Caratterizzazione dei regressori fenotipici e genotipici per l'imaging

For the main study, subjects will be recruited from the pool of subjects who are being considered for other NIDA-IRP protocols. Therefore, participant distribution in the main study will reflect that specified in other NIDA-IRP protocols. No preferences in participant recruitment will be made on the basis of sex, race, or ethnic background. In both the main study and the CTN pilot, efforts will be made to include ethnic minorities in proportion to their presence in the Baltimore City area, which is where the majority of our subjects reside.

• INCLUSION CRITERIA: Main Study

All participants must be:

-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: 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. 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 >= 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.