Nicotine Replacement Therapy for Smoking Cessation

Recruiting at 1 trial location

Overseen By Larry W Hawk, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: State University of New York at Buffalo

Must be taking: Dual NRT

Must not be taking: Smoking cessation, Antipsychotics

Disqualifiers: Pregnancy, Cardiovascular events, Alcohol dependence, 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: 7

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a combination of nicotine replacement therapies, such as patches and lozenges, can aid smoking cessation. Researchers aim to determine whether remote or in-person treatment sessions prove more effective. Individuals who smoke more than five cigarettes a day and are motivated to quit may be suitable candidates. Participants will be randomly assigned to either remote or in-person sessions and monitored for three months to evaluate treatment effectiveness. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

If you are currently using any smoking cessation or antipsychotic medications, you will need to stop taking them to participate in this trial.

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

Research has shown that a combination of nicotine replacement therapies (NRT) is generally safe for those trying to quit smoking. Studies have found that nicotine patches can double the chances of quitting after four weeks without causing serious side effects. One study found that using different forms of NRT together, such as patches and gum, helps more people quit compared to using just one type.

Overall, combination NRT is well-tolerated, meaning most people can use it without major problems. If side effects occur, they are usually mild, such as skin irritation from patches or a sore throat from lozenges. This treatment has been tested in many studies, providing strong evidence of its safety in helping people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different approaches to nicotine replacement therapy (NRT) for smoking cessation, focusing on how treatment and assessment are delivered. Unlike traditional methods that often require in-person visits, this trial examines both remote and in-person combinations, potentially making it more convenient and accessible. By comparing these various delivery methods, researchers hope to find out which approach is most effective, providing valuable insights that could enhance the success rates of quitting smoking. This trial could lead to more personalized and flexible treatment options for people looking to quit smoking, addressing barriers such as travel and scheduling difficulties.

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

Research has shown that combining nicotine replacement therapies (NRT) is more effective than using a single type. For example, one study found that adding a fast-acting NRT, such as gum or lozenges, to a nicotine patch increased quit rates by 5%. Another study demonstrated that using a combination of NRTs resulted in higher quit rates after 6 to 12 months compared to using just one type—17.4% versus 13.9%. A review of multiple studies confirmed that combination therapy is more effective at helping people quit smoking at 3, 6, and 12 months. This trial will evaluate the effectiveness of combination NRT in various settings, including remote and in-person treatment and assessment visits. These findings suggest that using different types of nicotine replacements together can help more people successfully quit smoking. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who want to quit smoking and are willing to try nicotine replacement therapy. Participants must pass a basic eligibility screen and can attend either remote or in-person sessions. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am older than 18 years.

Stable mailing address within accessible range of each study site

I can read, speak, and understand English well.

Exclusion Criteria

Use of tobacco/nicotine products other than cigarettes more than once per week (specific to RCT 1)

Past-year suicide attempt (specific to RCT 1)

Prior allergy/intolerance to NRT patch or lozenge (specific to RCT 1)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

1 visit (remote or in-person)

Intake

Detailed consent and eligibility assessment completed; participants randomized to treatment groups

1 month

1 visit (remote or in-person)

Treatment

Participants receive treatment and assessment visits; adherence and retention monitored

8 weeks

5 visits (remote or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Combination Nicotine Replacement Therapy

Trial Overview The RISE Above Smoking trial is testing the effectiveness of combination nicotine replacement therapy (patches and lozenges) through two settings: remotely or in-person. Participants will be randomly assigned to one of these groups after an initial screening, with follow-ups over three months.

How Is the Trial Designed?

Group I: REMOTE intake BUT IN-PERSON treatment/assessment Experimental Treatment 1 Intervention

In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.

Group II: REMOTE intake AND REMOTE treatment/assessment Experimental Treatment 1 Intervention

In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.

Group III: IN-PERSON intake, BUT REMOTE treatment/assessment Experimental Treatment 1 Intervention

In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.

Group IV: IN-PERSON intake AND IN-PERSON treatment/assessment Experimental Treatment 1 Intervention

In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Abramson Cancer Center at Penn Medicine

Collaborator

Trials

425

Recruited

464,000+

Published Research Related to This Trial

In a study of 400 smokers, using a nicotine inhaler combined with a nicotine patch led to significantly higher smoking cessation rates compared to using the inhaler with a placebo patch, with 60.5% abstinence at 6 weeks versus 47.5%.

