Esophageal Dysfunction Associated With Opioids: Clinical Response and Manometric Findings After Opioid Discontinuation
NCT Number: NCT06522633
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use
Interventions: DRUG: The intervention involves the discontinuation of the opioid.
Sponsor: Hospital Clinic of Barcelona
Collaborators: Vall Hebron Insitut Recerca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2020-11-01
Completion Date: 2024-08-05
Locations: Hospital Clínic of Barcelona, Barcelona, 08036, Spain

Summary:
Background: Opioid-induced esophageal dysfunction is characterized by altered motility of the esophageal body or impaired function of the esophageal sphincters secondary to chronic opioid use. The diagnosis of this condition is made through high-resolution manometry. Following the discontinuation of opioid treatment, most patients experience a clear symptomatic improvement.

Hypothesis: Opioids induce alterations in esophageal motility and esophageal sphincter function that revert after discontinuation of treatment.

Outcome: To demonstrate through high-resolution esophageal manometry that the manometric alterations described in patients with chronic opioid use are secondary to opioid consumption and disappear after discontinuing use.

Methods: In a group of patients with chronic opioid use and diagnosed with a major esophageal motor disorder through high-resolution esophageal manometry, a new high-resolution manometry will be performed after discontinuing opioid treatment for at least 7 days to assess any changes compared to the previous manometry.

The treating physician will be contacted to inform them about the manometry findings and to consider the possibility of discontinuing opioid treatment. Patients will be informed about the association between opioids and esophageal motor disorders and the benefits of discontinuing the medication to evaluate the resolution of symptoms and the observed disorder.

To avoid complications such as withdrawal syndrome or exacerbation of pain due to the reduction of analgesic medication, an alternative medication protocol will be used according to the recommendations of the psychiatry team associated with functional digestive disorders.

Relevance: This project will determine whether the manometric alterations are primary or secondary to opioid treatment. If it is confirmed that they are secondary to the treatment, opioid treatment can be replaced with another analgesic treatment, and esophageal symptoms will improve without the need for more aggressive therapies.

Primary Outcome Measures: Improvement in Esophageal Motility Demonstrate the improvement in esophageal motility in chronic opioid users after discontinuation of opioids., Assessment Tool: High-resolution esophageal manometry (HREM). Unit of Measure: Manometric parameters (e.g., integrated relaxation pressure (IRP) in mmHg).

Prospective multicenter study in patients referred for non-obstructive dysphagia that were on chronic opioid treatment (\> 3 months).

Patients were evaluated during the initial referral and then after 7 days without opioid use.

In each visit, patients underwent a high-resolution esophageal manometry following the Chicago 4.0 protocol., Baseline (prior to opioid discontinuation) and 7 days post-opioid discontinuation
Secondary Outcome Measures: Improvement in Dysphagia Severity Demonstrate the improvement in dysphagia severity in chronic opioid users after discontinuation of opioids., Change in dysphagia severity

-Assessment Tool: Dysphagia Severity Score. Unit of Measure: Dysphagia score (numeric scale). Assessment Points: Baseline (during opioid treatment) and after 7 days of opioid discontinuation., Baseline (prior to opioid discontinuation) and 7 days post-opioid discontinuation