CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Naltrexone 4.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03008590
NCT03008590Phase 2Completed

Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis

VA Office of Research and Development·interventional·Posted Jan 2, 2017·Updated Mar 3, 2021

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Placebo for Osteoarthritis and 2 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder. Treatment for chronic pain is a priority research area for the VA. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2, 2017
Enrollment StartMay 1, 2018
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.5 years ago

Interventions

Naltrexonedrug

One 4.5 mg capsule each evening

Placebodrug

One capsule each evening