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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people quit smoking after experiencing acute coronary syndrome (ACS), such as a heart attack. The study combines smoking cessation support with depression management, as depression can hinder quitting efforts. Participants will receive either standard smoking cessation help or a special program called BAT-CS, which is a behavioral therapy incorporating mood management techniques. The trial seeks individuals who have had a heart issue in the last 30 days, smoked regularly before hospitalization, and are considering quitting smoking upon discharge. As an unphased trial, it offers a unique opportunity to explore innovative methods for smoking cessation and mood management.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) helps people quit smoking while managing depression. Studies have found this combined approach effective.

Regarding safety, BAT-CS builds on treatments already known to be safe. It combines standard smoking cessation methods with mood-improving techniques. These components have been used separately without major safety issues.

In past studies, participants did not report unusual or severe side effects, indicating that BAT-CS is well-tolerated by individuals with heart problems. Additionally, nicotine patches, used in the program when approved by a doctor, are a common and generally safe method to aid smoking cessation.

Overall, evidence suggests that BAT-CS is a safe choice for those wanting to quit smoking after a heart issue while also focusing on mood improvement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BAT-CS for smoking cessation after acute coronary syndrome because it incorporates Behavioral Activation-based mood management, which is a unique feature compared to standard options that primarily focus on nicotine replacement and counseling. This approach aims to address mood and behavioral factors that can influence smoking habits, potentially offering a more comprehensive solution for individuals struggling to quit after a heart attack. By combining mood management with traditional cessation methods like the nicotine patch, BAT-CS may enhance the chances of successfully quitting smoking and improving heart health.

What evidence suggests that this trial's treatments could be effective for smoking cessation after acute coronary syndrome?

Research has shown that combining smoking cessation support with mood management, as in the BAT-CS program, can help individuals quit smoking after a heart event. In this trial, participants in the BAT-CS arm will receive standard smoking cessation along with Behavioral Activation-based mood management. This combined approach addresses both smoking and depression, which are often linked and can increase the risk of heart issues. Studies have demonstrated that Behavioral Activation (BA), a technique used in BAT-CS, effectively treats depression and can also aid in quitting smoking. By addressing both issues simultaneously, BAT-CS aims to lower the chances of future heart problems and reduce the risk of death after a heart event. Participants in the Smoking Cessation and Health & Wellness arm will receive standard smoking cessation plus health and wellness education. ^{1 2 4 6 7}

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

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5392972/

Behavioral activation for smoking cessation and mood ... A single, integrated treatment targeting both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01964898

NCT01964898 | Post Acute Coronary Event Smoking Study Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses ...

3. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-023-00388-9

Protocol for the post-acute cardiac event smoking (PACES) trial A single, integrated treatment targeting depressed mood and smoking could be effective in reducing post-ACS mortality.

4. mdpi.com mdpi.com/2077-0383/14/4/1388

Smoking Cessation Strategies After Acute Coronary ... It showed that there is no significant increased risk of adverse cardiovascular events in patients admitted with acute coronary syndrome who are prescribed ...

5. withpower.com withpower.com/trial/phase-acute-coronary-syndrome-2018-02cfa

Integrated Treatment for Smoking Cessation After Acute ... 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175930/

Protocol for the post-acute cardiac event smoking (PACES) trial Approximately 400,000 people who smoke cigarettes survive Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial ...

7. researchgate.net researchgate.net/publication/316168353_Behavioral_activation_for_smoking_cessation_and_mood_management_following_a_cardiac_event_results_of_a_pilot_randomized_controlled_trial

Behavioral activation for smoking cessation and mood ... At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: ...