What side effects are associated with this type of intervention?

Common treatments for tobacco use include nicotine replacement therapies (NRTs) like patches, gums, and inhalers, which can cause side effects such as skin irritation, mouth soreness, and mild coughing. Pharmacotherapies like varenicline and bupropion are also used; varenicline may cause nausea, insomnia, and vivid dreams, while bupropion can lead to dry mouth, insomnia, and an increased risk of seizures. Very low nicotine content cigarettes, which aim to reduce nicotine exposure, may result in withdrawal symptoms such as irritability, anxiety, and difficulty concentrating as the body adjusts to lower nicotine levels.

What prior FDA approvals exist?

The FDA has approved several treatments for tobacco use, including varenicline, bupropion, and various forms of nicotine replacement therapy (NRT) such as patches, gum, and lozenges. Varenicline and bupropion are non-nicotine medications that help reduce cravings and withdrawal symptoms. NRTs provide a controlled dose of nicotine to ease the transition away from smoking. These treatments are often used in combination with behavioral support for optimal effectiveness. While Very Low Nicotine Content (VLNC) cigarettes are being studied for their potential to reduce nicotine exposure, they are not yet FDA-approved for smoking cessation.

What other types of research exist?

Promising alternatives to Very Low Nicotine Content (VLNC) cigarettes for tobacco use patients include: 1) Combination of behavioral support and pharmacotherapy, such as varenicline or a combination of nicotine replacement therapies (NRTs). 2) Digital interventions, including mobile apps and online support programs. 3) Acceptance and Commitment Therapy (ACT) delivered face-to-face or via telephone. 4) Mindfulness-based interventions and exercise programs. These methods have shown efficacy in smoking cessation and can be tailored to individual patient needs.

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Nicotine Replacement Therapy

Low-Nicotine Cigarettes for Heart Health (CEV Trial)

Phase < 1

Recruiting

Led By Eric C Donny, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hour 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of cigarettes with very low nicotine on smokers' hearts. It includes both daily and occasional smokers. Researchers will compare heart rate and other heart functions when participants smoke low-nicotine and regular cigarettes to see how reducing nicotine impacts heart health.

Who is the study for?

This trial is for adults over 21 who smoke cigarettes at least once a month, can understand English well enough for study procedures, and are willing to smoke either very low nicotine content cigarettes or their usual brand during the lab visit. It's not for those trying to quit smoking, with recent cardiovascular diseases, high body temperature, thyroid disorders, pregnant or breastfeeding women, or unstable health conditions affecting ECG readings.

What is being tested?

The study investigates the cardiovascular effects of 'SPECTRUM' cigarettes which have very low nicotine content compared to smokers' usual brands. Daily and non-daily smokers will participate in lab visits where they'll smoke these research cigarettes to see how they affect heart health.

What are the potential side effects?

While specific side effects aren't listed here as it's an observational study on cardiovascular effects rather than a drug trial, potential risks may include typical smoking-related side effects such as increased heart rate and blood pressure changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 1 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Heart rate - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

Change in Heart rate - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

Secondary study objectives

Change in Heart rate variability(HRV) - Normal Nicotine Content Cigarettes (NNCC)s - NRC600/601(15.8mg nicotine)

Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC102/103(0.5mg nicotine)

Change in Heart rate variability(HRV) - Very Low Nicotine Content Cigarettes (VLNCC)s - NRC301/302(2.4mg nicotine)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Research Cigarettes (SPECTRUM)Experimental Treatment1 Intervention

Participants will smoke 1-2 SPECTRUM cigarettes

Group II: Usual Brand of CigarettesActive Control1 Intervention

Participants will smoke 2-3 cigarettes of their usual brand

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SPECTRUM cigarettes

2017

N/A

~310

Do I qualify?Apply below to find out

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 nicotine replacement therapy (NRT), varenicline, and bupropion. NRT provides controlled nicotine doses to ease withdrawal symptoms and cravings. Varenicline reduces cravings and blocks nicotine's rewarding effects by acting on nicotinic receptors. Bupropion helps reduce withdrawal symptoms by inhibiting norepinephrine and dopamine reuptake. Behavioral interventions, such as counseling, support behavior change and coping strategies. Combining these treatments is often more effective. Very Low Nicotine Content (VLNC) cigarettes reduce nicotine exposure, making smoking less rewarding and aiding in dependence reduction.

The Effectiveness of Nicotine Replacement Therapy in Light Versus Heavier Smokers.[Smoking cessation in pneumological routine care].The natural history of efforts to stop smoking: a prospective cohort study.