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Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis

NCT04115020 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-09

No results posted yet for this study

Summary

Over 100 million Americans report chronic pain. One of the most common causes of chronic pain is osteoarthritis (OA). OA is attributable to "wear and tear," but reasons for pain are complex. Inflammatory arthritis (IA) includes multiple severe diseases that affect 2-3% of persons and require treatment with immune-suppressive drugs to prevent joint destruction. Pain often persists despite effective treatment. Pain in arthritis results from multiple sources: inflammation, perception of pain in the joint, and interpretation of pain by the brain. Unfortunately, management of pain in arthritis remains a challenge. Low dose naltrexone is a widely used but unproven "alternative" approach to chronic pain. It is attractive for study because it is safe and is proposed to work on all three pathways that contribute to pain. A small but high-quality clinical trial is needed to determine whether to invest in definitive studies.

Conditions

Interventions

DRUG

Naltrexone

Naltrexone 4.5 mg oral suspension

DRUG

Placebo

Placebo oral suspension

Sponsors & Collaborators

  • VA Boston Healthcare System

    collaborator FED

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Paul Monach, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-01-07
Completion
2020-01-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115020 on ClinicalTrials.gov