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Recruiting

NCT Number: NCT05854303

Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction

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

Recruiting

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Key information

Conditions

Opioid-Induced Esophageal Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid cessation

Behavioral

opioid cessation will occur during pain rehabilitative program over approximately 3 weeks

No opioid cessation

Other

Subjects will not stop taking opioids

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mariah Robran

CONTACT

[email protected]

507-266-3595

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 11, 2023
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.