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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1.Resting-fMRI

2.Task-fMRI

3. Task and Resting State Brain

+1 more

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor

2,468 Previous Clinical Trials

2,618,928 Total Patients Enrolled

Amy Janes, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)

4 Previous Clinical Trials

934 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a possibility for me to partake in this experimentation?

"This experimental intervention is open to 420 individuals aged between 18-60 with Major Depressive Disorder (MDD). To be eligible, the prospective patient must be willing and able to give written informed consent that includes a commitment to all lifestyle considerations. They also need to have current MDD as determined by their baseline Hamilton Depression Scale score, meet DSM-5 criteria for remitted MDD, possess general good health without pregnancy or breastfeeding, register zero alcohol levels on days involving scans, not take psychotropic medications two weeks prior at least apart from stable SSRI/SNRI therapies unchanged in the past two months. Further details can be found in documents"

Answered by AI

Is the elderly demographic being given access to this research initiative?

"This clinical trial seeks patients aged 18 to 60. Exclusively, there are 471 trials directed at minors and 1453 for elderly individuals above 65 years of age."

Answered by AI

Are any fresh volunteers being sought for this trial at the present time?

"Affirmative. The information available on clinicaltrials.gov indicates that the study is currently recruiting and was first posted on December 11th 2022; last updated five days later. 420 patients are needed from 1 site to participate in this trial."

Answered by AI

What is the current number of participants in this research endeavor?

"Confirmed. According to information on clinicaltrials.gov, this research initiative is actively seeking participants and was initially posted on December 11th 2022 with the most recent update being December 5th 2022. The study seeks 420 volunteers from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?

Maryland

What site did they apply to?

National Institute on Drug Abuse

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I've tried countless treatments for depression over the past 20 years. Nothing seems to work well enough. I'm currently on Cymbalta, but it's only bringing partial relief.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Defining Neurobiological Links Between Substance Use and Mental Illness

2023. "Defining Neurobiological Links Between Substance Use and Mental Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538910.

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