What side effects are associated with this type of intervention?

Common treatments for smoking cessation include nicotine replacement therapies (NRTs) like patches, gums, and lozenges, which can cause side effects such as skin irritation, dizziness, and sleep disturbances. Varenicline, another effective cessation aid, is associated with nausea, insomnia, and vivid dreams. Bupropion, an antidepressant also used for smoking cessation, can lead to dry mouth, insomnia, and an increased risk of seizures. While menthol cigarettes are not a cessation treatment, their use has been studied for its impact on smoking behavior and systemic inflammation, but no consistent or significant associations with smoking cessation have been identified.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including varenicline, bupropion, and various forms of nicotine replacement therapies (NRTs) such as nicotine patches, gums, and nasal sprays. Varenicline works by targeting nicotine receptors in the brain to reduce cravings and withdrawal symptoms. Bupropion is an antidepressant that also helps reduce the urge to smoke. NRTs provide a controlled dose of nicotine to ease withdrawal symptoms. These treatments are designed to support individuals in quitting smoking, similar to the goals of the trial studying the impact of menthol flavoring in cigarettes on systemic inflammation.

What other types of research exist?

Promising novel alternatives to menthol flavoring in cigarettes for reducing systemic inflammation include non-mentholated very low nicotine content (VLNC) cigarettes and potentially e-cigarettes with lower toxic compound concentrations. VLNC cigarettes have been shown to reduce nicotine exposure and related biomarkers, which may help in reducing inflammation. Additionally, e-cigarettes, while not completely risk-free, contain fewer toxic compounds compared to traditional cigarettes and may present a lower risk of inflammation. Patients should discuss these options with their healthcare provider to determine the best course of action.

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Switching Cigarette Types for Smoking Inflammation (MINT Trial)

N/A

Recruiting

Led By Nancy C Jao, PhD

Research Sponsored by Rosalind Franklin University of Medicine and Science

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women between 21-60 years old

Be older than 18 years old

Must not have

History of severe medical/psychiatric condition or treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if switching from menthol to non-menthol cigarettes affects inflammation markers in the blood, which are linked to heart disease risk. It targets menthol cigarette smokers to see if this change can improve their health.

Who is the study for?

This trial is for men and women aged 21-60 who smoke at least 5 menthol cigarettes daily for over a year, can use a smartphone with the LifeData app, and speak English fluently. It's not for those pregnant, breastfeeding, trying to quit smoking, heavy drinkers, users of non-menthol tobacco or illicit drugs, or with severe health/psychiatric conditions.

What is being tested?

The study investigates if switching cigarette types affects markers in the blood that signal inflammation linked to heart disease risk. Participants will change their usual menthol cigarettes as part of the research to see how it influences these biomarkers.

What are the potential side effects?

Since this trial involves switching cigarette types rather than medication or medical procedures, traditional side effects are not applicable. However, changes in smoking habits could potentially alter cravings or withdrawal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a severe medical or psychiatric condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cytokine Panel 13

Fibrinogen

high sensitivity C-reactive protein

Secondary study objectives

Blood pressure

Heart rate

Other study objectives

Affect

CO level

Nicotine Dependence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cigarette Type SwitchingExperimental Treatment1 Intervention

Participants will be switched from smoking menthol cigarettes to non-menthol cigarettes

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for smoking cessation include pharmacologic and behavioral interventions. Nicotine replacement therapy (NRT) provides controlled nicotine doses to alleviate withdrawal symptoms and cravings. Bupropion, an antidepressant, reduces the urge to smoke by affecting brain neurotransmitters. Varenicline binds to nicotine receptors, reducing cravings and blocking nicotine's pleasurable effects. Behavioral interventions, such as counseling and motivational interviewing, aim to change smoking behaviors and offer support. Combining these treatments is often more effective than using either alone. Understanding these mechanisms helps tailor treatment plans to individual needs, increasing the chances of successful smoking cessation.

[Cigarette smoking. A pilot project of dehabituation and experimental research].Assessing the evidence on the differential impact of menthol versus non-menthol cigarette use on smoking cessation in the U.S. population: a systematic review and meta-analysis.Nicotine Replacement Therapy: An Overview.