Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085865
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-06-15
Brief Title:
Serotonin Transporters in Alcoholism
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Evaluation of Serotonin Transporters Using C-11 DASB in Alcoholism
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare serotonin transporter proteins in people with alcoholism and healthy volunteers to examine how these proteins may be related to the inability of people with alcoholism to appropriately regulate their alcohol consumption Serotonin transporters regulate levels of the brain chemical serotonin Problems in this regulation have been implicated in alcoholism
Healthy normal volunteers and people who suffer from alcoholism who are between 18 and 75 years of age may be eligible for this study Candidates are screened with a medical history and physical examination psychiatric diagnostic interview blood and urine tests an electrocardiogram urine toxicology screen and written psychological evaluations
Participants undergo positron emission tomography PET and magnetic resonance imaging MRI scanning to measure serotonin transporter levels in the brain
PET uses small amounts of a radioactive chemical called a tracer that labels the serotonin transporters in the brain The tracer used in this study is 11CDASB For the procedure the subject lies on the scanner bed A special mask is fitted to the head and attached to the bed to help keep the subjects head still during the scan so the images will be clear A brief scan is done just before the radioactive tracer is injected This scan provides measures of the brain that will help in the precise calculation of information from subsequent scans After the tracer is injected through a catheter plastic tube placed in the arm pictures are taken for about 2 hours
MRI uses a magnetic field and radio waves to produce pictures of brain structure The subject lies on a bed that slides into the tube-like scanner wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched The scan takes about an hour during which time the subject can communicate with the technician
Healthy normal volunteers and people who suffer from alcoholism who are between 18 and 75 years of age may be eligible for this study Candidates are screened with a medical history and physical examination psychiatric diagnostic interview blood and urine tests an electrocardiogram urine toxicology screen and written psychological evaluations
Participants undergo positron emission tomography PET and magnetic resonance imaging MRI scanning to measure serotonin transporter levels in the brain
PET uses small amounts of a radioactive chemical called a tracer that labels the serotonin transporters in the brain The tracer used in this study is 11CDASB For the procedure the subject lies on the scanner bed A special mask is fitted to the head and attached to the bed to help keep the subjects head still during the scan so the images will be clear A brief scan is done just before the radioactive tracer is injected This scan provides measures of the brain that will help in the precise calculation of information from subsequent scans After the tracer is injected through a catheter plastic tube placed in the arm pictures are taken for about 2 hours
MRI uses a magnetic field and radio waves to produce pictures of brain structure The subject lies on a bed that slides into the tube-like scanner wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched The scan takes about an hour during which time the subject can communicate with the technician
Detailed Description:
Alcoholism is characterized by the inability of individuals to regulate their consumption of alcohol appropriately Serotonergic dysfunction has been implicated in the pathophysiology of this illness Serotonin transporters SERT critically regulate the tone of serotonergic transmission Gobbi et al 2001 In a brain imaging study using the SPECT radioligand 123I Beta-CIT male alcoholics who had abstained from alcohol for more than four weeks had significantly reduced serotonin transporters in the raphe area of the brainstem compared to healthy control subjects Heinz et al 1998 However the 123I Beta-CIT ligand binds with high affinity to both the dopamine transporter DAT and SERT Binding of 123I Beta-CIT in regions rich in SERT or DAT have been attributed to SERT and DAT respectively but in regions of mixed innervation eg cortical regions it is not possible to distinguish between SERT and DAT
11CDASB is a PET ligand with high affinity for SERT with almost 1000 fold selectivity versus DAT Using this tracer we will be able to measure SERT binding in cortical and subcortical brain regions including those with mixed innervation 11C DASB PET studies in humans Houle et al 2000 Meyer et al 2001 indicate the feasibility of quantifying SERT binding in SERT rich regions In the current protocol we plan to use PET imaging with the radioligand 11C DASB for serotonin transporter SERT to delineate regional abnormalities in SERT binding in two subject groups consisting of 30 patients with alcoholism and 30 healthy volunteers Our goal of the present study is to further our understanding of the roles of the serotonergic systems in the pathophysiology of alcoholism
11CDASB is a PET ligand with high affinity for SERT with almost 1000 fold selectivity versus DAT Using this tracer we will be able to measure SERT binding in cortical and subcortical brain regions including those with mixed innervation 11C DASB PET studies in humans Houle et al 2000 Meyer et al 2001 indicate the feasibility of quantifying SERT binding in SERT rich regions In the current protocol we plan to use PET imaging with the radioligand 11C DASB for serotonin transporter SERT to delineate regional abnormalities in SERT binding in two subject groups consisting of 30 patients with alcoholism and 30 healthy volunteers Our goal of the present study is to further our understanding of the roles of the serotonergic systems in the pathophysiology of alcoholism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-M-0208 | None | None | None |