Nicotine Replacement Therapy for Quitting Smoking

Overseen By Bradley End, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: West Virginia University

Disqualifiers: Medically unstable, Uncontrolled psychiatric, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of nicotine replacement therapy (NRT) in helping people quit smoking when initiated in the emergency department. Participants will receive either NRT, which includes products like nicotine patches or gum, or standard advice and support for quitting smoking. The trial aims to determine if NRT increases the number of people who quit smoking after 2 weeks, 1 month, and 3 months compared to usual methods. Eligible participants smoke at least half a pack of cigarettes daily, are ready to leave the emergency room, and can follow up by phone or online. As a Phase 4 trial, this study uses an FDA-approved treatment to understand its benefits for more patients, offering a proven method to help quit smoking.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Nicotine Replacement Therapy?

Previous studies have shown that nicotine replacement therapy (NRT) is safe for helping people quit smoking. Research shows that while NRT can cause some side effects, they are usually mild and not harmful. Common side effects include headaches, dizziness, and an upset stomach, which are generally manageable and resolve on their own.

NRT is widely used and nearly doubles the chances of quitting smoking compared to not using it. It provides a small, controlled amount of nicotine to help manage cravings and withdrawal symptoms, making it easier to quit smoking.

Overall, NRT is well-tolerated and considered a safe option for those looking to quit smoking. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for quitting smoking, which often includes medications like bupropion or varenicline, Nicotine Replacement Therapy (NRT) offers a different approach by directly replacing nicotine to ease withdrawal symptoms. Researchers are excited about NRT because it provides smokers with a controlled, low-dose supply of nicotine without the harmful chemicals found in cigarettes, potentially making the quitting process smoother. Additionally, pairing NRT with resources like the West Virginia Quit Line could enhance support, offering a comprehensive approach to help individuals quit smoking more effectively.

What is the effectiveness track record for Nicotine Replacement Therapy in quitting smoking?

Research shows that Nicotine Replacement Therapy (NRT), which participants in this trial may receive, helps people quit smoking. Studies have found that NRT can control cravings and ease withdrawal symptoms. Combining nicotine patches with fast-acting options like gum or lozenges can increase the chances of quitting. One study found that higher doses of nicotine patches slightly improved success rates. Overall, NRT is a proven and common method for those wanting to quit smoking. ^{1 6 7 8 9}

Who Is on the Research Team?

Bradley End

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for individuals who use tobacco and are seeking to quit, particularly those visiting the emergency department. Specific eligibility criteria details were not provided.

Inclusion Criteria

I can do phone or online check-ins when needed.

Reported English speaking

Current daily use cigarettes greater than or equal to ½ pack per day

Exclusion Criteria

Medically unstable patients

WVU students

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 2-week supply of Nicotine Replacement Therapy (NRT) and a West Virginia Quit Line fact sheet/contact information

2 weeks

Follow-up

Participants are monitored for tobacco cessation point abstinence rates at 2 weeks, 1 month, and 3 months post randomization

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Replacement Therapy

Trial Overview The study aims to test if starting Nicotine Replacement Therapy (NRT) in the emergency department helps people quit smoking better than the usual care. Success is measured by whether patients have stopped smoking after 2 weeks, 1 month, and at 3 months post-treatment.

How Is the Trial Designed?

Group I: Control Non NRT Therapy Experimental Treatment 1 Intervention

Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.

Group II: Nicotine Replacement Therapy (NRT) Active Control 2 Interventions

Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.

Nicotine Replacement Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as NRT for:

• Smoking cessation

Approved in European Union as NRT for:

• Smoking cessation

Approved in Canada as NRT for:

• Smoking cessation

Approved in Japan as NRT for:

• Smoking cessation

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493148/

Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf NRTs are designed to replicate the nicotine response typically experienced through smoking, thereby helping individuals manage cravings and withdrawal symptoms.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15266423/

Nicotine replacement therapy for smoking cessation Higher doses of nicotine patch may produce small increases in quit rates. Only one study directly compared NRT to another pharmacotherapy. In this study quit ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1525510/full

Nicotine replacement therapy as a smoking cessation tool ... While NRT can reduce smoking and alleviate withdrawal symptoms, its effectiveness in sustaining long-term cessation in adolescents is limited.

4. publications.ersnet.org publications.ersnet.org/content/erj/40/3/548

Efficacy of a nicotine mouth spray in smoking cessation Unpublished results from a craving relief study demonstrate that two doses of NMS 1 mg reduced craving significantly faster than either nicotine lozenge 2 mg or ...

5. evidence.nihr.ac.uk evidence.nihr.ac.uk/alert/using-both-nicotine-patches-and-gum-together-improves-the-chances-of-quitting-smoking/

Using both nicotine patches and gum together improves ... Using a nicotine patch together with a fast-acting type of nicotine replacement therapy (NRT) such as gum or lozenges improves smoking cessation rates.

6. cancer.org cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html

Nicotine Replacement Therapy to Help You Quit Tobacco Many studies have shown using NRT can almost double the chances of quitting smoking. It hasn't been studied as much for quitting smokeless ...

7. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Adverse-events-associated-with-nicotine-replacement-therapy-NRT-for-smoking-cessation,65973,0,2.html

Adverse events associated with nicotine replacement ... Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence.

8. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-combine-medicines.html

How to Combine Quit Smoking Medicines Using two nicotine replacement medicines (NRTs) together is more likely to help you quit successfully than using one alone. Patch will reduce your withdrawal ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2917405/

Adverse events associated with nicotine replacement therapy ... This review demonstrates that NRT is associated with adverse effects that may be discomforting for the patient but are not life-threatening. Given the long-term ...