The combination therapy not only improved cessation rates but also showed a trend toward better lung function and reduced respiratory symptoms in those who quit smoking, indicating its potential benefits for overall respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Bohadana, A., Nilsson, F., Rasmussen, T., et al.[2019]

Combining different nicotine replacement therapies (NRT), such as a transdermal patch for slow nicotine delivery and gum for on-demand relief, may enhance the effectiveness of smoking cessation efforts, potentially providing better withdrawal relief than using a single therapy alone.

While some studies suggest that combination NRT can be more effective than monotherapy for certain individuals, the evidence is not yet strong enough to draw definitive conclusions, indicating a need for further research to fully understand its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability. Sweeney, CT., Fant, RV., Fagerstrom, KO., et al.[2018]

In a study of 84,667 patients in a smoking cessation program, it was found that the prescribed doses of nicotine replacement therapy (NRT) did not increase adequately with the number of cigarettes smoked per day, leading to potential under-treatment.

Patients who received initial NRT doses below 2 mg per cigarette per day had poorer cessation outcomes, suggesting that higher doses may be necessary for heavy smokers to improve their chances of quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. Veldhuizen, S., Behal, A., Zawertailo, L., et al.[2023]

A study of 366 quit attempters using nicotine replacement therapy (NRT) found that many users discontinue treatment prematurely, primarily due to resuming smoking (34%) and experiencing side effects (17%).

Factors such as poverty, age, and minority status were linked to higher rates of discontinuation, suggesting that tailored interventions could improve compliance and enhance the effectiveness of NRT in helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation of nicotine replacement therapy among smoking-cessation attempters. Burns, EK., Levinson, AH.[2022]

Nicotine replacement therapy (NRT) is safe and effective, but it is often used incorrectly; providing clear instructions and adequate dosing is crucial for maximizing its benefits.

Combining different forms of NRT, such as using a nicotine patch with gum or lozenges, and starting the patch two weeks before quitting can significantly improve quit rates and help prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising nicotine replacement therapy in clinical practice. Mendelsohn, C.[2018]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

In a review of 28 clinical trials involving 7,120 participants, only 10.5% experienced a significant increase in cotinine levels (>50% above baseline) while using nicotine replacement therapy (NRT), indicating that high nicotine exposure is relatively uncommon.

Adverse events related to nicotine overdose, such as nausea, vomiting, and palpitations, were reported infrequently (0.2% to 0.5% of subjects), supporting the overall safety of NRT for smoking cessation or reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. Tonstad, S., Gustavsson, G., Kruse, E., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central One study within their review disclosed that augmenting a nicotine patch with fast-acting NRT resulted in a 5% increase in abstinence rates when ...

2. journals.lww.com journals.lww.com/ebp/fulltext/2023/05000/is_combination_nicotine_replacement_therapy_more.21.aspx

Is combination nicotine replacement therapy more effective... Combination NRT resulted in significantly higher quit rates at 6 to 12 months than single-form NRT (14 RCTs, N=11,356; 17.4% vs 13.9%; risk ratio [RR] 1.25; 95% ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817927

Enhanced vs Standard Varenicline Treatment for Tobacco ... Tobacco cessation at 52 weeks was 25.1% (79 of 315) for 12-week monotherapy, 24.4% (76 of 311) for 24-week monotherapy, 23.6% (74 of 314) for 12 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1544319115311389

Systematic review and meta-analysis of combination ... Meta-analysis revealed that combination therapy for smoking cessation treatment is significantly better than monotherapy at 3, 6, and 12 months. Statistically, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02148445

Smoking Cessation Versus Long-term Nicotine ... The purpose of this study is to see if guided maintenance therapy (GMT), using long-term NRT, might prove to be a reasonable alternative to the standard ...

6. ncsct.co.uk ncsct.co.uk/library/view/pdf/combination-NRT-2024-25-v1.pdf

combination NRT 2024-25 v1 9,10. The SNAP study found the NRT patch doubled four-week quit rates and did not result in adverse pregnancy outcomes or children at two-year follow-up.10 ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70235?af=R

Efficacy of combined varenicline and nicotine replacement ... Low-certainty evidence indicates that combining varenicline with nicotine replacement therapy may improve long-term smoking cessation rates ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293179/

Comparative clinical effectiveness and safety of tobacco ... Most tobacco cessation monotherapies and combination therapies are more effective than placebo at helping participants to achieve sustained abstinence.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820435

Varenicline and Nicotine Replacement Therapy for ... If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the ...