Nicotine Replacement Therapy for Smoking

(DEDUCE Trial)

Overseen By Francis J. McClernon, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must be taking: Nicotine replacement

Disqualifiers: Pregnancy, Smoking cessation treatment, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people quit smoking by using transdermal nicotine replacement therapy (nicotine patches) while examining the environments where they smoke. Researchers seek to understand how different surroundings might trigger cravings and lead to relapse. Participants will take photos of their environments to provide insights through artificial intelligence. This study targets adults who have smoked at least 10 cigarettes daily for over two years and wish to quit within the next month, using a smartphone to participate. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants a chance to contribute to research that helps understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently using smoking cessation products, you would not be eligible to participate.

What is the safety track record for transdermal nicotine replacement therapy?

Research has shown that nicotine replacement therapy (NRT), such as the nicotine patch, is generally safe. Studies have found that while NRT can cause some uncomfortable side effects, they are not dangerous. For example, skin irritation at the patch site or mild nausea may occur, but these issues are usually manageable.

Importantly, even for individuals with heart conditions, research has found no significant increase in heart problems when using NRT. This indicates that the therapy is well-tolerated, even for those at higher risk due to existing health issues.

Overall, NRT is widely used and has a strong safety record, making it a reliable choice for those looking to quit smoking. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Transdermal Nicotine Replacement Therapy is unique because it delivers nicotine through the skin, providing a steady release to help manage cravings and withdrawal symptoms for smokers trying to quit. Unlike traditional nicotine replacement methods like gums or lozenges, which require frequent dosing, the patch offers a more convenient and consistent delivery of nicotine throughout the day. Researchers are excited about this approach because it can lead to higher adherence and potentially better outcomes for those looking to kick the habit.

What is the effectiveness track record for transdermal nicotine replacement therapy in smoking cessation?

Research has shown that nicotine patches, a type of transdermal nicotine replacement therapy (NRT), can help people quit smoking. Studies have found that nicotine patches can double the chances of quitting compared to a placebo. Long-term use of nicotine gum, patches, or lozenges significantly increases the likelihood of quitting. On average, NRT raises successful quit rates from 10% to 17%. Combining nicotine patches with fast-acting nicotine products further improves quit rates compared to using patches alone. This treatment has proven effective in helping people stop smoking and is widely recommended for those trying to quit. Participants in this trial will receive transdermal nicotine replacement therapy to evaluate its effectiveness in smoking cessation. ^{6 7 8 9 10}

Who Is on the Research Team?

Francis J. McClernon, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults who smoke and want to quit. They'll be part of a study using digital tools like sensors and AI to understand how their environment affects smoking habits. Participants will take pictures of where they smoke before trying to quit with the help of nicotine patches.

Inclusion Criteria

Have an iPhone or Android smartphone capable of running the photoEMA and iCO software

I plan to quit smoking within the next month.

I smoke 10 or more cigarettes daily.

Exclusion Criteria

Pregnant, breastfeeding, or planning to become pregnant during the course of the study

I am currently trying to quit smoking or using products to help me stop.

Regular use (i.e. >9 days/month) of non-cigarette nicotine-containing products (e.g. cigarillos, e-cigarettes)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-quit Monitoring

Participants undergo photoEMA, taking pictures of their environment when they smoke and randomly 10 times per day

2 weeks

Treatment

Participants receive transdermal nicotine replacement therapy to support smoking cessation

6 months

Follow-up

Participants are monitored for smoking relapse and abstinence

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transdermal Nicotine Replacement Therapy

Trial Overview The study tests if 'digital envirotyping' can predict relapse in smokers trying to quit. It involves taking photos of environments related to smoking, supported by transdermal nicotine replacement therapy (nicotine patches) as a quitting aid.

How Is the Trial Designed?

Group I: study group Experimental Treatment 1 Intervention

All participants will receive transdermal nicotine replacement therapy.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4410859/

Long-term Nicotine Replacement Therapy Joseph and colleagues found that extended treatment with nicotine gum, patches, or lozenges for 52 weeks significantly increased smoking cessation rates ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1326020023015248

Ten‐year survival outcome of the nicotine transdermal ... It has been shown to produce more than double 12‐month sustained abstinence after quitting compared with placebo.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01622998

Self-directed Titrated Transdermal Nicotine Patch Versus ... The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37335995/

Different doses, durations and modes of delivery of nicotine ... There is high-certainty evidence that combination NRT (fast-acting form plus patch) results in higher long-term quit rates than single form ( ...

5. thennt.com thennt.com/nnt/nicotine-replacement-therapy-for-smoking-cessation/

Nicotine Replacement Therapy for Smoking Cessation Overall, NRT increased successful cessation rates from 10 to 17%, with a number needed to treat (NNT) of 15.

6. 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 ...

7. nejm.org nejm.org/doi/full/10.1056/NEJM199612123352402

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.

8. fda.gov fda.gov/media/167599/download

Developing Nicotine Replacement Therapy Drug Products other smoking cessation drugs and any non-study nicotine or tobacco products should be recorded. At a minimum, exhaled breath carbon monoxide (CO) should be ...

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.118.009424

Short‐Term Safety of Nicotine Replacement in Smokers ... Among smokers hospitalized for treatment of coronary heart disease, use of NRT was not associated with any differences in short‐term outcomes.

10. sciencedirect.com sciencedirect.com/science/article/pii/S073510979700079X

Cardiovascular Toxicity of Nicotine: Implications for ... Clinical trials of NRT in patients with underlying, stable coronary disease suggest that nicotine does not increase cardiovascular risk.