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

NCT02806440 | Completed Phase 4 DMC

• 1 other identifier: 2015-002972-26
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. The study takes place at The Multidisciplinary Pain Center in Grindsted.

Conditions

Fibromyalgia

Keywords

Low dose naltrexone; Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain scores (during rest, during household activity, during personal daily hygienic procedures)

  The patient indicates using a questionnaire-based numerical rating scale (0 = no pain; 100 = worst imaginable pain) mean values of pain at rest, pain during household activity and pain during personal hygienic procedures in the preceding 24 hrs. The cumulated pain scores are used in the statistical analyses.

  Baseline: Day -2 to day 1 (baseline before treatment 1); Treatment 1: Day 19 to 21 ; Washout: Day 33 to 35 (baseline before treatment 2); Treatment 2: Day 54 to 56

Secondary Outcomes (10)

• Fibromyalgia Impact Questionnaire Revised (FIQR)

  Before baseline: Day -3; Treatment 1: Baseline (Day 1) + Day 14 + 21 ; Washout: Before baseline day -3; Treatment 2: Baseline (Day 35) + Day 49 + 56

• Daily Sleep Interference Scale (DSIS)

  Diary (Treatment 1: baseline (Day 1) to Day 21; Treatment 2: baseline (Day 35) to Day 56)

• Pressure algometry (1 sq.cm probe)

  Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56

• Hospital Anxiety and Depression Scale (HADS)

  Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56

• Pain Catastrophizing Scale (PCS)

  Treatment 1: Baseline (Day 1) + Day 14 + Day 21; Treatment 2: Baseline (Day 35) + Day 49 + Day 56

Study Arms (2)

Low dose naltrexone

ACTIVE COMPARATOR

Low dose naltrexone 4.5 mg/tablet, 1 tablet a day for 21 days

Drug: Low dose naltrexone

Placebo

PLACEBO COMPARATOR

Placebo tablet 1 tablet a day for 21 days

Drug: Placebo

Interventions

Low dose naltrexone DRUG

Active comparator

Also known as: Naltrexone

Low dose naltrexone

Placebo DRUG

Placebo comparator

Also known as: Inert substance

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Multidisciplinary Pain Centre

Grindsted, 7200, Denmark

Location

Related Publications (7)

• Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16.

  PMID: 22607834 BACKGROUND

• Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

  PMID: 24737367 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

• Gilron I, Jensen TS, Dickenson AH. Combination pharmacotherapy for management of chronic pain: from bench to bedside. Lancet Neurol. 2013 Nov;12(11):1084-95. doi: 10.1016/S1474-4422(13)70193-5. Epub 2013 Sep 25.

  PMID: 24074723 BACKGROUND

• Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014 Apr;33(4):451-9. doi: 10.1007/s10067-014-2517-2. Epub 2014 Feb 15.

  PMID: 24526250 BACKGROUND

• Younger JW, Zautra AJ, Cummins ET. Effects of naltrexone on pain sensitivity and mood in fibromyalgia: no evidence for endogenous opioid pathophysiology. PLoS One. 2009;4(4):e5180. doi: 10.1371/journal.pone.0005180. Epub 2009 Apr 13.

  PMID: 19365548 RESULT

• Younger J, Noor N, McCue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 2013 Feb;65(2):529-38. doi: 10.1002/art.37734.

  PMID: 23359310 RESULT

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kirsten M Bested, MD

  Multidisciplinary Pain Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DMSc

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)