Characterization of Phenotypic and Genotypic Regressors for Imaging
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|ClinicalTrials.gov Identifier: NCT01148381|
Recruitment Status : Recruiting
First Posted : June 22, 2010
Last Update Posted : August 6, 2019
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.
Adults age 18 or older
- (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.
- 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 or disease|
|Healthy Volunteers Substance Abuse Disorders|
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, participants with no substance use disorders 2) healthy individuals with nicotine use disorder 3) healthy individuals with other substance use disorders 4) individuals with other psychiatric disorders and 5) treatment-seeking individuals with substance use disorders. Participants must be under evaluation for another NIDA-IRP protocol, generally healthy, and age 18 or older.
Design: The main study will require approximately 4-6 hours at the NIDA-IRP. Main study procedures may be done in 1 visit or multiple visits, and may be done in conjunction with another NIDA-IRP study. After being consented into the main study, the participant will be asked to submit a blood sample, an MRI scan, 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.
An arm of this protocol will be used to pilot test a phenotyping battery developed by the NIDA CTN. This battery overlaps with several of the assessments in the main protocol. Participants in the NIDA CTN pilot study who also meet criteria for the main study may participate in the main study as well.
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 :||Observational|
|Estimated Enrollment :||2625 participants|
|Official Title:||Characterization of Phenotypic and Genotypic Regressors|
|Study Start Date :||June 4, 2010|
healthy non-smoking, participants with no substance use disorders
individuals with other psychiatric disorders
healthy individuals with nicotine use disorder
substance use disorders
healthy individuals with other substance use disorders
treatment seeking individuals
treatment seeking individuals with substance use disorders
- The primary outcome measures are the genetic, behavioral and phenotypic factors that are related to addiction. [ Time Frame: each visit ]To determine whether genetic polymorphisms, phenotypic measures and behavioral characterization instruments can explain variance in structural and functional imaging data and in behavioral outcome measures such as treatment outcome or substance use trajectories or patterns as collected under other NIDA IRP protocols and clinical trials conducted in the NIDA CTN.
- Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols. [ Time Frame: each visit ]To compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols
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
|Contact: Betty Jo Salmeron, M.D.||(443) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Betty Jo Salmeron, M.D.||National Institute on Drug Abuse (NIDA)|