544 Participants NeededMy employer runs this trial

Nicotine Replacement Therapy for Smoking Cessation

DC
Overseen ByDana Carroll, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Masonic Cancer Center, University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people in rural areas quit smoking by exploring different methods to improve success rates. Participants will receive either nicotine patches and lozenges (nicotine replacement therapy) or educational messages about smoking cessation. The trial seeks smokers who live in rural areas, smoke at least 5 cigarettes a day, and use a smartphone or tablet daily.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance smoking cessation strategies in rural communities.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the Nicoderm CQ nicotine patch helps people quit smoking by reducing cravings and withdrawal symptoms. Many users successfully stopped smoking without serious side effects. However, even small amounts of nicotine can harm children, so keep patches away from them.

Research has shown that Nicorette Nicotine Lozenges are generally well tolerated. One study found that both 2 mg and 4 mg lozenges are safe to use and help people quit smoking. Most users did not experience significant side effects.

Both treatments have been widely used and are generally considered safe for adults trying to quit smoking. Always follow the instructions and consult a healthcare provider if there are any concerns.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Nicoderm CQ patches and Nicorette lozenges in a comprehensive nicotine replacement therapy (NRT) approach. Unlike traditional methods, which might focus on just one form of NRT, this trial provides a starter kit with both patches and lozenges, offering flexibility and potentially enhancing the chances of quitting smoking. Additionally, the trial includes supportive weekly messages and easy access to further resources, which could improve adherence and success rates. By comparing these interventions with reduced harm messages and a control group, researchers hope to gather insights on the most effective ways to help people quit smoking.

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

This trial will evaluate the effectiveness of Nicoderm CQ nicotine patches and Nicorette Nicotine Lozenges for smoking cessation. Studies have shown that the Nicoderm CQ nicotine patch significantly aids smoking cessation, with a 27% success rate compared to 13% for placebo users by the end of treatment. After six months, 22% of patch users remained smoke-free, compared to 9% of placebo users. Research found that about 46% of Nicorette Nicotine Lozenge users quit smoking after six weeks, surpassing the 30% quit rate for placebo users. Both treatments, which participants in this trial may receive, help reduce cravings and increase the chances of successfully quitting smoking.16789

Are You a Good Fit for This Trial?

This trial is for adults aged 21 or older who live in rural areas, smoke at least 5 cigarettes a day, and have daily access to their own smartphone or tablet.

Inclusion Criteria

I smoke 5 or more cigarettes daily.
I am at least 21 years old.
I have daily access to my own smartphone or tablet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First Randomization

Participants are randomized to different smoking cessation resources and use them for 3 months

3 months
Surveys at baseline, 1 month, and 3 months

Second Randomization

Participants may be re-randomized to different resources for another 3 months

3 months
Surveys at 1 month and 3 months

Follow-up

Participants are monitored for smoking behavior and abstinence

3 months
CO measurement at 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nicoderm CQ nicotine patch
  • Nicorette Nicotine Lozenges

Trial Overview

The study compares two quit-smoking aids: the Nicoderm CQ nicotine patch and Nicorette nicotine lozenges. Participants will use one of these methods to see which helps people in rural areas quit smoking more effectively.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ConditionExperimental Treatment2 Interventions
Group II: Control ConditionActive Control1 Intervention
Group III: RHE - Intervention ConditionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials
285
Recruited
15,700+

Citations

Nicotine (transdermal route) - Side effects & dosage

Nicotine skin patches are used to help you stop smoking. Nicotine is absorbed from the patch on the skin and enters the blood stream.

Duration and Effectiveness of Nicotine Patch Use

After six months of treatment, researchers found that those still using the patch were significantly more likely to have quit smoking than those ...

3.

pubmed.ncbi.nlm.nih.gov

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

The effectiveness of the nicotine patch for smoking ...

overall abstinence rates for the active patch were 27% (vs 13% for placebo) at the end of treatment and 22% (vs 9% for placebo) at 6 months.

NicoDerm CQ Efficacy | Haleon HealthPartners

NicoDerm CQ doubles your patients' chances of quitting vs. placebo. 4 It provides sustained nicotine delivery over 24 hours to your patients.

The Science Behind the Patch: What Is NicoDerm CQ?

Find out how NicoDerm CQ's nicotine patch helps you quit smoking by delivering therapeutic nicotine through your skin to help prevent nicotine cravings.

NicoDerm CQ Clear Patch Dosing and Administration

Patients should begin using the NicoDerm CQ Patch on their planned quit date according to the dosing schedule as indicated here.

NICODERM CQ- nicotine patch, extended release - DailyMed

Purpose: Stop smoking aid. Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

NICOTINE PATCH (Nicoderm, CQ, others) Fact Sheet [G]

⦁ Patients should be advised to completely stop smoking upon initiation of therapy. Monitoring: No routine monitoring recommended unless clinical picture ...

Nicoderm CQ - accessdata.fda.gov

Derm CQ patch helps smokers quit by reducing nicotine withdrawal symptoms. Many NicoDerm CQ patch users will be able to stop smoking for a few ...