Duloxetine Metabolism and Fibromyalgia

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06866444
Status
Recruiting
Apply to this trial

Conditions

  • Duloxetine
  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational — DRUG
    In a cohort of patients treated with duloxetine for fibromyalgia, participants vitals signs (blood pressure, heart rate, oxygen saturation level, temperature) will be taken as well as height and weight. Participants will fill out a questionnaire regarding their fibromyalgia diagnosis and symptoms. Lastly, participants will complete two sets of blood samples. One blood sample will evaluate genetic variants for duloxetine metabolizing capacity. The other sample will be used to analyze the level of concentration of duloxetine.

Study Details

People with fibromyalgia report generalized body pain ("pain all over"), increased sensitivity to painful stimulation, chronic tiredness or low energy, sleep problems, and other physical and functional problems. The exact cause of the disorder is poorly understood, and treatment can be difficult. The degree to which duloxetine is helpful for people with fibromyalgia varies greatly. For some people, it is very helpful for managing fibromyalgia symptoms. For others, people may not notice any benefit. Yet for some, it is a little helpful and the effect is noticeable only when people forget to take the medicine. The purpose of this study is to collect data to better understand the relationship among gene types that control those enzymes, blood concentrations of duloxetine, and how it helps the symptoms.

Key Dates

Start date
May 1, 2025
Status verified
Jul 2025
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Adult patients treated with duloxetine for fibromyalgia
    Adults 18+ Meeting diagnostic criteria for Fibromyalgia Patients taking Duloxetine 60 mg/day for at least 8 weeks

Primary Outcome Measure

Duloxetine concentrations across metabolizer phenotypes, 3 groups [ Time Frame: Obtained four hours after morning duloxetine dose. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pain Management Center and Pain Research Center at the University of UtahSalt Lake CityUtah84132
Jake Steenblick, DNP
[email protected]
801-585-1216

Find similar trials in Salt Lake City, UT

By research site
Pain Management Center and Pain Research Center at the University of Utah· Salt Lake City, UT

Related Studies