What is the mechanism of action of this treatment?

Common treatments for tobacco use include pharmacological and behavioral interventions. Nicotine replacement therapy (NRT) works by providing a controlled dose of nicotine to reduce withdrawal symptoms and cravings, helping patients gradually wean off tobacco. Varenicline acts on nicotine receptors in the brain to reduce cravings and withdrawal symptoms while also blocking the pleasurable effects of nicotine. Bupropion is an antidepressant that also reduces cravings and withdrawal symptoms. Behavioral interventions, such as counseling and support groups, help patients develop coping strategies and provide emotional support. IQOS, a newer alternative, heats tobacco to release nicotine-containing vapor without combustion, potentially reducing exposure to harmful chemicals found in cigarette smoke. These treatments are crucial for tobacco use patients as they address both the physical addiction to nicotine and the behavioral aspects of smoking, increasing the likelihood of successful cessation.

What side effects are associated with this type of intervention?

Common treatments for tobacco use include nicotine replacement therapy (NRT), bupropion, and varenicline. NRT, which includes products like patches, gum, and lozenges, can cause side effects such as skin irritation, mouth soreness, and nausea. Bupropion, an antidepressant used for smoking cessation, may lead to insomnia, dry mouth, and an increased risk of seizures. Varenicline, a medication that reduces cravings and withdrawal symptoms, can cause nausea, vivid dreams, and mood changes. For products like IQOS that heat tobacco without combustion, potential side effects include throat irritation, cough, and respiratory issues, although long-term effects are still being studied.

What other types of research exist?

Promising alternatives to IQOS for tobacco use patients in 2024 include: 1) Electronic cigarettes (e-cigarettes) which provide nicotine without combustion, 2) Nicotine Replacement Therapy (NRT) such as patches, gums, and lozenges, 3) Prescription medications like varenicline and bupropion, and 4) Behavioral interventions including mindfulness-based stress reduction and cognitive-behavioral therapy. Combining these methods with support programs can enhance quit rates.

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IQOS Use for Smoking Cessation (IQOS Trial)

Q: What prior FDA approvals exist?

The FDA has approved several treatments for tobacco use, including nicotine replacement therapies (NRT) such as patches, gums, and lozenges, as well as prescription medications like varenicline and bupropion. These treatments aim to reduce withdrawal symptoms and cravings. While IQOS, a device that heats tobacco to release nicotine-containing vapor without combustion, has been authorized for sale in the U.S. by the FDA, it is not classified as a cessation product but rather as a reduced-risk alternative to traditional cigarettes. The FDA's authorization of IQOS is based on its potential to reduce exposure to harmful chemicals compared to combustible cigarettes.

Phase < 1

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Willing to use study provided IQOS devices and HeatSticks during 2 laboratory visits and throughout study participation

Male and female smokers between 18 and 65 years of age who self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months

Must not have

Women who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if 100 cigarette smokers can switch to using IQOS, a device that heats tobacco instead of burning it. By heating the tobacco, IQOS produces fewer harmful chemicals, potentially making it a safer alternative. IQOS is a heated tobacco product developed by Philip Morris International, designed to produce fewer harmful chemicals by heating rather than burning tobacco.

Who is the study for?

This trial is for English-speaking smokers aged 18-65 who smoke at least 5 cigarettes daily for the past year, are not trying to quit in the next month but are interested within six months. They must live locally and agree to use IQOS instead of cigarettes during the study. Pregnant women, heavy drinkers, those with serious diseases or mental health issues like major depression or schizophrenia, substance abuse history, or using other nicotine products aren't eligible.

What is being tested?

The study tests if switching from regular cigarettes to an IQOS device affects smoking behavior over two weeks among 100 participants. It measures how often they smoke before and after getting IQOS and looks into what factors predict whether someone fully switches to this alternative.

What are the potential side effects?

While specific side effects of IQOS use compared to traditional cigarette smoking aren't detailed here, generally users might experience throat irritation or coughing as common reactions when transitioning from conventional smoking methods.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am willing to use the provided IQOS devices and HeatSticks for the study.

Select...

I am between 18 and 65 years old and have smoked at least 5 cigarettes daily for the past year.

Exclusion Criteria

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

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cigarette consumption

Secondary study objectives

Motivation for smoking cessation

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: IQOSExperimental Treatment1 Intervention

0 / 3Eligibility 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 tobacco use include pharmacological and behavioral interventions. Nicotine replacement therapy (NRT) works by providing a controlled dose of nicotine to reduce withdrawal symptoms and cravings, helping patients gradually wean off tobacco. Varenicline acts on nicotine receptors in the brain to reduce cravings and withdrawal symptoms while also blocking the pleasurable effects of nicotine. Bupropion is an antidepressant that also reduces cravings and withdrawal symptoms. Behavioral interventions, such as counseling and support groups, help patients develop coping strategies and provide emotional support. IQOS, a newer alternative, heats tobacco to release nicotine-containing vapor without combustion, potentially reducing exposure to harmful chemicals found in cigarette smoke. These treatments are crucial for tobacco use patients as they address both the physical addiction to nicotine and the behavioral aspects of smoking, increasing the likelihood of successful cessation.

SMOKING CESSATION TREATMENTS: CURRENT PSYCHOLOGICAL AND PHARMACOLOGICAL OPTIONS.Anamnestic findings from patients with recurrent aphthous stomatitis.Tailoring nicotine replacement therapy: rationale and potential approaches.