Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chest Pain
Intervention: Imipramine (Drug); Cognitive-behavior therapy (Behavioral)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s):
Laurence A. Bradley, Principal Investigator, Affiliation: University of Alabama at Birmingham
Summary
Approximately 75,000-150,000 patients each year in the United States undergo intensive
cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings.
These patients often have high levels of disability and suffering and account for
$250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence
from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of
training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term
reductions in pain intensity. However, no studies have compared the effects of these two
treatments on measures of pain, suffering, and disability at post-treatment and over a
one-year follow-up period.
Our investigation is a 16-week, randomized controlled outcome study of these interventions
and their respective placebo control procedures. One hundred and sixty patients are being
recruited for this study. We will assess the effects of our interventions on patients' pain
levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month
follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our
treatment effects as well as their statistical significance.
Clinical Details
Official title: Psychophysiological Interactions in Non-Cardiac Chest Pain
Study design: Treatment, Randomized, Single Blind, Placebo Control
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Substernal chest pain at least 2X per week for at least 3 months;
- Angiographic evidence of normal or non-obstructive (<50% luminal diameter narrowing)
coronary arteries among subjects > 40 years of age; OR Normal exercise stress tests,
normal echocardiogram, and cardiologist evaluation that symptoms are not cardiac in
origin among subjects < 40 years of age;
- Gastroesophageal reflux disease ruled out by 24-hour pH monitoring, endoscopy, or
1-month trial of anti-reflux therapy with omeprazole 20 mg bid;
- Pain threshold levels for esophageal balloon distention must be 12 ml.
Exclusion Criteria:
- Mitral valve prolapse
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information
Related publications: Bradley LA, Richter JE, Scarinci IC, Haile JM, Schan CA. Psychosocial and psychophysical assessments of patients with unexplained chest pain. Am J Med. 1992 May 27;92(5A):65S-73S. Mayou RA, Bryant BM, Sanders D, Bass C, Klimes I, Forfar C. A controlled trial of cognitive behavioural therapy for non-cardiac chest pain. Psychol Med. 1997 Sep;27(5):1021-31. Cannon RO 3rd, Quyyumi AA, Mincemoyer R, Stine AM, Gracely RH, Smith WB, Geraci MF, Black BC, Uhde TW, Waclawiw MA, et al. Imipramine in patients with chest pain despite normal coronary angiograms. N Engl J Med. 1994 May 19;330(20):1411-7.
Starting date: January 1999
Ending date: December 2002
Last updated: June 23, 2005
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