💬In plain words
What the trial is, and whether it could suit you
Background:
Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD.
Objective:
To understand how nicotine affects symptoms of depression and related brain function.
Eligibility:
People aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products.
Design:
Participants will have 2 or 3 study visits over 1 year.
Participants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recen
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📋 Eligibility rules (as published)
* INCLUSION CRITERIA:
To be eligible for this study, an individual must meet all the following criteria assessed under the currently approved NIDA IRP screening protocol for the evaluation of potential research subjects (here referred to as the NIDA screening protocol). This is a protocol led by the Office of the Clinical Director (OCD) at the National Institute on Drug Abuse Intramural Research Program (NIDA IRP) to assess potential research participants eligibility for entering clinical protocols at the NIDA/IRP. Additional details can be found in the NIDA screening protocol documents. As routinely done at the NIDA IRP, the screening procedures and data collected under the NIDA
screening protocol will capture information above and beyond what is necessary to determine eligibility for this protocol but allows the Investigators to assess the eligibility criteria for this protocol.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
All Participants:
1. Able and willing to provide written informed consent.
2. Both sexes and all ethnic origins, age between 18 and 60 at the time of consent.
3. Absence of pregnancy and breastfeeding.
4. Have a Breath Alcohol Value of 0 on all study visit days involving scanning. Participant may be rescheduled if this value is greater than 0.
MDD Subjects:
1. Meet DSM-5 diagnostic criteria for current MDD at screening Clinical judgement will be used to interpret criteria.
2. Have a baseline (Hamilton Depression) HAM-D score indicative of current depression as evaluated by clinical staff.
3. Current stable serotonin modulating drug (e.g. SSRI/SNRI/serotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI
Remitted MDD Subjects:
1. Meet DSM-5 diagnostic criteria for remitted MDD (full remission or partial remission or past depression) Clinical judgement will be used to interpret criteria.
2. HAM-D score indicating no clinically relevant depression as evaluated by clinical staff.
3. Current stable serotonin modulating drug (e.g. SSRI/SNRI/serotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI.
Control Subjects (without MDD):
1. Control participants must not have current/lifetime MDD. Clinical judgement will be used to interpret criteria.
2. HAM-D score indicating no clinically-relevant depression as evaluated by clinical staff.
Daily Nicotine Users (Study Arm 2):
1. Uses nicotine daily for at least six months
2. Positive urine screen for cotinine
EXCLUSION CRITERIA (STUDY ARM 1):
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Subjects with suicidal ideation where outpatient treatment is determined unsafe.
2. Lifetime history or current diagnosis of any of the following psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features. The MAI and/or PI/LI will reserve the right to exclude based psychiatric history not explicitly described in this criterion
a. Within the control group, current use of antidepressants for psychiatric reasons will be exclusionary. The MAI reserves the right to evaluate use of antidepressants for non-psychiatric uses as appropriate for participation in the study.
3. Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI will reserve the right to evaluate if a participant s history of educational placement is likely to represent a learning disability that could significantly impact the data gathered in this study based on the severity and type of learning disability. Justification: Cognitive impairment and learning disabilities may be associated with altered brain functioning in regions recruited during laboratory task performance.
4. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). Participants will be asked to not deviate from their typical caffeine use on all scanning days.
5. May not have used any nicotine product weekly or more frequently than weekly in the past year; must never have been daily nicotine users for more than 1 month.
6. Must have an expired carbon monoxide level of less than or equal to 5 ppm and cotinine levels consistent with a non-smoker. Depending on the commercially available test used, a level equivalent to a non-smoker status will be used, ideally indicative of a urine cotinine level of around 10 ng/ml. However, given the known limitations of rapid tests to return specific quantifications of cotinine levels, if the present test is unable to quantify cotinine at this level, the lowest level of detection will be used as a cut off and MAI/PI discretion may be used to determine whether this cut off coupled with participant history and environmental factors indicates personal nicotine use versus secondhand smoke environment. If expired carbon monoxide level is greater than 5 ppm and cotinine levels consistent with a non-smoker, the MAI/PI will reserve the right to assess the participant's full clinical picture to determine the source of CO readings over 5 ppm. If the source is unlikely to be from personal nicotine use (e.g., negative cotinine test and participant states exposure to secondhand smoke environment, etc.), the CO test may be re-run until a lower reading is obtained, or the participant can be rescheduled.
7. History of moderate or severe substance use disorder in the past 6 months (other than caffeine)
8. Current pharmacological treatment for opioid use disorder (i.e., use of methadone)
9. Current use of illegal drugs other than marijuana as measured by urine drug screen Marijuana will
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