NIH Clinical Research Studies

Protocol Number: 04-M-0208

Active Accrual, Protocols Recruiting New Patients

Title:
PET Evaluation of Serotonin Transporters Using [C-11] DASB in Alcoholism
Number:
04-M-0208
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 [11C]DASB. 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 subject's 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.

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
ELIGIBILITY CRITERIA:

Alcoholic and healthy subjects will be recruited from those screened by Dr. Daniel Hommer's protocol (protocol number 98-AA-0009) which is used to identify and recruit adult participants who meet DSM-IV criteria for alcohol dependence or alcohol abuse and healthy controls.

Subjects will be recruited primarily from the Washington, DC metropolitan area through newspaper advertisements. Subjects will also be recruited through outreach to health care professionals and treatment facilities throughout Northern Virginia, West Virginia and the Washington, DC and Baltimore metropolitan areas. Patient referrals throughout the U.S. and on occasion international referrals also will be used.

We have decided to exclude children from this protocol.

Age 18-75.

INCLUSION CRITERIA - PATIENTS:

DSM-IV criteria for alcohol dependence or alcohol abuse.

EXCLUSION CRITERIA - PATIENTS AND CONTROLS:

Other current DSM-IV Axis I diagnostic criteria than alcohol dependence or alcohol abuse.

Psychotropic medication or other drugs that may cross the blood brain barrier.

Drug free period must be greater than 4 weeks (antidepressants) and greater than 6 weeks (fluoxetine, antipsychotics, anticonvulsants).

Serious organic disease e.g. liver disease.

Claustrophobia.

Pregnancy.

Prior participation in other research protocols within the pats year such that a radiation exposure together with the present study would exceed the annual limits.

Any condition that increases risk for MRI (e.g., pacemaker, metallic foreign body in the eye, etc.)

Special Instructions: Currently Not Provided
Keywords:
5 HT
Neuroreceptors
Radiotracer
Neuroimaging
Serotonin Transporter
Alcoholism
PET
Recruitment Keywords:
Alcoholism
Healthy Volunteer
HV
Conditions:
Alcoholism
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23. PMID: 9374364

Fils-Aime ML, et al. Early-onset alcoholics have lower cerebrospinal fluid 5-hydroxyindoleacetic acid levels than late-onset alcoholics. Arch Gen Psychiatry. 1996 Mar;53(3):211-6. PMID: 8611057

Fujita M, et al. Imaging serotonergic neurotransmission in depression: hippocampal pathophysiology may mirror global brain alterations. Biol Psychiatry. 2000 Oct 15;48(8):801-12. PMID: 11063976

Active Accrual, Protocols Recruiting New Patients

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