Codeine on Pharyngeal and Esophageal Motility

Study Overview
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Brief Summary
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Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).

Official Title
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Effect of Codeine on Pharyngeal and Esophageal Motility in Healthy Subjects: a Double-blind, Placebo-controlled, Randomized, Cross-over Study

Conditions
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Esophageal Motility Disorders

Intervention / Treatment
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* Drug: Codeine Phosphate
* Drug: Siripus simplex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between 18-60 years old Written informed consent Exclusion Criteria: No chronic disease/medication No GI symptoms Not pregnant or breast-feeding No history of head/neck surgery Not allergic to codeine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Codeine<br> | Drug: Codeine Phosphate<br>* 30 mL of codeine phosphate 10mg/5mL<br>|
| Placebo Comparator: Siripus simplex<br> | Drug: Siripus simplex<br>* Sugar syrup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in distal contractile integral | The difference in distal contractile integral between the codeine and placebo condition | 1 week | 
| Difference in integrated relaxation pressure | The difference in integrated relaxation pressure between the codeine and placebo condition | 1 week | 
| Difference in distal latency | The difference in distal latency between the codeine and placebo condition. | 1 week | 
| Difference in pressure flow | The difference in pressure flow between the codeine and placebo condition | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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codeine, Esophageal motility, Pharyngeal motility