Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease

October 31, 2007 updated by: Dartmouth-Hitchcock Medical Center

Endorphins are naturally occurring narcotic substances that are released when individuals perform exercise. The hypothesis of the study is that endorphins reduce the severity of breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). The initial five visits include familiarization and validation of a computerized system for patients to report dyspnea and leg discomfort continuously during exercise testing.

At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5 minutes prior to exercise in a double-blinded design. The primary outcome is the slope of oxygen consumption - dyspnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of COPD
  • Ability to exercise
  • Ability to computer mouse to provide ratings
  • > 10 pack-years smoking
  • Baseline dyspnea index < 9

Exclusion Criteria:

  • Clinically significant comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A: naloxone; B: normal saline
Arm A: IV naloxone Arm B: IV normal saline
Drug: naloxone versus placebo
10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits
Drug: intravenous injection of normal saline or naloxone
Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Slope of oxygen consumption - dyspnea during treadmill exercise.
Time Frame: throughout exercise
throughout exercise

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise duration
Time Frame: 10-14 minutes
10-14 minutes
Peak ratings of breathlessness
Time Frame: at end of exercsie - 10-15 minutes
at end of exercsie - 10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Doanld A Mahler, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

April 8, 2007

First Submitted That Met QC Criteria

April 9, 2007

First Posted (Estimate)

April 10, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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