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Characterization of Phenotypic and Genotypic Regressors for Imaging

This study is currently recruiting participants.
Verified July 26, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148381
First Posted: June 22, 2010
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
  Purpose

The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users.

Objectives:

- To collect genetic information for research on genetic aspects of addiction and substance abuse.

Eligibility:

  • Adolescents and adults between 13 and 55 years of age who are (1) healthy, non-drug-using nonsmokers, (2) healthy smokers, (3) healthy individuals dependent on other commonly abused drugs, and (4) individuals with other psychiatric disorders.
  • Participants must be right-handed, and must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol.

Design:

  • This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant s current research protocol study visits or on the same day as those visits. .
  • Participants will provide a blood sample and complete questionnaires about mood, memory, and learning.
  • Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.

Condition
Regressors

Study Type: Observational
Study Design: Time Perspective: Other
Official Title: Characterization of Phenotypic and Genotypic Regressors for MRI

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):

Estimated Enrollment: 2625
Study Start Date: June 4, 2010
Detailed Description:

Objective: To determine genetic variants as well as behavioral measures across different study group populations. Results of these will be used as regressors to help explain inter-individual differences in data collected across IRP protocols.

Study Population: The study population will include 1) healthy non-smoking, non-drug dependent participants 2) healthy nicotine-dependent individuals 3) healthy individuals dependent on other commonly abused drugs 4) individuals with other psychiatric disorders and 5) treatment-seeking individuals dependent on nicotine or other commonly abused drugs. Participants must be eligible and scheduled for another NIDA-IRP protocol, generally healthy, and age 13 or older.

Design: This study will require 1 visit (approximately 4-6 hours) to the NIDA-IRP, which may be in conjunction with another NIDA-IRP study. The characterization instruments are divided into two sections: Common Instruments and Additional Instruments. Common Instruments include instruments in common with what is done under a similar protocol at NIAAA. All participants will complete these instruments along with the blood sample, Delayed Discounting task and MRI scan. The completion of these items will define a completer of this protocol. Subjects will have the option to complete the study in multiple visits if they choose. After being consented into the study, the participant will be asked to submit a blood sample, complete various questionnaires, characterization instruments and several behavioral tasks. Blood will only be drawn once, provided there are no technical problems (such as sample damage during collection, preparation, shipping or assay) requiring a repeat draw. Participants in more than one NIDA-IRP protocol will be asked to repeat a few of the time-sensitive questionnaires in this protocol during subsequent MRI visits, as required by other IRP imaging protocols in which the subject may be participating. Data acquired in this protocol will be compared to data acquired in other NIDA-IRP protocols.

Outcome Measures: The primary outcome measures in this study are the genetic, behavioral and phenotypic factors that are related to addiction. Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

All participants must be:

  1. eligible for or already enrolled in a NIDA-IRP study.
  2. Greater than or equal to 13 years of age.

EXCLUSION CRITERIA:

Not consented to NIDA IRP imaging protocol. Exclusion criteria are limited to those in the NIDA IRP imaging protocol to which the subject has been consented.

Exclusion for MRI portion:

  1. History of neurological illnesses including but not limited to CVA, CNS tumor, head trauma, MS or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment.
  2. Cognitive impairment (unless this population of subjects is included in another IRP protocol in which the subject is also participating).
  3. Current major mood, anxiety or psychotic disorder (unless this population of subjects is included in another IRP protocol in which the subject is also participating).
  4. Pregnancy.
  5. HIV
  6. Unable to undergo MRI scanning due to possible pregnancy, metallic devices in the body, claustrophobia or body morphometry.
  7. Currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.
  8. Left-handed.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148381


Contacts
Contact: Betty Jo Salmeron, M.D. (443) 740-2651 bsalmeron@intra.nida.nih.gov

Locations
United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC) Recruiting
Baltimore, Maryland, United States, 21224
Contact: For more information contact Mathew's Media Group Recruiting    800-535-8254    researchstudies@mail.nih.gov   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Betty Jo Salmeron, M.D. National Institute on Drug Abuse (NIDA)
  More Information