308 Participants Needed

Nicotine Regulation for Tobacco Use Disorder

(RDEC Trial)

Recruiting at 1 trial location
EB
JT
Overseen ByJennifer Tidey, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Vermont
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
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, completely switching from cigarettes to e-cigarettes likely reduces risk for tobacco-related harm. However, many established dual users maintain long-term smoking and the majority who use e-cigarettes non-daily are at an even greater risk for prolonged smoking than exclusive cigarette smokers. The Food and Drug Administration Center for Tobacco Products (FDA CTP) has announced plans to implement a nicotine-limiting product standard, capping the nicotine in cigarettes at a minimally or non-addictive level. Randomized controlled trials (RCTs) demonstrate that adults who exclusively smoke cigarettes respond to very low nicotine content (VLNC) cigarettes with reductions in smoking, demand, and dependence. However, nicotine reduction RCTs to date have excluded people who regularly use e-cigarettes and therefore it remains unclear how a nicotine-limiting standard for cigarettes would affect smoking among dual users. Given the potential substitutability of e-cigarettes for cigarettes, reducing the nicotine in cigarettes could promote a transition to exclusive e-cigarette use among dual users unable to completely quit nicotine, but only if sufficiently appealing e-cigarettes remain available. E-cigarettes containing 5% nicotine-salt solution are currently most popular in the US, but policy makers have proposed restricting e-cigarettes to ≤ 2% nicotine to curb youth e-cigarette use, and several states have already set limits to reduce nicotine in e-cigarettes. Prior laboratory studies indicate that higher vs lower nicotine e-cigarettes serve as better substitutes for cigarettes among adult dual users. As such, a restriction on e-cigarette nicotine concentration could undermine the potential for e-cigarettes to substitute for cigarettes and diminish the benefits of a nicotine-limiting standard for cigarettes among dual users. This study is a 12-week double-blind 2 cigarette level (Normal Nicotine vs Very Low Nicotine) x 2 e-cigarette level (High Nicotine vs Low Nicotine) between-subjects factorial trial to investigate how a nicotine-limiting standard for cigarettes affects adult dual users and whether these effects are impacted by constraints on e-cigarette nicotine concentration. Outcome measures include cigarettes per day, cigarette dependence, and toxicant exposure. The research is highly relevant to FDA CTP domains of Addiction and Behavior because it will test whether reducing the nicotine content of cigarettes reduces smoking and dependence, and whether these effects are moderated by the availability of high vs low nicotine e-cigarettes.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Nicotine Regulation for Tobacco Use Disorder?

Research shows that Nicotine Replacement Therapy (NRT), which is part of Nicotine Regulation, helps people quit smoking by reducing the number of cigarettes smoked and increasing motivation to quit. Studies also indicate that using NRT during hospital stays can be a good opportunity to encourage quitting.12345

Is nicotine replacement therapy generally safe for humans?

Nicotine replacement therapy (NRT) is generally considered safe for humans, although some people may experience side effects, especially if nicotine levels become too high. Studies have shown that while NRT is effective in helping people quit smoking, monitoring for potential neuropsychiatric and cardiovascular risks is important.678910

How is Nicotine Regulation different from other treatments for tobacco use disorder?

Nicotine Regulation, also known as Nicotine Replacement Therapy, is unique because it involves using various forms of nicotine delivery, like patches, gum, or sprays, to gradually reduce dependence on tobacco. Unlike other treatments, it focuses on managing nicotine levels to reduce addiction without the harmful effects of smoking.311121314

Research Team

EK

Elias Klemperer, PhD

Principal Investigator

University of Vermont

Eligibility Criteria

This trial is for adult smokers who regularly use both e-cigarettes and traditional cigarettes. Participants should be dual users to understand how varying nicotine levels in these products impact their smoking habits and dependence.

Inclusion Criteria

Regular use of tobacco
Speak, comprehend, and read English well enough to complete study procedures
I am 21 years old or older.

