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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Defining Neurobiological Links Between Substance Use and Mental Illness
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Amy C Janes, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute on Drug Abuse (NIDA)
Who to contact
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What this trial measures
- 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.