Defining Neurobiological Links Between Substance Use and Mental Illness (NCT05538910) | Clinical Trial Compass
RecruitingNot Applicable
Defining Neurobiological Links Between Substance Use and Mental Illness
United States620 participantsStarted 2023-02-02
Plain-language summary
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 recent use of alcohol, nicotine, and illegal drugs.
Before each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan.
For each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours.
Participants will answer questions about their thoughts, feelings, and behaviors before and after each scan.
They will have a blood test after each scan.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able and willing to provide written informed consent.
. Both sexes and all ethnic origins, age between 18 and 60 at the time of consent. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.
. Be generally healthy
. Absence of pregnancy and breastfeeding. Justification: study procedures and drugs used in the current protocol may complicate pregnancy or be transferred to nursing children. Assessment tool(s): Urine and/or serum pregnancy tests, and clinical interview. Urine pregnancy tests will also be conducted at the beginning of each imaging visit.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study involves brain imaging and tasks related to nicotine effects alongside Major Depressive Disorder symptoms — given my current mental health situation, is this kind of observational research something that could affect my ongoing treatment or emotional wellbeing?
2Since this trial is listed as 'Phase NA,' which means it's a research study rather than a treatment trial, can you help me understand whether participating would give me any direct benefit, or is it purely to help researchers learn more about the connection between depression and substance use?
3The study measures brain activity at rest and during tasks using fMRI — do I need to be a current nicotine or substance user to be eligible, and how might my specific history with depression or substance use affect whether this study is even a good fit for me?
4Because this is a neurobiological research study and not a treatment trial, should I be pursuing other standard treatment options for my depression at the same time, and would participating in this study interfere with any of those?
5The trial is actively recruiting right now — before I consider it, can you walk me through what the actual time commitment and procedures would look like for me, including how many visits, what the imaging sessions involve, and whether there are any risks I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Meet DSM-5 diagnostic criteria for current MDD at screening Clinical judgement will be used to interpret criteria.
. Have a baseline (Hamilton Depression) HAM-D score indicative of current depression as evaluated by clinical staff.
. 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
Exclusion criteria
. Subjects with suicidal ideation where outpatient treatment is determined unsafe.
. 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
. 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.
. 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.
. May not have regularly used any nicotine product in the past year; must never have been daily nicotine users for more than 1 month.
. 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.
. History of moderate or severe substance use disorder in the past 6 months (other than caffeine)
. Current pharmacological treatment for opioid use disorder (i.e., use of methadone)