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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

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I manage my own finances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in quit attempts

Change in self-reported abstinence from cigarettes

Change in self-reported use of electronic nicotine delivery systems use

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

0 / 2Eligibility criteria met