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Trial record 35 of 2064 for:    Smoking Cessation

Integrated Smoking Cessation and Mood Management for ACS Patients (PACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03029923
Recruitment Status : Withdrawn (Funding for this pilot transitioned into funding for a fully powered study.)
First Posted : January 24, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Andrew Busch, The Miriam Hospital

Brief Summary:

Quitting smoking following acute coronary syndrome 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 R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Tobacco Use Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) Behavioral: Smoking cessation plus Health and Wellness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Integrated Smoking Cessation and Mood Management for ACS Patients (PACES Phase IV Vanguard R56 Trial)
Estimated Study Start Date : February 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoking Cessation and Mood Management
Participants will receive standard smoking cessation plus Behavioral Activation based mood management. Will be offered the nicotine patch if medically cleared.
Behavioral: Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)
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 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.

Active Comparator: Smoking cessation and Health and Wellness
Participants will receive standard smoking cessation plus health and wellness education. Will be offered the nicotine patch if medically cleared.
Behavioral: Smoking cessation plus Health and 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.




Primary Outcome Measures :
  1. Treatment Acceptability [ Time Frame: 12 weeks post-Discharge ]
    Treatment Acceptability as measured by the Client Satisfaction Questionnaire


Secondary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 12 weeks post-Discharge ]
    7 day point-prevalence abstinence. Biochemically verified.

  2. Depression Symptoms [ Time Frame: 12 weeks post-Discharge ]
    Depression Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. hospital inpatients with an ACS diagnosis documented in medical record,
  2. smoked 1 or more cigarettes per day before being hospitalized,
  3. age of 18-75,
  4. English fluency,
  5. lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
  6. willing to consider quitting smoking at discharge,
  7. has telephone, and
  8. willing to consent to all study procedures.

Exclusion Criteria:

  1. limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
  2. presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
  3. expected discharge to hospice; and
  4. currently attending counseling for depression or smoking cessation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029923


Locations
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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Andrew Busch, Assistant Professor, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03029923     History of Changes
Other Study ID Numbers: 214016
R56HL131711-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Busch, The Miriam Hospital:
smoking
depression
Behavioral Activation
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action