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Nicotinic Acetylcholine Receptor Agonist

Nicotine Patch for Depression

Phase 2

Recruiting

Led By Warren D Taylor

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Study Summary

This trial will evaluate the effects of Transdermal Nicotine Patches on late-life depression symptoms, cognitive performance, and the Cognitive Control Network.

Who is the study for?

This trial is for people aged 60 or older with major depressive disorder, who have been on a stable dose of certain antidepressants for at least 8 weeks. They must score ≥15 on the MADRS and ≥24 on the MMSE, speak English fluently, and not use tobacco or nicotine in the past year. Exclusions include substance abuse disorders, recent acute grief, other psychiatric disorders except GAD within depression, MRI contraindications, allergy to nicotine patches, and living with smokers.Check my eligibility

What is being tested?

The study tests if Transdermal Nicotine Patches can improve mood and cognitive performance in elderly individuals with depression by enhancing Cognitive Control Network function. It's an open-label extension of a previous blinded study where participants will receive up to 12 weeks of treatment followed by a safety follow-up.See study design

What are the potential side effects?

Potential side effects from using Transdermal Nicotine Patches may include skin irritation at the patch site, dizziness, headache, nausea/vomiting; less commonly palpitations or changes in heart rate could occur due to nicotine's stimulating effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Continuous Performance Task (CPT) Performance

Change in MADRS (Montgomery Asberg Depression Rating Scale) Score

Secondary outcome measures

Apathy Evaluation Scale (AES)

Attentional Control Scale

Choice Reaction Time (CRT) Performance

+9 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT04433767

45%

Skin reaction

17%

Headache

17%

Dizziness

17%

Nausea

10%

Increased tension and inner restlessness

10%

Insomnia

10%

Increased dream activity

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Transdermal Nicotine Patch

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transdermal Nicotine PatchExperimental Treatment1 Intervention

Participants will wear nicotine transdermal patches daily for 12-15 weeks. Participants will apply a study patch each morning and remove at bedtime. Active dose will titrate up from 3.5mg to 7mg, and then can optionally be further titrated to a maximum dose of 14mg. After week12, the dose will be slowly tapered over 2-3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transdermal Nicotine patch

2020

Completed Phase 2

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,133 Total Patients Enrolled

16 Trials studying Depression

854 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,649 Total Patients Enrolled

666 Trials studying Depression

251,524 Patients Enrolled for Depression

Warren D TaylorPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Transdermal Nicotine Patch (Nicotinic Acetylcholine Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05746546 — Phase 2

Depression Research Study Groups: Transdermal Nicotine Patch

Depression Clinical Trial 2023: Transdermal Nicotine Patch Highlights & Side Effects. Trial Name: NCT05746546 — Phase 2

Transdermal Nicotine Patch (Nicotinic Acetylcholine Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746546 — Phase 2

Frequently Asked Questions

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

Has the Transdermal Nicotine Patch been sanctioned by any federal regulatory bodies?

"Transdermal Nicotine Patch is currently in Phase 2 of clinical trials, so our team at Power assigned it a safety rating of 2. This indicates that there are some data supporting its security profile but no evidence backing up efficacy claims yet."

Answered by AI

Has recruitment for this experiment commenced?

"Contrary to expectations, clinicaltrials.gov confirms that this trial has stopped recruiting patients since its last update on February 28th 2023. Nevertheless, 1289 other medical studies are presently seeking subjects."

Answered by AI

What is the aim of this research endeavor?

"As the primary metric for success, this trial will quantify how Change in Continuous Performance Task (CPT) Performance evolves from Baseline to week 12. Additionally, we'll measure Choice Reaction Time (CRT) Performance - a neuropsychological assessment of attention regarding total response time with lower scores indicating better performance - Selective Reminding Task, which gauges immediate and delayed verbal memory through an 8-trial 16 word list; as well as Trait Adjectives Task that judges self-referential negativity bias by quantifying positive adjective endorsement and negative adjectives rejection rates."

Answered by AI