Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction

September 18, 2023 updated by: Diana L. Snyder, Mayo Clinic

Prospective Evaluation of the Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction (OIED)

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients being seen in the Pain Rehabilitation Center for opioid cessation at Mayo Clinic Rochester.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Opioid Cessation
Subjects able to complete opioid cessation.
Non-Opioid Cessation
Subjects unable to complete opioid cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects to have opioid-induced esophageal dysfunction resolution
Time Frame: 4 weeks
Number of subjects to have resolution of opioid-induced esophageal dysfunction
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with dysphagia
Time Frame: 4 weeks
Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have dysphagia
4 weeks
Number of subjects with chest pain
Time Frame: 4 weeks
Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have chest pain
4 weeks
Number of subjects with opioid-induced esophageal dysfunction
Time Frame: 4 weeks
Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have opioid-induced esophageal dysfunction
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Diana Snyder, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-001879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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