Inhaled Fentanyl Citrate & Dyspnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-08-31

Brief Summary

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"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the perception of dyspnea during strenuous exercise in healthy, young men in the presence of an external thoracic restriction. To this end, the investigators plan compare the effects of inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing with and without external thoracic restriction in healthy, men aged 20-40 years.

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Detailed Description

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Conditions

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Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CWS+Fentanyl Citrate (250 mcg)

Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg)

Group Type EXPERIMENTAL

Fentanyl Citrate

Intervention Type DRUG

CWS

Intervention Type OTHER

Chest wall strapping to reduce vital capacity by 20% of its baseline value

CWS+0.9% saline placebo

Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo

Group Type PLACEBO_COMPARATOR

CWS

Intervention Type OTHER

Chest wall strapping to reduce vital capacity by 20% of its baseline value

Placebo

Intervention Type DRUG

0.9% saline

No CWS+Fentanyl Citrate (250 mcg)

No chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg)

Group Type ACTIVE_COMPARATOR

Fentanyl Citrate

Intervention Type DRUG

No CWS+0.9% saline placebo

No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% saline

Interventions

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Fentanyl Citrate

Intervention Type DRUG

CWS

Chest wall strapping to reduce vital capacity by 20% of its baseline value

Intervention Type OTHER

Placebo

0.9% saline

Intervention Type DRUG

Other Intervention Names

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chest wall strapping

Eligibility Criteria

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Inclusion Criteria

* Male
* Aged 20-40 years
* FEV1 ≥80% predicted
* FEV1/FVC \>70%

Exclusion Criteria

* Current or ex-smoker
* Body Mass Index \<18.5 or \>30 kg/m2
* History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
* Taking doctor prescribed medications
* History of using pain-relieving (opioid) and/or anti-depressant medications in the previous 6 weeks
* Allergy to latex
* Allergy to lidocaine or its "caine" derivatives

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes