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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 : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )

June 19, 2010
June 22, 2010
October 15, 2018
June 4, 2010
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Complete list of historical versions of study NCT01148381 on ClinicalTrials.gov Archive Site
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Characterization of Phenotypic and Genotypic Regressors for Imaging
Characterization of Phenotypic and Genotypic Regressors

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:

  • 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.

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.

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 under evaluation for another NIDA-IRP protocol, generally healthy, and age 18 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 NIDAIRP 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.

Observational
Time Perspective: Other
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Regressors
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2625
Same as current
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  • INCLUSION CRITERIA: Main Study.

All participants must be:

  1. under evaluation for another NIDA-IRP study or the NIDA CTN pilot portion of this study. Justification: data acquired under other studies will be compared to data collected in this protocol.
  2. greater than or equal to 18 years of age. Justification: Some NIDA-IRP studies have includeed teens, aged 13 - 17, but no current studies include them so we will only include adults in this study for now.

EXCLUSION CRITERIA: Main Study.

Exclusion criteria are limited to those in the NIDA IRP protocol for which the subject is being considered or 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. Assessment tool: phone screen and history and physical (H&P). Rationale: Neurological illnesses may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
  2. Cognitive impairment (unless this population of subjects is included in another IRP protocol in which the subject is also participating). Assessment tool: self-report during H&P, of special education classes, history of specific learning disability or mental retardation. Rationale: Cognitive impairment may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
  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). Assessment tool: self-report, H&P computerized SCID with follow up clinical interview and/or the Mini International Neuropsychiatric Interview (M.I.N.I). Rationale: Current major mood or psychotic disorders may impair ability to tolerate

    the procedures and alter neuronal activity, adding noise to the data.

  4. Pregnancy. Assessment tool: Urine pregnancy test. Rationale: fMRI is not accepted as a safe procedure purely for research purposes during pregnancy.
  5. HIV positive individuals. Assessment tool: oral HIV test with serum confirmation of positive results. Rationale: potential liver/metabolic/vascular disease can interfere with the physiological transduction mechanisms for fMRI (i.e. making the measurement unreliable).
  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. Assessment tool: Edinburgh Handedness Inventory (under screening protocol). Rationale: Differences in hemispheric dominance will be a confound in structural and functional scans.

Inclusion criteria: NIDA CTN Pilot Study

All participants must:

  1. Either have a current DMS-5 nicotine, cocaine, marijuana or opiate use disorder, possibly in combination, or have no current DSM-5 substance use disorder (control participants). Justification: The NIDA CTN has requested pilot data on these participant groups.
  2. Be greater than or equal to 18 years of age. Justification: The NIDA CTN will use this battery in adults.

Exclusion criteria: NIDA CTN Pilot Study

Participants may not have:

  1. A DSM-5 major psychiatric diagnoses unrelated to a substance use disorder including but not limited to bipolar disorder and schizophrenia. Diagnoses secondary to substance use disorder will be allowable providing the participant s symptoms do not interfere with the ability to complete assessments. Assessment tool: self-report, H&P, Mini International Neuropsychiatric Interview (M.I.N.I).

    Rationale: Current major mood or psychotic disorders may impair ability to complete the assessments and would add unnecessary noise to the data.

  2. Cognitive impairment. Assessment tool: self-report during H&P, of special education classes, history of specific learning disability or mental retardation. Rationale: Cognitive impairment may impair ability to complete the assessments and would add unnecessary noise to the data.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Betty Jo Salmeron, M.D. (443) 740-2651 bsalmeron@intra.nida.nih.gov
United States
 
 
NCT01148381
999910457
10-DA-N457
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National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Betty Jo Salmeron, M.D. National Institute on Drug Abuse (NIDA)
National Institutes of Health Clinical Center (CC)
October 10, 2018