NCT01035723

Brief Summary

Background: \- New research on genetics and the human genome has helped to identify certain genes that affect specific parts of the brain, including the parts that may be involved in drug use and dependency. Researchers are interested in studying both genetic information and brain activity to better understand variations in brain function among individuals. Objectives: \- To study brain activity in conjunction with specific genetic information provided by healthy volunteers including smokers, non-smokers, people with drug dependence, and those who do not have any dependence on any substance. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design:

  • This is an 8 10 hour study which may be completed in 1, 2, or 3 visits.
  • Participants will complete questionnaires about emotional and psychological responses to different situations, including stressful situations.
  • Participants will have a training session in a mock (fake) scanner to practice tasks to be completed in the real scanner.
  • Participants will have the following two types of magnetic resonance imaging (MRI) scans in one scan session of the brain:
  • A structural MRI scan to provide basic information about each participant's brain.
  • A functional MRI scanning session, in which participants will perform a memory task to provide information about brain activity.
  • Participants will provide blood samples for research and testing....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 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

September 13, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2013

Completed
Last Updated

December 16, 2019

Status Verified

February 25, 2013

First QC Date

December 18, 2009

Last Update Submit

December 13, 2019

Conditions

Drug Abuse

Keywords

Prefrontal CortexHippocampusAmygdalaMRICognitive Tasks

Outcome Measures

Primary Outcomes (1)

  • To understand the relationship between genetic polymorphisms and brain morphology and their association to brain function and behavior.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To be eligible for this study, subjects must:
  • Be between the ages of 18 and 50.
  • Be in good health.
  • Be right handed.
  • Individuals with a substance abuse disorder may be included.

You may not qualify if:

  • Subjects will be excluded if they:
  • Are not suitable to undergo an MRI experiment due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts), body morphology, or claustrophobia.
  • Have coagulopathies, history of or current superficial or deep vein thrombosis, musculoskeletal abnormalities restricting an individual s ability to lie flat for an extended period of time.
  • Have HIV or syphilis.
  • Have a neurological illness to include, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
  • Have any current AXIS I psychiatric disorders including Attention Deficit Disorder (ADD). Have regular use of any prescription, over-the-counter, or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling.
  • Have current dependence on any substance other than cocaine, marijuana, or nicotine.
  • Are cognitively impaired or are learning disabled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Austin CP, Ma L, Ky B, Morris JA, Shughrue PJ. DISC1 (Disrupted in Schizophrenia-1) is expressed in limbic regions of the primate brain. Neuroreport. 2003 May 23;14(7):951-4. doi: 10.1097/01.wnr.0000074342.81633.63.

    PMID: 12802181BACKGROUND

  • Bartzokis G, Altshuler LL, Greider T, Curran J, Keen B, Dixon WJ. Reliability of medial temporal lobe volume measurements using reformatted 3D images. Psychiatry Res. 1998 Apr 10;82(1):11-24. doi: 10.1016/s0925-4927(98)00007-9.

    PMID: 9645547BACKGROUND

  • Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

    PMID: 12615092BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Elliot Stein, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 21, 2009

Study Start

September 13, 2005

Study Completion

February 25, 2013

Last Updated

December 16, 2019

Record last verified: 2013-02-25

Locations

US(1)