Acupuncture and Opioid Response in Fibromyalgia

This study is looking at whether traditional acupuncture can help people with fibromyalgia who are already taking opioid pain medications. Researchers want to see if acupuncture can make the pain-reducing effects of opioids stronger compared to a sham (fake) acupuncture treatment. You might be able to join if you are 18-80 years old, have had fibromyalgia for over 6 months, are currently taking opioid pain medication like Hydrocodone or Oxycodone daily, and have moderate to excruciating pain. The main goal is to measure how much your pain changes after taking an opioid, comparing results before and after receiving either traditional or sham acupuncture. The study plans to enroll 45 participants, but its current recruitment status is unclear.

Study design
This interventional study will involve 45 participants. It compares traditional acupuncture to sham acupuncture to see their effects.
What's involved
Participants will complete a pain inventory during an opioid challenge before therapy and one week after acupuncture therapy is completed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured after the first and last study treatment session, which are 2 weeks apart.

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NCT06571110

Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture

Recruiting
NAAges 18–80InterventionalSupportive care
University of California, Irvine
~45 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Traditional AcupunctureSham Acupuncture

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA
Measured over Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
Fibromyalgia
1 sites across 1 states
California1
  • Ariana Nelson, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine

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Eligibility criteria

Inclusion

Are 18 - 80 years old
have been diagnosed with Fibromyalgia for more than 6 months
Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily
Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)

Exclusion

Are younger than 18 or older than 80 years old
Have been diagnosed with a Substance Use Disorder (SUD)
Pregnant
Have an active litigation or worker's compensation case
Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation
Are prescribed and actively using low dose Naltrexone . Have tried acupuncture in the last 6 months
  • Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SAChange in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).

    We hypothesize that patients randomized to TA treatment will have a statistically greater change in pain after the final opioid challenge compared to the initial opioid challenge, as compared to patients randomized to SA treatment(p-value set at 0.05).