Genotype-Guided Smoking Cessation Therapy for Coronary Artery Disease

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

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

You are already taking part in the PRISM-GENOMICS observational study.

You are currently smoking when you come to Barnes Hospital.

Exclusion Criteria

I have had serious complications from a heart attack.

I am unable to understand and give consent for treatment.

I am currently unable to communicate verbally.

Treatment Details

Interventions

• genotype-guided therapy (Other)
• Nicotine patch (Nicotine Replacement Therapy)
• Smoking cessation counseling (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Genotype-guided (GG homozygotes) Experimental Treatment 2 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 Treatment 2 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) - NRT Active Control 1 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)- counseling Active Control 1 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+