NCT07095205 · Stony Brook University
PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.
(VATMDDNicotine)
What this study is about
In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells.
View original scientific description
In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.
Interventions
DRUG
Nicotine transdermal patch
The participants with MDD will receive Nicorette NicoDerm CQ nicotine transdermal patches for 8 days (7 mg/day for days 1-2, 14 mg/day for days 3-4, and 21 mg/day for days 5-8).
DRUG
PET Scan with [18F] VAT
All participants will undergo a PET scan at Baseline using tracer \[18F\] VAT. Participants with MDD will undergo a second post-treatment PET scan using tracer \[18F\] VAT.
Primary outcome measures
Change in Hamilton Depression Rating Scale-17 (HAMD) score.
Time frame: Before and after 8 days of treatment with nicotine.
Description: Comparison of Hamilton Depression Rating Scale-17 score at pretreatment and post-treatment. Minimum score 0, maximum possible score 52, with remission defined as \<=7. The higher the score on the scale, the more severe the degree of depression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For Non-Depressed Participants:
- Age range 18 to 65 years old.
- Capacity to consent (able to read, understand, and sign informed consent). For Participants with MDD
- Age range 18 to 65 years old.
- Capacity to consent (able to read, understand, and sign informed consent).
- Major Depressive Disorder (MDD) as primary diagnosis and currently in a major depressive episode
- Score of at least 29 on the Montgomery-Asberg Depression Rating Scale (MADRS).
Exclusion criteria
- For Non-Depressed Participants:
- Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \[except for occasional users, who cannot use nicotine products in the week before the scan\].
- Need for use of medication during the study that will affect cholinergic levels.
- Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
- Significant active physical illness or neurological deficit that may affect brain function or imaging.
- Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
- Current or lifetime history of a major psychiatric diagnosis.
- Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
- Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
- Blood donation within 8 weeks of the \[18F\]VAT scan. For Participants with MDD
- Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \[except for occasional users, who cannot use nicotine products in the week before the scan\].
- Currently on effective antidepressant medications or need for use of medications that target the cholinergic system.
- Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
- Significant active physical illness or neurological deficit that may affect the brain function or imaging.
- Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
- Current or lifetime major psychiatric diagnosis other than MDD.
- Life-time history of psychosis or current psychosis.
- Significant risk for suicide.
- Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
- Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
- Blood donation within 8 weeks of the \[18F\]VAT scan.
Where
- Stony Brook, New York
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations