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NCT03029923: PACES
Integrated Smoking Cessation and Mood Management for ACS Patients
NA trial testing Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS) in Acute Coronary Syndrome. Withdrawn.
1 October 2017
Quick facts
| Lead sponsor | The Miriam Hospital |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Start date | 1 February 2017 |
| Primary completion | 1 October 2017 |
| Estimated completion | 1 December 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)
- Smoking cessation plus Health and Wellness
Conditions studied
- Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
- Tobacco Use — all drugs for Tobacco Use →
Sponsor
The Miriam Hospital
Who can join
Adults 18 to 75, any sex, with Acute Coronary Syndrome or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03029923
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other The Miriam Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03029923 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Miriam Hospital
- Last refreshed: 29 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03029923.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing