Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fibromyalgia and Naltrexone: The FINAL Study

NCT04270877

Fibromyalgia

COMPLETED PHASE2

Effects of Low Dose Naltrexone in Fibromyalgia

NCT00568555

Fibromyalgia Persian Gulf Syndrome

COMPLETED NA

Low Dose Naltrexone (LDN) Immune Monitoring

NCT02107014

Fibromyalgia

COMPLETED NA

LDN and tDCS in Fibromyalgia

NCT04502251

Fibromyalgia

COMPLETED PHASE2/PHASE3

Low-Dose Naltrexone For ME/CFS: Dose-Finding

NCT07285473

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fibromyalgia syndrome is a prevalent musculoskeletal disorder characterized by pain, profound fatigue, sleep disorder, mood disturbance etc. The prevalence is estimated to be 2-8%.

Treatment of pain in patients with fibromyalgia is often based on opioids. However, opioids may lead to tolerance, addiction and hyperalgesia and alternative treatments are therefore warranted.

Low dose naltrexone (3-5mg) (LDN) has shown promising results in the treatment of pain in patients with fibromyalgia, but there is a need for further research.

At the typical dose of naltrexone, 50 mg, it is an opioid antagonist. However LDN demonstrates analgesic and anti-inflammatory effects, possibly involving an antagonism of microglia in the CNS.

The investigators hypothesize, that LDN has a better pain relieving effect than placebo in in patients with fibromyalgia (FM). The investigators also hypothesize that LDN has a better effect upon experimentally induced pain in FM-patients, compared to placebo. A tentative mechanism is a central facilitation of the endogenous pain inbitory system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low dose naltrexone

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

Group Type ACTIVE_COMPARATOR

Low dose naltrexone

Intervention Type DRUG

Active comparator

Placebo

Placebo tablet

1 tablet a day for 21 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low dose naltrexone

Active comparator

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Naltrexone Inert substance

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No