Summary

Eligibility
for people ages 24-64 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by Michelle Dossett, MD, PhD, MPH (ucdavis)

Description

Summary

This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.

Official Title

Physiology of GERD and Treatment Response

Details

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. Heart rate variability and galvanic skin response will be measured in the patient-provider dyads and the visits video recorded. Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with instructions for taking it. Subjects will complete a daily GERD symptom diary during the first and eighth weeks of the study. At the end of the 8-week observation period, subjects will complete follow-up measures of GERD symptom severity and quality of life.

Keywords

GERD Gastroesophageal Reflux Amitriptyline Amitriptyline, perphenazine drug combination

Eligibility

You can join if…

Open to people ages 24-64

  • Adults ages 24-64 years old
  • Functional heartburn (defined as <4% of time with reflux on 24 hour pH manometry) symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7-day baseline symptom diary
  • English language proficiency
  • Willingness to be videotaped and connected to physiologic monitoring devices during the visit
  • Willingness to take amitriptyline daily for 8 weeks following study visit 1

You CAN'T join if...

  • Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
  • Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men) based on subject self-report
  • Pregnant, attempting to become pregnant, or breast-feeding
  • Dementia or significant memory difficulties as determined by the study team and medical record review
  • Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review
  • Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants
  • Prolonged QTc or severe heart disease
  • History of seizure disorder
  • Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis
  • Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications
  • Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
  • Failure to complete the baseline symptom diary for at least 6 of 7 days
  • Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
  • Allergy to adhesives
  • Inability to provide informed consent
  • In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study

Location

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT04292470
Study Type
Interventional
Last Updated