NCT00085865

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 \[11C\]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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 4, 2008

Status Verified

July 1, 2006

First QC Date

June 15, 2004

Last Update Submit

March 3, 2008

Conditions

Keywords

5 HTNeuroreceptorsRadiotracerNeuroimagingSerotonin TransporterAlcoholismPETHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75
  • DSM-IV criteria for alcohol dependence or alcohol abuse.
  • Age: 18-75

You may not qualify if:

  • 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.
  • Serious organic disease e.g. liver disease.
  • Claustrophobia.
  • Pregnancy.
  • Prior participation in other research protocols within the past 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Fujita M, Charney DS, Innis RB. Imaging serotonergic neurotransmission in depression: hippocampal pathophysiology may mirror global brain alterations. Biol Psychiatry. 2000 Oct 15;48(8):801-12. doi: 10.1016/s0006-3223(00)00960-4.

    PMID: 11063976BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 15, 2004

First Posted

June 16, 2004

Study Start

June 1, 2004

Study Completion

July 1, 2006

Last Updated

March 4, 2008

Record last verified: 2006-07

Locations