Recruiting

Duloxetine

Sponsor:

University of Utah

Code:

NCT06866444

Conditions

Fibromyalgia

Duloxetine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational

Study Details

Brief summary:

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.

Conditions

Fibromyalgia

Duloxetine

Study ID

NCT06866444

Start date

May 1, 2025

Status verified date

Jul, 2025

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18+
  • Meeting diagnostic criteria for Fibromyalgia
  • Patients taking Duloxetine 60 mg/day for at least 8 weeks

Exclusion Criteria:

  • Pregnant patients per verbal confirmation
  • Patients that have a history of physician diagnosed kidney or liver disfunction or history of renal dialysis.
  • Patients requiring an interpreter to communicate
  • Patient's with progressive illnesses other than fibromyalgia that have a chronic pain and fatigue component (e.g., cancer patients receiving antineoplastic treatment, Parkinson's disease, Multiple Sclerosis).

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Observational

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.

Primary outcome measure

  • Duloxetine concentrations across metabolizer phenotypes, 3 groups [ Time Frame: Obtained four hours after morning duloxetine dose. ]
  • Measure inhibitors and inducers of CYP1A2 and CYP2D6 in blood sample [ Time Frame: Obtained four hours after the morning duloxetine dose. ]

Central Contacts and Locations

Central contacts

Jake Steenblick, DNP

801-585-1216jacob.steenblik@nurs.utah.edu

Natalie R Bennion, MPH

801-585-7697Natalie.Bennion@utah.edu

Locations

Pain Management Center and Pain Research Center at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Jake Steenblick, DNP

801-585-1216jacob.steenblik@nurs.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Aug 21, 2025

Last verified

Jul, 2025

Keywords

  • Duloxetine
  • Duloxetine metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-08-21.