CompletedPhase 4

Opioid Effects on Swallowing and Esophageal Sphincter Pressure

Sweden14 participantsStarted 2010-10

Plain-language summary

The purpose of this study is to determine whether a dopamine receptor antagonist metoclopramide can counteract opioid induced effects on esophageal motility and lower esophageal sphincter. The aim of this study is also to evaluate if the opioid antagonist naloxone reduces the opioid induced pharyngeal and esophageal dysfunction.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion criteria

✓. 18 - 40 year old healthy volunteers from both sexes.
✓. Have signed and dated Informed Consent.
✓. Willing and able to comply with the protocol for the duration of the trial.

Exclusion criteria

✕. Anamnesis of pharyngoesophageal dysfunction
✕. Known history of cardiac, pulmonary or neurological disease
✕. Ongoing medication
✕. Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or metoclopramide
✕. Pregnancy or breast feeding
✕. BMI \> 30
✕. Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed.

What they're measuring

Lower esophageal sphincter pressure

Timeframe: 2 hours

Trial details

NCT IDNCT01191645

SponsorRegion Örebro County

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

View on ClinicalTrials.gov More Opioid Induced Pharyngeal and Esophageal Dysfunction trials