1550 Participants NeededMy employer runs this trial

Nicotine Patch + Counseling for Smoking Cessation

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black adults quit smoking by evaluating different methods using nicotine patches and counseling. Participants will divide into three groups: one receives standard support, another gets more intensive help, and the third group receives extra incentives for completing sessions. Researchers will compare each method's effectiveness to determine which best supports long-term quitting. The trial suits individuals who self-identify as Black, smoke regularly, want to quit, and are willing to pause other stop-smoking medicines during the study. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

You will need to stop using any non-study smoking cessation medications while participating in the trial. If you are taking bupropion for reasons other than quitting smoking, you cannot join the study.

What is the safety track record for these treatments?

Research shows that the nicotine patch is generally safe for adults who smoke. Studies have found that it does not significantly increase the risk of heart problems, even for individuals with heart disease. However, users may experience skin irritation, such as redness or itching, at the application site. This side effect is common but usually not serious.

The nicotine patch helps reduce withdrawal symptoms by releasing small amounts of nicotine through the skin. It is considered safe for both short-term and long-term use, with some research suggesting it can be used safely for up to a year. Following the instructions when using the patch minimizes any risks.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for smoking cessation because they combine nicotine replacement therapy with personalized counseling, offering a more comprehensive approach than the standard nicotine patch or gum alone. The Intensive Intervention adds a choice of individual phone or virtual group sessions, plus engaging content like the Pathways to Freedom videos, which aim to bolster motivation and provide ongoing support. The Intensive Incentivized Intervention goes a step further by rewarding participants financially for completing counseling sessions, potentially increasing adherence and success rates. This multi-faceted strategy could offer smokers a more engaging and supportive path to quitting compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that nicotine patches can double the chances of quitting smoking compared to patches without nicotine. One study found that people using nicotine patches were more than twice as likely to quit smoking. Success rates for quitting long-term, such as for 6 to 12 months, were significantly higher with the patch. This trial will compare different interventions, including the Standard Intervention with 2 weeks of nicotine patches and counseling, and the Intensive Intervention with 8 weeks of patches and additional support. Combining the patch with counseling can further improve the chances of success. Overall, the nicotine patch is a proven and effective method to help individuals quit smoking.678910

Who Is on the Research Team?

MP

Megan Piper, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for Black adults who smoke cigarettes at least 4 days a week, want to quit smoking, and are willing to stop using any other quit-smoking medications during the study.

Inclusion Criteria

* self-identify as Black
* smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
* motivated to quit smoking
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three interventions: Standard, Intensive, or Intensive Incentivized, involving nicotine patches and counseling sessions

8 weeks
8 counseling sessions (phone or virtual)

Follow-up

Participants are monitored for smoking cessation and other outcomes post-treatment

26 weeks
Assessments at 8 and 26 weeks post-TQD

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotine patch

Trial Overview

The study compares three approaches: standard state-run quitline support, more intensive culturally tailored counseling (with or without monetary incentives), and nicotine patches. The goal is to see which method helps people quit smoking long-term.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Intensive InterventionExperimental Treatment3 Interventions
Group II: Intensive Incentivized InterventionExperimental Treatment4 Interventions
Group III: Standard InterventionActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/8201739/

The effectiveness of the nicotine patch for smoking ...

Active patch subjects were more than twice as likely to quit smoking as individuals wearing a placebo patch, and this effect was present at both high and low ...

Effectiveness of Nicotine Replacement Therapy and ...

While robust evidence indicates that NRT successfully achieves prolonged smoking abstinence, uncertainties persist regarding the potential ...

A comparison of measures used to assess effectiveness ...

The patch doubles abstinent rates after 6 and 12 months and has proven to be effective in combination with group cognitive behavioral interventions.23-27 The ...

The effectiveness of the nicotine patch for smoking cessation

The nicotine patch is an effective aid to quitting smoking across different patch-use strategies. Active patch subjects were more than twice as likely to quit ...

Psilocybin or Nicotine Patch for Smoking Cessation: A Pilot ...

Biologically verified 7-day point prevalence abstinence rates were 80%, 67%, and 60% at 6, 12, and 30 months after the target quit date, ...

Adverse events associated with nicotine replacement therapy ...

Pooled evidence specific to the NRT patch found an increase in skin irritations (OR 2.80, 95% CO, 2.28-3.24, P < 0.001). Orally administered NRT was associated ...

Nicotine (transdermal route) - Side effects & dosage

Safety and efficacy have not been established. Small amounts of nicotine can cause serious unwanted effects in children, and patches contain ...

The Safety of Transdermal Nicotine as an Aid to Smoking ...

Transdermal nicotine does not cause a significant increase in cardiovascular events in high-risk outpatients with cardiac disease.

Study: Nicotine patch safe for smokers while hospitalized ...

Nicotine replacement therapy appears to be a safe option for smokers hospitalized for heart disease, even for critically ill patients on their first day, ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/9821833/

Efficacy and safety of an over-the-counter transdermal ...

Conclusions: When the nicotine patch was used in an over-the-counter setting, quit rates were comparable to those reported for medical settings. A 2:1 quit rate ...