Exclusion Criteria

Pregnant, trying to become pregnant, or nursing
Health conditions that could undermine ability to complete the study
I am younger than 21 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of four groups to receive either normal or very low nicotine cigarettes and high or low nicotine e-cigarettes for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of cigarettes per day, cigarette dependence, and toxicant exposure

4 weeks

Treatment Details

Interventions

  • Nicotine Regulation
Trial Overview The study tests the effects of changing nicotine content in cigarettes and e-cigarettes on smoking behavior. It's a double-blind trial with four groups: normal/high nicotine, normal/low, very low/high, and very low/low combinations.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: RC 2 + REC 2Experimental Treatment2 Interventions
Research cigarettes #2 + research e-cigarettes #2
Group II: RC 2 + REC 1Experimental Treatment2 Interventions
Research cigarettes #2 plus research cigarettes #1
Group III: RC 1 + REC 2Experimental Treatment2 Interventions
Research cigarettes #1 plus research e-cigarettes #2
Group IV: RC 1 + REC 1Experimental Treatment2 Interventions
Research cigarettes #1 plus research e-cigarettes #1

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

🇪🇺
Approved in European Union as Nicotine Replacement Therapy for:
  • Smoking cessation
  • Nicotine addiction
🇺🇸
Approved in United States as Nicotine Limitation for:
  • Smoking cessation
  • Tobacco-related harm reduction
🇨🇦
Approved in Canada as Nicotine Regulation Standard for:
  • Smoking cessation
  • Nicotine addiction management

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials
283
Recruited
3,747,000+

Findings from Research

The 'Reduce to Stop' method of Nicotine Replacement Therapy (NRT) helps smokers gradually decrease their cigarette intake while using nicotine preparations, making it a promising option for those not ready to quit completely.
Clinical research shows that this approach not only effectively reduces smoking but also boosts motivation to quit, leading to higher chances of completely giving up smoking.
[Alternative method of smoking cessation--reduce to stop].Florek, E., Piekoszewski, W.[2015]
In a study of 4,072 current smokers, hospitalization increased the likelihood of receiving a prescription for Nicotine Replacement Therapy (NRT), with an odds ratio of 1.68, indicating a significant association.
Despite this association, only 5% of smokers received an NRT prescription during their hospitalization or at discharge, highlighting a missed opportunity for healthcare providers to promote smoking cessation during hospital stays.
Is hospitalization a missed opportunity to intervene on tobacco cessation?Nielsen, EM., Zhang, J., Marsden, J., et al.[2023]
In a study of 100 smokers, the new nicotine mouth spray was preferred by 54 participants over nicotine gum and inhalers, indicating a strong preference for this delivery method.
While the mouth spray showed comparable efficacy in helping smokers quit, it was associated with a higher rate of local adverse effects, suggesting that reducing the dose might improve safety and compliance.
A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy.Bolliger, CT., van Biljon, X., Axelsson, A.[2015]

References

[Alternative method of smoking cessation--reduce to stop]. [2015]
Is hospitalization a missed opportunity to intervene on tobacco cessation? [2023]
A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy. [2015]
Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]
Discontinuation of nicotine replacement therapy among smoking-cessation attempters. [2022]
Optimising nicotine replacement therapy in clinical practice. [2018]
High-dose transdermal nicotine replacement for tobacco cessation. [2019]
Risk of neuropsychiatric and cardiovascular adverse events following treatment with varenicline and nicotine replacement therapy in the UK Clinical Practice Research Datalink: a case-cross-over study. [2022]
Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. [2018]
Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]
Addressing regulatory barriers to licensing nicotine products for smoking reduction. [2019]
A comparison of the abuse liability and dependence potential of nicotine patch, gum, spray and inhaler. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Smoking cessation. Techniques and benefits. [2019]
Nicotine reduction: strategic research plan. [2021]
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