Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction

Recruiting

• Conditions: Opioid-Induced Esophageal Dysfunction
• Interventions: Behavioral: Opioid cessation; Other: No opioid cessation

• Registration Number: NCT05854303
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to evaluate the effect of opioid cessation on opioid-induced esophageal dysfunction (OIED).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-11
• Study Start: 2023-09-18
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients enrolled in the Pain Rehabilitation Center for opioid cessation, with or without esophageal symptoms.

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Exclusion Criteria

• Inability to provide informed consent.
• Patients with previous gastroesophageal surgery or pneumatic dilation.
• Esophageal botulinum toxin injection within the prior 12 months.
• Esophageal stricture
• Achalasia types I and II
• Allergy to Lidocaine or other local anesthetics
• Subjects on anticoagulation
• Bilateral nasal obstruction
• Pregnancy or breast feeding

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Opioid Cessation	Opioid cessation	Subjects able to complete opioid cessation.
Non-Opioid Cessation	No opioid cessation	Subjects unable to complete opioid cessation.

Primary Outcome Measures

Name	Time	Method
Number of subjects to have opioid-induced esophageal dysfunction resolution	4 weeks	Number of subjects to have resolution of opioid-induced esophageal dysfunction

Secondary Outcome Measures

Name	Time	Method
Number of subjects with opioid-induced esophageal dysfunction	4 weeks	Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have opioid-induced esophageal dysfunction
Number of subjects with dysphagia	4 weeks	Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have dysphagia
Number of subjects with chest pain	4 weeks	Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have chest pain

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States