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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ ongoing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
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 moreSecondary 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
2,582 Previous Clinical Trials
3,326,620 Total Patients Enrolled
Amy Janes, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
4 Previous Clinical Trials
934 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have thoughts of harming myself and need more than outpatient care.I haven't taken any anticholinergic or dopamine-enhancing drugs in the last week.I have never been diagnosed with major depressive disorder.I have had a brain injury, illness, or an abnormal brain scan.I do not have any serious or unstable illnesses.I am between 18 and 60 years old.I do not have any major health, brain, or mental health issues.I haven't taken any mental health medication for 2 weeks, except for my stable SSRI/SNRI.I cannot speak English.My depression is currently in full remission.I haven't taken any psychotropic drugs in the last 2 weeks, except for SSRIs/SNRIs for non-mood disorders.I have had serious heart, brain, or lung conditions.I have had a learning disability that needed help during my school years.I haven't taken any mental health medication except for a stable dose of SSRI/SNRI in the last 2 months.I do not have any major medical, neurological, psychiatric illnesses, or depression.You have a current diagnosis of major depressive disorder (MDD) based on DSM-5 criteria at the time of screening.I am generally healthy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Placebo
- Group 2: Arm 2: Nicotine Patch
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Substance Use Disorder Patient Testimony for trial: Trial Name: NCT05538910 — N/A
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