Integrated Treatment for Smoking Cessation After Acute Coronary Syndrome

Overseen By Andrew Busch, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hennepin Healthcare Research Institute

Disqualifiers: Severe mental illness, Suicidality, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

233 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Summary of the Project : Quitting smoking following acute coronary syndrome (ACS) can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). Objective: For this R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you are not currently attending counseling for depression or smoking cessation.

Is the integrated treatment for smoking cessation after acute coronary syndrome safe?

The safety of smoking cessation treatments, including varenicline, has been studied, but there is limited data specifically for patients with acute coronary syndrome. Some smoking cessation medications can have side effects, so it's important to discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

What makes the BAT-CS treatment unique for smoking cessation after acute coronary syndrome?

BAT-CS is unique because it combines standard smoking cessation counseling with behavioral activation, which helps manage mood and depression, addressing both smoking and mood issues together rather than separately. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment BAT-CS for smoking cessation after acute coronary syndrome?

Research shows that combining smoking cessation counseling with mood management, like in the BAT-CS treatment, can help people quit smoking after a heart event. Behavioral interventions have been found to improve smoking abstinence rates at 6 and 12 months, although more research is needed to confirm these findings. ^{2 3 7 9 10}

Who Is on the Research Team?

Andrew Busch, PhD

Principal Investigator

Senior Investigator

Are You a Good Fit for This Trial?

This trial is for hospital inpatients aged 18-75 who had an acute coronary syndrome (ACS) event within the last month, smoke at least one cigarette daily before hospitalization, speak English, are considering quitting smoking after discharge, and can use a phone. It's not for those with severe mental illness or high risk of dying within six months.

Inclusion Criteria

Willing to consent to all study procedures

I am open to quitting smoking after leaving the hospital.

I have access to a phone or am willing to use one provided by the study.

Exclusion Criteria

I am currently in counseling for depression or to quit smoking.

You are not expected to live for more than 6 months, based on a risk calculator.

I have some difficulties making decisions due to my mental health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) or control condition for 12 weeks, focusing on smoking cessation and mood management

12 weeks

Weekly sessions

Follow-up

Participants are monitored for smoking abstinence, depression symptoms, and major adverse cardiac events

12 months

Assessments at 6, 9, and 12 months post-discharge

Long-term follow-up

Tracking of major adverse cardiac events and all-cause mortality

60 months

What Are the Treatments Tested in This Trial?

Interventions

• BAT-CS
• Smoking Cessation and Health & Wellness

Trial Overview The PACES study tests BAT-CS, an integrated treatment targeting both depression and smoking cessation post-ACS. The goal is to see if this combined approach can effectively reduce mortality by addressing mood issues that may hinder quitting smoking.

How Is the Trial Designed?

Group I: BAT-CS Experimental Treatment 1 Intervention

Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.

Group II: Smoking Cessation and Health & Wellness Active Control 1 Intervention

Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.

Who Is Running the Clinical Trial?

Hennepin Healthcare Research Institute

Lead Sponsor

Trials

94

Recruited

77,100+

Minneapolis Heart Institute Foundation

Collaborator

Trials

32

Recruited

15,700+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Among patients hospitalized for acute coronary syndrome (ACS), smoking cessation therapies show limited efficacy, with only varenicline demonstrating increased abstinence rates at 12 months in pharmacologic trials.

Behavioral interventions also improved smoking abstinence rates at 6 and 12 months, but the studies had significant limitations, highlighting the need for further research to establish effective smoking cessation guidelines for ACS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation in Patients With Acute Coronary Syndrome. Franck, C., Filion, KB., Eisenberg, MJ.[2022]

An intensive smoking cessation intervention for cardiac patients, involving bedside counseling and follow-up calls, resulted in a 62% abstinence rate at 12 months, compared to 46% in a minimal intervention group, indicating that more comprehensive support significantly improves quitting success.

Patients who underwent coronary artery bypass grafting (CABG) had higher rates of continuous abstinence (57%) compared to those admitted for acute myocardial infarction (39%), suggesting that the type of cardiac event may influence the effectiveness of smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial. Smith, PM., Burgess, E.[2022]

In a study of 302 smokers hospitalized with acute coronary syndrome, initiating varenicline treatment in-hospital significantly increased smoking abstinence rates at 24 weeks compared to placebo, with 47.3% of the varenicline group remaining abstinent versus 32.5% in the placebo group.

The safety profile of varenicline was comparable to placebo, with similar rates of serious adverse events and major cardiovascular events, suggesting it is a safe option for smoking cessation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline for Smoking Cessation in Hospitalized Patients With Acute Coronary Syndrome. Eisenberg, MJ., Windle, SB., Roy, N., et al.[2018]

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Smoking Cessation in Patients With Acute Coronary Syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Acute coronary syndrome: factors predicting smoking cessation. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking cessation after an acute coronary syndrome: immediate quitters are successful quitters. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Varenicline for Smoking Cessation in Hospitalized Patients With Acute Coronary Syndrome. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Nicotine and non-nicotine smoking cessation pharmacotherapies. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Smoking cessation in patients with acute coronary syndrome. [2008]

10. England pubmed.ncbi.nlm.nih.gov

Effect of Intensive Personalized "5As+5Rs" Intervention on Smoking Cessation in Hospitalized Acute Coronary Syndrome Patients Not Ready to Quit Immediately: A Randomized Controlled Trial. [2019]