Understanding Nicotine's Effects on the Brain in Depression

This study aims to understand how nicotine affects the brain and symptoms of depression (Major Depressive Disorder or MDD). Researchers will compare a Nicotine Patch (7.5 mg) to a placebo nicotine patch in people aged 18 to 60, both with and without MDD, who do not currently use nicotine products. The study will look at how nicotine impacts brain activity during tasks and at rest, and how it affects symptoms of MDD. The goal is to learn why people with depression might be more likely to use nicotine and relapse after quitting. This study is currently recruiting up to 620 participants.

Study design
This is an interventional study where participants will be randomly assigned to receive either a Nicotine Patch or a Placebo Nicotine Patch in a double-blind manner. The planned enrollment is 620 participants.
What's involved
Participants will have 2 or 3 study visits over 1 year, including 2 MRI scans at least 4 days apart. Brain activity and MDD symptoms will be measured at each scan visit.
Compensation
Not stated in the trial record.
Follow-up
Nicotine effects and MDD symptoms, and brain activity will be measured at each scan visit.

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NCT05538910

Defining Neurobiological Links Between Substance Use and Mental Illness

Recruiting
NAAges 18–60InterventionalBasic science
National Institute on Drug Abuse (NIDA)
~620 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Placebo Nicotine PatchNicotine Patch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
4.Nicotine effects and symptoms of MDD
Measured over At each scan visit
+3 more outcomes measured
Major Depressive Disorder
Substance Use Disorder
Normal Physiology
1 sites across 1 states
Maryland1
  • Amy C Janes, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute on Drug Abuse (NIDA)

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  • 4.Nicotine effects and symptoms of MDDAt each scan visit

    Greater expression of MDD symptoms will related to a larger nicotine-induced impact within that domain.

  • 3. Task and Resting State BrainAt each scan visit

    Relate static and temporal dynamic resting state brain function to nicotinic effects.

  • 2.Task-fMRIAt each scan visit

    2\. Evaluate nicotine agonism on: 1) different phases of reward processing, 2) brain/behavioral measures of attentional bias using the classic and emotional Stroop task, and 1.3. 3) interoceptive awareness. 4) confidence on value-based decisions, determine the influence of sex in the context of points 1-3.

  • 1.Resting-fMRIAt each scan visit

    1.Determine the impact of nicotine agonism on the brain s inherent function and organization at rest.