Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis

NCT04115020 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2019P001799
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory - Pain Interference

  Average of 7 questions on how much pain has interfered with general function, walking ability, mood, normal work, relations with other people, sleep, and enjoyment of life

  16 weeks

Secondary Outcomes (10)

• Brief Pain Inventory - Pain Severity

  16 weeks

• painDETECT

  16 weeks

• Brief Fatigue Inventory

  16 weeks

• PROMIS-29

  16 weeks

• Beck Depression Inventory-II

  16 weeks

Study Arms (2)

Naltrexone first then placebo

EXPERIMENTAL

Naltrexone for 8 weeks, then placebo for 8 weeks, blinded cross-over design

Drug: Naltrexone; Drug: Placebo

Placebo first then naltrexone

EXPERIMENTAL

Placebo for 8 weeks, then naltrexone for 8 weeks, blinded cross-over design

Drug: Naltrexone; Drug: Placebo

Interventions

Naltrexone DRUG

Naltrexone 4.5 mg oral suspension

Naltrexone first then placebo; Placebo first then naltrexone

Placebo DRUG

Placebo oral suspension

Naltrexone first then placebo; Placebo first then naltrexone

Eligibility Criteria

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

You may qualify if:

• One or more of the following chronic conditions: osteoarthritis, rheumatoid arthritis, or non-axial spondyloarthritis
• Average daily pain interference with function (average of the 7 parts of question 9 on the Brief Pain Inventory) rated at least 4 on a scale of 0-10, and no higher than 9
• No change in medication in the past 8 weeks made with the expectation of improving pain
• No plan to start another medication or a non-pharmacologic treatment regimen likely to affect pain during the next 16 weeks
• Age at least 18
• Capable of informed consent, and willingness to comply with study procedures, including receipt of weekly phone calls from the study coordinator

You may not qualify if:

• Use of opioids including tramadol, in the past 7 days
• Pregnant, breast feeding, or unwilling to engage in contraceptive practices if sexually active and capable of conceiving
• Schizophrenia, bipolar disorder, or poorly controlled depression or anxiety
• Previous use of low-dose naltrexone for more than 8 weeks or in the past 2 weeks
• Back pain described by the patient as greater in severity than arthritic pain in all peripheral locations
• Significant kidney disease, defined as glomerular filtration rate \< 30 ml/min
• Liver cirrhosis. There is no specific screening procedure to exclude cirrhosis.
• Peripheral neuropathy described by the patient as greater in severity than arthritic pain. There is no specific screening procedure.
• Plan to have surgery during the next 16 weeks
• Other qualitative circumstances that the investigator feels would make the patient a poor candidate for this clinical trial, such as an unstable social situation or unreliable transportation

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• VA Boston Healthcare System: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

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

• Paul Monach, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Lecturer, Staff Physician

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 3, 2019
• Study Start: January 1, 2020
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Protocol will be uploaded when results are reported.

Locations

US (1)