Chest PainPhase 3NCT00005575
Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy
A Phase 3 study testing Imipramine and Cognitive-behavior therapy in people with Chest Pain, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Imipramine and Cognitive-behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mitral valve prolapse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Psychophysiological Interactions in Non-Cardiac Chest Pain
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.
- Conditions
- Chest Pain
- Being tested
- Imipramine, Cognitive-behavior therapy
- Keywords
- Imipramine, Cognitive-Behavioral Therapy
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImipramineDrug
Cognitive-behavior therapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2000 (estimated)
- Study startJan 1999
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Laurence A. Bradley, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005575
- Sponsor's protocol ID
- NCCP (completed)
- Other IDs
- 42428-06
- Status last verified
- Jan 2010
- First submitted
- 1 May 2000
- Last updated
- 13 Jan 2010
- Results posted
- No
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. doi: 10.1016/0002-9343(92)80059-9.
PubMed 1595768Mayou 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. doi: 10.1017/s0033291797005254.
PubMed 9300508Cannon 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. doi: 10.1056/NEJM199405193302003.
PubMed 8159194
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Interactions in Non-Cardiac Chest Pain
- ClinicalTrials.gov ID
- NCT00005575
- Acronym / sponsor ID
- NCCP (completed)
- Conditions
- Chest Pain
- Keywords
- Imipramine, Cognitive-Behavioral Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jan 1999
- Study completion
- Dec 2002
- First posted
- 2 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Mitral valve prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imipramine | Drug | – |
| Cognitive-behavior therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 1595768Bradley 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. doi: 10.1016/0002-9343(92)80059-9.
- Background: PubMed 9300508Mayou 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. doi: 10.1017/s0033291797005254.
- Background: PubMed 8159194Cannon 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. doi: 10.1056/NEJM199405193302003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence A. Bradley principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imipramine and Cognitive-behavior therapy in people with Chest Pain, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005575, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010; AzTrials last refreshed its copy on 8 Nov 2026.