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PET Imaging with [18F]VAT to Study Nicotine's Effect on Depression

This study is looking into how nicotine affects depression and certain brain cells. Researchers are using a brain imaging technique called a PET scan with a special tracer, [18F]VAT, to see how these brain cells work. Participants with Major Depressive Disorder (MDD) will receive Nicorette NicoDerm CQ nicotine patches for 8 days, with the dose gradually increasing. You would have a PET scan before starting the nicotine patches and another one after the 8 days of treatment. The main goal is to see if the nicotine patches change your depression symptoms, measured by a standard depression scale. The study is currently unclear on its recruitment status and plans to enroll 14 people between 18 and 65 years old.

Study design
This is an interventional study with 14 planned participants. It involves giving a treatment (nicotine patches) and observing its effects.
What's involved
If you have MDD, you would receive Nicorette NicoDerm CQ nicotine patches for 8 days. All participants will have two PET scans with [18F]VAT, one before and one after the 8-day treatment period.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured before and after 8 days of treatment with nicotine.

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NCT07095205

PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Stony Brook University
~14 participants
Updated 2025-07-31 on ClinicalTrials.gov
What's tested:Nicotine transdermal patchPET Scan with [18F] VAT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hamilton Depression Rating Scale-17 (HAMD) score.
Measured over Before and after 8 days of treatment with nicotine.

Conditions

Major Depressive Disorder (MDD)

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Unipolar Depression

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ramin Parsey, MD, PhD · PRINCIPAL_INVESTIGATOR · Stony Brook University

Who to contact

Julianna Lizzul
[email protected]
631-638-0291
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age range 18 to 65 years old.
Capacity to consent (able to read, understand, and sign informed consent).
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

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.
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.

What this trial measures

  • Change in Hamilton Depression Rating Scale-17 (HAMD) score.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.