, 24 male subjects without history of cannabis or drug-induced psychosis will undergo brain imaging procedure in order to measure THC-induced dopamine release using [11C] Raclopride in PET imaging.
Carriers of high activity COMT158Val allele are expected to show higher meso-limbic DA release than carriers of low activity COMT 158Met homozygotes and after smoking a cigarette with THC which in turn are thought to underlie the risk for THC-induced psychotic symptoms.
The aim of the present study is to evaluate the relationship between the COMT genotype and cannabis-induced meso-limbic dopamine release as measured by D2 occupancy.
In addition, the association between predisposition to psychosis, age of onset of cannabis dependence, and genotype of COMT and other neurotransmitters-related genes will be evaluated.
Such finding could provide novel pharmaco-genetic explanation for the psychogenic effects of cannabis in vulnerable individuals.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aviv M Weinstein, Ph.D
- Phone Number: 972-2-6776705
- Email: avivweinstein@yahoo.com
Study Contact Backup
- Name: Roland Chisin, M.D
- Phone Number: 972-2-6776705
- Email: chisin@hadassah.org.il
Study Locations
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Jerusalem, Israel, 91120
- Hadassah Medical Organization, Jerusalem, Israel
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Principal Investigator:
- Aviv M Weinstein, Ph.D
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Contact:
- Hadas Lemberg, Ph.D
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 26 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
100 current users of cannabis
Description
Inclusion Criteria:
- age 18-26 meeting DSM-IV-TR (American Psychiatric Association, 1994) diagnosis of THC dependence will be recruited from the general population by advertisement in the newspapers.
Exclusion Criteria:
- dependence on other substances or alcoholism
- a history of CNS disease
- a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes)
- a history of head injury with loss of consciousness and pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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High activity COMT
Carriers of high activity COMT158Val allele who are expected to show higher THC-induced meso-limbic DA release
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Low activity COMT
Carriers of low activity COMT 158Met homozygotes are expected to release low amount of dopamine after smoking a cigarette with THC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic variations of Dopamine, GABA, glutamate, cannabis CB1 receptor
Time Frame: 2 years
|
DNA will be extracted from saliva of participants.
Genetic variations of DA, GABA, glutamate and cannabis receptor CB1 will be coded.
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures of dopamine D2 receptor occupancy before and after smoking a cigarette containing THC.
Time Frame: 2 years
|
Participants will be studied in a brain imaging study using [C 11] raclopride radioligand in Positron Emission Tomography (PET).
Measures of D2 receptor occupancy will be taken at baseline and after smoking a cigarette containing 15 mg THC.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aviv Weinstein, Ph.D, Hadassah Medical Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
March 27, 2012
First Posted (Estimate)
March 28, 2012
Study Record Updates
Last Update Posted (Estimate)
April 3, 2012
Last Update Submitted That Met QC Criteria
April 1, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0541-11-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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