Naltrexone for Chronic Back Pain
Naltrexone is NOT recommended as a treatment for chronic back pain based on current clinical practice guidelines, which do not include it in any treatment algorithm for this condition. 1
Why Naltrexone Is Not Appropriate for Back Pain
Standard naltrexone (50 mg) is an opioid antagonist FDA-approved exclusively for opioid use disorder and alcohol use disorder—not for pain management. 2 Its mechanism of action directly contradicts pain treatment: it blocks opioid receptors, which would actually prevent pain relief from any opioid medications and could precipitate severe withdrawal in patients with opioid dependence. 2
Critical Safety Concerns
- Naltrexone precipitates severe withdrawal in opioid-dependent patients, requiring a minimum 7-10 day opioid-free period before initiation (up to 2 weeks for buprenorphine or methadone). 2
- If your patient has any history of opioid use or is currently taking opioids for pain, naltrexone is absolutely contraindicated and could cause life-threatening withdrawal symptoms. 2
- The FDA label contains no indication, dosing guidance, or safety data for pain management. 2
What About Low-Dose Naltrexone?
Low-dose naltrexone (1-4.5 mg daily) is an entirely off-label use with insufficient evidence to support its use for chronic back pain:
- The most recent high-quality study (2025) showed only a -0.83 point reduction in pain scores on average, which is clinically insignificant. 3
- A 2024 observational study found highly variable individual responses requiring idiosyncratic dose titration (0.1-4.5 mg), making standardized treatment impossible. 4
- No clinical practice guidelines from the American College of Physicians, American Pain Society, or HIVMA/IDSA mention low-dose naltrexone as a treatment option for back pain. 1
- The 2018 systematic review concluded that "further randomized controlled trials are needed to determine the efficacy of low-dose naltrexone due to insufficient evidence." 5
Evidence-Based Treatment Algorithm for Chronic Back Pain
First-line therapy: Acetaminophen or NSAIDs (ibuprofen, naproxen) are recommended as initial pharmacologic treatment. 1, 6
- Acetaminophen offers a favorable safety profile but weaker analgesic effect. 1, 6
- NSAIDs provide stronger pain relief but carry gastrointestinal and cardiovascular risks. 1, 6
Second-line therapy: If first-line agents fail and pain remains moderate-to-severe with functional impairment, consider tramadol or duloxetine. 1, 6
- Tramadol provides approximately 1-point improvement on a 0-10 pain scale with modest functional benefits. 6
- For radicular pain, tricyclic antidepressants, duloxetine, or gabapentin may be added. 7, 6
Third-line therapy: Opioids should only be considered after failure of all other treatments, in appropriately selected patients, with careful risk-benefit discussion. 1
- Reserve opioids exclusively for severe, disabling pain uncontrolled by other measures. 7
- Use the lowest effective dose for the shortest duration. 1, 7
- Implement routine monitoring with patient-provider agreements and urine drug testing. 1
Nonpharmacologic approaches should be prioritized: exercise, multidisciplinary rehabilitation, acupuncture, cognitive behavioral therapy, and spinal manipulation all have evidence supporting their use. 1
Common Pitfalls to Avoid
- Do not confuse standard-dose naltrexone (opioid antagonist) with low-dose naltrexone (experimental pain treatment)—they have completely different mechanisms and indications. 2, 8
- Never prescribe naltrexone to any patient currently taking or recently exposed to opioids without ensuring adequate opioid-free interval and negative naloxone challenge. 2
- Do not use low-dose naltrexone as anything other than a last-resort experimental option after exhausting all guideline-recommended therapies, and only with informed consent about the lack of evidence. 3, 5
- The one study showing benefit for an oxycodone-naltrexone combination formulation (ALO-02) is irrelevant to your question—it used naltrexone solely as an abuse-deterrent mechanism, not as an analgesic. 9