What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) include lifestyle changes, medications, and surgical interventions. Medications such as statins, beta-blockers, and antiplatelet agents can cause side effects like muscle pain, fatigue, and increased bleeding risk, respectively. Nicotine Replacement Therapy (NRT), used to aid smoking cessation, can cause side effects such as nausea, dizziness, and irritation at the application site (e.g., skin patches). When NRT is guided by genetic profiling, it may improve efficacy but does not significantly alter the side effect profile.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of Coronary Artery Disease (CAD), including Nicotine Replacement Therapy (NRT) products such as nicotine patches, gum, and lozenges. These NRT products are designed to provide controlled doses of nicotine to help reduce withdrawal symptoms and cravings, which can be particularly beneficial for CAD patients who smoke. Additionally, medications like varenicline and bupropion have been approved to aid smoking cessation, which is crucial for managing CAD. Emerging research suggests that tailoring NRT based on genetic profiles may further enhance its effectiveness, although this approach is still under investigation.

What other types of research exist?

Promising novel alternatives to Nicotine Replacement Therapy (NRT) for Coronary Artery Disease (CAD) patients include: 1) Bupropion and Varenicline, which are non-nicotine pharmacotherapies that have shown effectiveness in smoking cessation, particularly in patients with cardiovascular conditions. 2) Mobile phone-based interventions and smartphone applications, which provide real-time monitoring, notifications, and support for smoking cessation. 3) Motivational interviewing and Acceptance and Commitment Therapy (ACT), which are behavioral therapies that can be delivered face-to-face or via telephone to support smoking cessation. 4) Electronic cigarettes (e-cigarettes), which have been found to be effective in some randomized controlled trials for smoking reduction and cessation.

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Genotype-Guided Smoking Cessation Therapy for Coronary Artery Disease

N/A

Waitlist Available

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Adult presenting to Barnes hospital cardiac catheterization laboratory with coronary artery disease or admitted to Barnes hospital within 24 hours of a type 1 myocardial infarction (heart attack)

Be older than 18 years old

Must not have

Unable to provide informed consent

Unable to answer questions (e.g. intubated)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after enrollment

Awards & highlights

Summary

This trial tests if using genetic information to guide smoking cessation treatment can help patients with coronary artery disease quit smoking more effectively. Patients will receive either nicotine replacement therapy or counseling based on their genetic test results.

Who is the study for?

This trial is for adults with coronary artery disease undergoing cardiac catheterization or who have had a heart attack, and are active smokers. They must be able to consent, not incarcerated, stable post-heart attack without life-threatening complications, and women of child-bearing age should not be pregnant or breastfeeding.

What is being tested?

The study tests if nicotine patches and genotype-guided therapy can help patients quit smoking more effectively than standard treatments. Patients' genetic profiles determine their treatment plan in this randomized study.

What are the potential side effects?

Nicotine patch use may cause skin irritation, dizziness, racing heartbeat, sleep problems or unusual dreams. Counseling has no physical side effects but discussing smoking cessation can sometimes cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I was admitted to Barnes hospital for a heart attack or have coronary artery disease.

Exclusion Criteria

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

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I am unable to understand and give consent for treatment.

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I am currently unable to communicate verbally.

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I am pregnant or breastfeeding.

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I have had serious complications from a heart attack.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after enrollment for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Smoking Cessation

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Genotype-guided (GG homozygotes)Experimental Treatment2 Interventions

CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (GG homozygotes will be given smoking cessation counseling)

Group II: Genotype-guided (A allele carriers)Experimental Treatment2 Interventions

CHRNA5 rs16969968 genotype will be determined. Genotype-guided therapy will be given (A allele carriers will be given pharmacologic therapy (nicotine replacement therapy --NRT; nicotine patch used according to FDA labelling).)

Group III: Standard (non-genotype guided) - NRTActive Control1 Intervention

1/2 of patients in this arm will be given nicotine replacement therapy (NRT; nicotine patch used according to FDA labeling) but this will NOT be based on the patient's genotype. Note that both nicotine replacement therapy and counseling are accepted treatments for smoking cessation in patients with coronary artery disease.

Group IV: Standard (non-genotype guided)- counselingActive Control1 Intervention

1/2 of patients in this arm will be given smoking cessation counseling but this will NOT be based on the patient's genotype. Note that both nicotine replacement therapy and counseling are accepted treatments for smoking cessation in patients with coronary artery disease.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine patch

2015

Completed Phase 4

~6130

Smoking cessation counseling

2011

Completed Phase 4

~10150

0 / 5Eligibility 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

Nicotine Replacement Therapy (NRT) works by delivering nicotine to the body without the harmful chemicals found in tobacco smoke, thereby reducing withdrawal symptoms and cravings. This is crucial for Coronary Artery Disease (CAD) patients because smoking is a significant risk factor for CAD, and quitting smoking can lead to substantial improvements in cardiovascular health. Moreover, tailoring NRT based on a patient's genetic profile can enhance its effectiveness, leading to higher quit rates and better overall management of CAD.

Pharmacological Smoking Cessation Therapies in Older Adults: A Review of the Evidence.