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Nicotine Patch for Depression

N/A
Recruiting
Led By Amy Janes, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each scan visit

Summary

This trial is testing how nicotine affects symptoms of depression and related brain function. People aged 18 to 60 who do not smoke or use nicotine products are eligible. Participants will have 3 or 4 study visits over 1 to 4 months. Each visit will include urine and breath tests, 3 MRI scans, and a blood test.

Who is the study for?
This trial is for adults aged 18-60, with or without Major Depressive Disorder (MDD), who don't smoke or use nicotine products. Participants should be generally healthy and not pregnant. Those with MDD can be on stable SSRI/SNRI medications, while control participants must have no current/lifetime MDD diagnosis.
What is being tested?
The study tests how nicotine affects depression symptoms and brain function in individuals with MDD compared to healthy controls. It involves MRI scans after taking either a placebo or a real nicotine patch, without knowing which one they've received.
What are the potential side effects?
Possible side effects from the nicotine patch may include skin irritation at the patch site, dizziness, headache, nausea, and sleep disturbances. The placebo is unlikely to cause any direct side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1.Resting-fMRI
2.Task-fMRI
3. Task and Resting State Brain
+1 more
Secondary study objectives
Determine the relationship between blood-based biomarkers, such as inflammatory makers/metabolomics and nicotinic effects

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2: Nicotine PatchExperimental Treatment1 Intervention
Nicotine Patch + Placebo Pill
Group II: Arm 1: PlaceboPlacebo Group1 Intervention
Placebo patch + Placebo Pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Patch
2011
Completed Phase 4
~10480

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,607 Previous Clinical Trials
3,329,515 Total Patients Enrolled
Amy Janes, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
4 Previous Clinical Trials
463 Total Patients Enrolled

Media Library

Arm 2: Nicotine Patch Clinical Trial Eligibility Overview. Trial Name: NCT05538910 — N/A
Substance Use Disorder Research Study Groups: Arm 1: Placebo, Arm 2: Nicotine Patch
Substance Use Disorder Clinical Trial 2023: Arm 2: Nicotine Patch Highlights & Side Effects. Trial Name: NCT05538910 — N/A
Arm 2: Nicotine Patch 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538910 — N/A
Substance Use Disorder Patient Testimony for trial: Trial Name: NCT05538910 — N/A
~261 spots leftby Dec 2027