Recruiting NCT05854303
Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid cessation, No opioid cessation.
- Who it may be relevant to
- Registry conditions: Opioid-Induced Esophageal Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of the Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction (OIED)
Overview
The purpose of this study is to evaluate the effect of opioid cessation on opioid-induced esophageal dysfunction (OIED).
Interventions
- Behavioral Opioid cessation
opioid cessation will occur during pain rehabilitative program over approximately 3 weeks - Other No opioid cessation
Subjects will not stop taking opioids
Primary outcome measures
- Number of subjects to have opioid-induced esophageal dysfunction resolution [Time frame: 4 weeks]
Secondary outcome measures (3)
- Number of subjects with dysphagia [Time frame: 4 weeks]
- Number of subjects with chest pain [Time frame: 4 weeks]
- Number of subjects with opioid-induced esophageal dysfunction [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
\- Patients enrolled in the Pain Rehabilitation Center for opioid cessation, with or without esophageal symptoms.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05854303 · 23-001879