Characterization of Phenotypic and Genotypic Regressors for Imaging

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Jun 19, 2010

Keywords

ClinConnect Summary

This clinical trial is studying how our genes may influence behaviors related to addiction and substance abuse. Researchers want to understand how specific genetic traits can affect things like attention, memory, and decision-making, which are important for understanding addictive behaviors. They will collect genetic information from healthy volunteers and individuals with substance use disorders to see how genetic differences might explain variations in brain imaging results.

To be eligible for the study, participants need to be at least 18 years old and can include healthy individuals, smokers, those dependent on commonly abused drugs, and those with other psychiatric disorders, as long as they are already involved in another research study. Participants can expect to visit the National Institute on Drug Abuse for one or two sessions, where they will provide a blood sample and complete questionnaires about their mood and memory. They may also take part in some simple tasks, like computer games and answering questions. This study aims to help researchers learn more about the role of genetics in addiction, which could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA: Main Study
• All participants must be:
• • -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.
• • -\>= 18 years of age. Justification: Some NIDA-IRP studies have included 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.
• • History of neurological illnesses that per the study clinicians would be significant enough to impair ability to tolerate the procedure or alter neuronal activity, including but not limited to CVA, CNS tumor, head trauma with significant sequelae, Multiple Sclerosis or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment. Participants may also be asked about any lingering neurological and psychiatric symptoms that may be a result of COVID-19 infection. The Medical Advisory Investigator (MAI) will assess the severity in relation to the potential impact on data. Assessment tool: History and physical (H\&P). Rationale: Neurological illnesses may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
• • 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.
• • Inclusion criteria: NIDA CTN Pilot Study
• 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 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
• • 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.