Overview

Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism?

Status:
Unknown status

Trial end date:
2017-12-01

Target enrollment:
0

Participant gender:
All

Summary

This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study. It is a 2-center study that takes place at The Multidisciplinary Pain Center in Copenhagen and at The Multidisciplinary Pain Center in Give.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rigshospitalet, Denmark

Treatments:

Naltrexone

Criteria

Patients diagnosed with fibromyalgia based on the criteria of American College of
Rheumatology.

Inclusion Criteria:

- Widespread pain in patients with fibromyalgia (based on the above criteria)

- Enrolled as a patient in one of the multidisciplinary pain clinics involved in the
project

- Inflammatory rheumatic disease (peripheral inflammation, including arthritis), must be
excluded

- Women must be treated with a contraceptive measure, if not menopausal

Exclusion Criteria:

- Cancer

- Treatment with opioids (other analgesic treatments in stabile dose 14 days prior to
study start are allowed)

- Change in stabile treatment (p.n. paracetamol is allowed, but must be registered)

- Pregnant/breastfeeding

- Does not speak/understand Danish

- Allergy to the ingredient

- Severe liver impairment

- Severe kidney impairment

- Acute hepatitis