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Studies designed to investigate the use of oral steroids in the setting of acute low back pain are limitedby the high prevalence of steroid use among patients with acute lower back pain. There is little clinical evidence that oral steroids can induce or persist chronic low back pain.
OBJECTIVES:
To describe the pharmacokinetics of naltrexone hydrochloride in a controlled and open-label, single-dose study.
DESIGN:
Single-dose, open-label, single-pharmacology, unblinded, multicenter, dose-response study.
SETTING:
Inpatient or outpatient clinic.
PATIENTS:
Nine patients with naltrexone Hydrochloride (600 mg IV or 600 g IV) administration in a 24-hour period.
INTERVENTIONS:
Eight patients received a single treatment session, each lasting for an hour and a half, of the lowest effective dose of naltrexone hydrochloride (0.4 g/kg).
MAIN OUTCOME MEASURES:
Clinical assessments, measures of drug effects and adverse effects and end-of-treatment plasma levels of naltrexone hydroxide.
RESULTS:
All patients completed the study. Pharmacokinetic analysis demonstrated that naltrexone was highly effective in the treatment of acute lower back pain and was well tolerated. Plasma naltrexone hydroxide levels were undetectable before and after treatment in all patients. A single oral infusion of the lowest effective naltrexone dose (0.4 g/kg) significantly improved all clinical measures and was dose-dependent. Most patients did not require additional intravenous dosing to maintain plasma levels above the therapeutic range.
CONCLUSIONS:
Naltrexone hydrochloride provides a safe and effective treatment for acute low-back pain. It is well tolerated and does not require additional dosing to be maintained. In a short-term study, naltrexone was well-tolerated and does not require additional dosing to maintain plasma levels above normal ranges.
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