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NCT03008590 · ClinicalTrials.gov registry record · Phase 2
Low Dose Naltrexone for Chronic Pain From Arthritis
A Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT03008590: Completed Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid, sponsored by VA Office of Research and Development.
NCT03008590 is a Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid that has completed, run by VA Office of Research and Development. The registered enrollment target is 29 participants, below the 818-participant average among 135 other Osteoarthritis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03008590, a Phase 2 study of Osteoarthritis and Arthritis, Rheumatoid, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Sum of 7 questions (each on a 0-10 scale, therefore 0-70 total) on how much pain has interfered with general function, walking ability, mood, normal work, relations with other people, sleep, and enjoyment of life. Higher score is a worse outcome. Results are reported as change from baseline: after 8 weeks of naltrexone, or after 8 weeks of placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naltrexone
Study Locations (1)
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
What the finished NCT03008590 record still lists
NCT03008590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 818-participant average among 135 other Osteoarthritis trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03008590 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03008590 about?
NCT03008590 is a clinical study titled "Low Dose Naltrexone for Chronic Pain From Arthritis". 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...
What is the current status of trial NCT03008590?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2018-05-01. Estimated completion is 2019-12-31.
What conditions does trial NCT03008590 study?
This clinical trial studies the following conditions: Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic.
What interventions are being tested in trial NCT03008590?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT03008590?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03008590 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03008590's enrollment target sits among peer trials
29 130th of 135 higher than 6 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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