Characterization of Phenotypic and Genotypic Regressors for Imaging
|First Received Date ICMJE||June 19, 2010|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||June 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01148381 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Characterization of Phenotypic and Genotypic Regressors for Imaging|
|Official Title ICMJE||Characterization of Phenotypic and Genotypic Regressors for MRI|
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.
- To collect genetic information for research on genetic aspects of addiction and substance abuse.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||2625|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All participants must be:
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:
|Ages||13 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01148381|
|Other Study ID Numbers ICMJE||999910457, 10-DA-N457|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2013|
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