Characterization of Phenotypic and Genotypic Regressors for Imaging (NCT01148381) | Clinical Trial Compass
CompletedNot Applicable
Characterization of Phenotypic and Genotypic Regressors for Imaging
United States847 participantsStarted 2010-11-18
Plain-language summary
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 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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. 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.
✕. Be \>= 18 years of age. Justification: The NIDA CTN will use this battery in adults.
✕. 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.
What they're measuring
1
The primary outcome measures are the genetic, behavioral and phenotypic factors that are related to addiction.
. 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.
✕. 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.