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Nicotine Replacement Therapy Agent

Financial Counseling + Nicotine Replacement for Smoking Cessation

Phase 3
Recruiting
Led By Erin Rogers, DrPH
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Does not have a representative who manages his/her funds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights

Study Summary

This trial will study whether adding financial counseling to standard smoking cessation counseling can help smokers quit.

Who is the study for?
This trial is for smokers over 18 living in New York City, earning below twice the federal poverty level, and smoking at least 5 cigarettes a day. They must speak English or Spanish, be able to consent, manage their own funds, and want help quitting smoking and managing finances. Pregnant women, recent heart attack patients, those with certain heart conditions or nicotine patch allergies can't join.Check my eligibility
What is being tested?
The study compares two approaches: (1) Standard Smoking Cessation Counseling alone (Control group), versus (2) Integrated Financial-Smoking Cessation Counseling which combines financial advice with quit-smoking support (Intervention group). It's a randomized controlled trial involving 900 participants divided equally between both groups.See study design
What are the potential side effects?
Nicotine replacement therapies like patches, lozenges, and gum may cause skin irritation where applied, mouth issues for lozenges/gum users such as soreness or hiccups; headaches; nausea; dizziness; coughing; sleep disturbances including vivid dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I manage my own finances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration)
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine)
Secondary outcome measures
Change in quit attempts
Change in self-reported abstinence from cigarettes
Change in self-reported use of electronic nicotine delivery systems use

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Financial-Smoking Cessation CoachingExperimental Treatment4 Interventions
The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
Group II: Standard Smoking Cessation CoachingActive Control3 Interventions
Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,400 Total Patients Enrolled
63 Trials studying Smoking
53,982 Patients Enrolled for Smoking
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,605 Total Patients Enrolled
6 Trials studying Smoking
493 Patients Enrolled for Smoking
Erin Rogers, DrPHPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Nicotine Replacement Therapy Agent - Gum (Nicotine Replacement Therapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05154669 — Phase 3
Smoking Research Study Groups: Integrated Financial-Smoking Cessation Coaching, Standard Smoking Cessation Coaching
Smoking Clinical Trial 2023: Nicotine Replacement Therapy Agent - Gum Highlights & Side Effects. Trial Name: NCT05154669 — Phase 3
Nicotine Replacement Therapy Agent - Gum (Nicotine Replacement Therapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05154669 — Phase 3

Frequently Asked Questions

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

Are we able to enroll anyone above the age of 18 in this research?

"To be eligible for this particular clinical trial, applicants must between 18 and 100 years of age. There are 4 separate trials for minors and another 55 ongoing studies for elderly patients."

Answered by AI

Are we still recruiting participants for this research project?

"No, this particular study is not currently accepting patients. The listing on clinicaltrials.gov shows that the last update to this trial was on September 30th, 2022. There are, however, 65 other active studies enrolling patients right now."

Answered by AI

How do I sign up for the clinical trial?

"In order to be eligible for this study, candidates must:-Be between 18 and 100 years old-Currently smoke cigarettes-Meet the following criteria: New york City resident, smokes ≥5 cigarettes per day, age ≥18 years, interested in receiving smoking and financial counseling, does not have a representative who manages his/her funds."

Answered by AI

Has the FDA cleared nicotine replacement therapy agent - lozenges for public consumption?

"There is some evidence from past clinical trials to support the efficacy of Nicotine Replacement Therapy Agent - Lozenges, and it has received a score of 3 for safety."

Answered by AI

Who else is applying?

What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Integrating Financial Coaching and Smoking Cessation Coaching
2022. "Integrating Financial Coaching and Smoking Cessation Coaching". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05154669.
All > Smoking Cessation
~78 spots leftby Oct 2026
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