Characterization of Phenotypic and Genotypic Regressors for Imaging
NCT ID: NCT01148381
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
847 participants
OBSERVATIONAL
2010-11-18
Brief Summary
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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 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.
Detailed Description
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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 5-8 hours. 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. If participants enroll in other NIDA-IRP imaging protocols, they will be asked to repeat a few of the time- sensitive questionnaires in this protocol during the MRI visits of the other protocols. 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. The CTN Pilot procedures require approximately 4-6 hours to complete.
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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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controls
healthy non-smoking, participants with no substance use disorders
No interventions assigned to this group
psychiatric disorders
individuals with other psychiatric disorders
No interventions assigned to this group
smokers
healthy individuals with nicotine use disorder
No interventions assigned to this group
substance use disorders
healthy individuals with other substance use disorders
No interventions assigned to this group
treatment seeking individuals
treatment seeking individuals with substance use disorders
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
-under evaluation for or enrolled in another NIDA-IRP study. Justification: This protocol is primarily meant to gather uniform characterization data on IRP participants although the data is useful regardless of participation in other protocols.
-\>= 18 years of age. Justification: The majority of NIDA-IRP studies only include adults, as such, we will only include adults in this study for now.
All participants must:
1. Either have a current DSM-5 diagnosis for at least one of the following substance use disorders: nicotine, cocaine, marijuana, opiate; or 2) no current DSM-5 substance use disorder (control participants). Justification: These criteria are consistent with the scope of this study to pilot this battery of tests for future use in similar populations enrolled in the NIDA CTN studies.
2. Be \>= 18 years of age. Justification: The NIDA CTN will use this battery in adults.
Exclusion Criteria
* Cognitive impairment (unless this population of subjects is included in another IRP protocol for which the subject is also under consideration). Assessment tool: self-report during H\&P of special education classes, history of specific learning disability or mental retardation. A validated IQ test such as the Shipley-2 may also be administered. Rationale: Cognitive impairment may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
* Current major mood, anxiety or psychotic disorder (unless this population of subjects is included in another IRP protocol for which the subject is also under consideration). Assessment tool: self-report, H\&P, a structured or semi-structured psychiatric interview such as the computerized SCID with follow up clinical interview (or full interviewer-administered). Rationale: Current major mood or psychotic disorders may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
* Pregnancy. Assessment tool: Urine pregnancy test. Rationale: fMRI is not accepted as a safe procedure purely for research purposes during pregnancy.
* 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).
* Unable to undergo MRI scanning due to possible pregnancy, metallic devices in the body, claustrophobia or body morphometry.
* Currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.
* Non-English speaking. Assessment tool(s): self-report. Rationale: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing study procedures. The inability to effectively communicate safety procedures in a language other than English could compromise the safety of non-English speaking participants.
* Other health conditions that would impact safety of participation or scientific integrity of data collection.
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, structured or semi-structured psychiatric interview.
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. A validated IQ test such as the Shipley-2 may also be administered. Rationale: Cognitive impairment may impair ability to complete the assessments and would add unnecessary noise to the data.
3. Non-English speaking. Assessment tool(s): self-report. Rationale: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing study procedures. The inability to effectively communicate safety procedures in a language other than English could compromise the safety of non-English speaking participants.
18 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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Principal Investigators
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Amy C Janes, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Drug Abuse (NIDA)
Locations
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National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States
Countries
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Other Identifiers
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10-DA-N457
Identifier Type: -
Identifier Source: secondary_id
999910457
Identifier Type: -
Identifier Source: org_study_id