| Eligibility |
- 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. Assessment tool: phone screen and history and physical (H and
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 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, validated IQ test, such as Wechsler Abbreviated Scale of
Intelligence (WASI) or Shipley-2. 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 in which the subject is also participating).
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) 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.
- 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.
- Suspected or confirmed active SARS-CoV-2 infection. Assessment tool: 2019 Novel
Coronavirus (COVID-19) patient screening tool administered by phone prior to
participant arrival. The current version of the screening tool to be used is available
at http://intranet.cc.nih.gov/hospitalepidemiology/emerging_infectious_diseases.html).
Viral testing looking for SARS-CoV-2 in a specimen deemed appropriate by NIH such as
nasopharyngeal or midturbinate swab. We reserve the right to change the specimen type
as NIH approves new test procedures. This test may be carried out in-house at NIDA,
NIH, at a community testing site or through a commercial vendor. Anyone with a
positive symptom screen without a clear alternative explanation or a positive viral
test will be excluded until they recover or (for asymptomatic cases) are no longer
infectious. Additionally, participants will be asked about any lingering neurological
and psychiatric symptoms such as difficulty with memory or concentration, changes in
mood or new anxiety symptoms that may be a result of COVID- 19 exposure. The MAI will
evaluate any lingering symptoms to determine whether the potential impact on data is
compatible with continuing in the study. MAI will also retain the ability to exclude
for a suspicious symptom screen without positive viral test. Rationale: Covid-19 is
extremely infectious and can have serious consequences. Allowing participants with
active infection would alter the risk:benefit ratio for non-treatment studies without
a primary focus on SARS-CoV-2 to an unacceptable level of risk. In addition, Covid-19
can have cognitive consequences which would add unnecessary noise to the study data.
Screening and testing will continue as long as public health officials and/or NIDA
medical personnel deem it appropriate.
- 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, WASI.
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.
4. Suspected or confirmed active SARS-CoV-2 infection. Assessment tool: 2019 Novel
Coronavirus (COVID-19) patient screening tool administered by phone prior to
participant arrival. The current version of the screening tool to be used is available
at http://intranet.cc.nih.gov/hospitalepidemiology/emerging_infectious_diseases.html).
Viral testing looking for SARS-CoV-2 in a specimen deemed appropriate by NIH such as
nasopharyngeal or mid- turbinate swab. We reserve the right to change the specimen
type as NIH approves new test procedures. This test may be carried out in-house at
NIDA, NIH, at a community testing site or through a commercial vendor. Anyone with a
positive symptom screen without a clear alternative explanation or a positive viral
test will be excluded until they recover or (for asymptomatic cases) are no longer
infectious. MAI will also retain the ability to exclude for a suspicious symptom
screen without positive viral test. Rationale: Covid-19 is extremely infectious and
can have serious consequences. Allowing participants with active infection would alter
the risk:benefit ratio for non- treatment studies without a primary focus on
SARS-CoV-2 to an unacceptable level of risk. In addition, Covid-19 can have cognitive
consequences which would add unnecessary noise to the study data. Testing will
continue as long as public health officials and/or NIDA medical personnel deem it
appropriate.
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