Post Acute Cardiac Event Smoking (PACES) Study

NCT ID: NCT03413423

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2026-05-30

Brief Summary

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).

Detailed Description

This project will implement a fully powered efficacy trial enrolling 324 smokers with ACS and randomize them to 12 weeks of either Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) or control condition (including contact match). BAT-CS interventions will focus on smoking cessation and mood management, while the control condition will focus on smoking cessation and general health education. Both groups will be offered the nicotine patch if medically safe. Follow-up assessments will be conducted at end-of-treatment (12 weeks post-discharge for index event), and 6, 9, and 12 months after hospital discharge. The occurrence of major adverse cardiac events and all-cause mortality will be tracked for up to 60 months post discharge.

Conditions

Acute Coronary Syndrome; Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BAT-CS

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

Group Type: EXPERIMENTAL

BAT-CS

Intervention Type: BEHAVIORAL

All participants will receive one hour standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.

Smoking Cessation and Health & Wellness

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

Group Type: ACTIVE_COMPARATOR

Smoking Cessation and Health & Wellness

Intervention Type: BEHAVIORAL

All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking Cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.

Interventions

BAT-CS

All participants will receive one hour standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.

Intervention Type: BEHAVIORAL

Smoking Cessation and Health & Wellness

All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking Cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.

Intervention Type: BEHAVIORAL

Other Intervention Names

Smoking Cessation and Mood Management

Eligibility Criteria

Inclusion Criteria

• hospital inpatients with an ACS diagnosis documented in medical record within the past 30 days
• smoked equal or greater than 1 cigarette per day before being hospitalized
• age of 18-75 years
• English fluency
• willing to consider quitting smoking at discharge
• has a telephone or is willing to use a study issued cell phone
• willing to consent to all study procedures.

Exclusion Criteria

• limited mental competency
• presence of severe mental illness that would interfere with participation or suicidality
• expected discharge to hospice or greater than 50% chance of 6 month mortality per risk calculator
• currently attending counseling for depression or smoking cessation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Andrew Busch

Senior Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Busch, PhD

Role: PRINCIPAL_INVESTIGATOR

Senior Investigator

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

Adkins-Hempel M, Japuntich SJ, Chrastek M, Dunsiger S, Breault CE, Ayenew W, Everson-Rose SA, Nijjar PS, Bock BC, Wu WC, Miedema MD, Carlson BM, Busch AM. Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial. Addict Sci Clin Pract. 2023 May 12;18(1):29. doi: 10.1186/s13722-023-00388-9.

Reference Type: BACKGROUND

PMID: 37173792 (View on PubMed)

Related Links

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

Protocol paper

Other Identifiers

1R01HL136327

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-4375

Identifier Type: -

Identifier Source: org_study_id