200 Participants Needed

Nicotine Replacement Therapy for Smoking Cessation

Recruiting at 1 trial location
LW
Overseen ByLarry 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
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

Trial Summary

What is the purpose of this trial?

The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.

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.

What data supports the effectiveness of the treatment Combination Nicotine Replacement Therapy for smoking cessation?

Research shows that using a combination of nicotine replacement therapies, like a patch and an inhaler, can be more effective for quitting smoking than using just one type. This approach helps manage cravings and withdrawal symptoms better by providing both steady and quick relief.12345

Is nicotine replacement therapy generally safe for humans?

Nicotine replacement therapy (NRT) is considered effective and safe for helping people quit smoking, although some users may experience high nicotine levels leading to mild symptoms of nicotine toxicity.14678

How is combination nicotine replacement therapy different from other smoking cessation treatments?

Combination nicotine replacement therapy is unique because it uses two forms of nicotine delivery: a patch for steady, slow release and an inhaler for quick relief of cravings. This dual approach can be more effective than using just one method, as it addresses both constant and sudden urges to smoke.125910

Eligibility Criteria

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.
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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)
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Timeline

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

Treatment Details

Interventions

  • Combination Nicotine Replacement Therapy
Trial OverviewThe 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.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: REMOTE intake BUT IN-PERSON treatment/assessmentExperimental Treatment1 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/assessmentExperimental Treatment1 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/assessmentExperimental Treatment1 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/assessmentExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability.Sweeney, CT., Fant, RV., Fagerstrom, KO., et al.[2018]
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.
Discontinuation of nicotine replacement therapy among smoking-cessation attempters.Burns, EK., Levinson, AH.[2022]

References

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]
Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability. [2018]
Discontinuation of nicotine replacement therapy among smoking-cessation attempters. [2022]
Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. [2018]
Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. [2023]
Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]
Optimising nicotine replacement therapy in clinical practice. [2018]
Combination therapy of varenicline with nicotine replacement therapy is better than varenicline alone: a systematic review and meta-analysis of randomized controlled trials. [2023]
Pharmacotherapy in smoking cessation. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
The nicotine inhaler in smoking cessation. [2021]