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In this replication and extension study of a previous clinical trial, we tested the impact of low\u2010dose naltrexone on daily self\u2010reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Thirty\u2010one women with fibromyalgia participated in the randomized, double\u2010blind, placebo\u2010controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low\u2010dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; <jats:italic>P<\/jats:italic> = 0.016). Low\u2010dose naltrexone was also associated with improved general satisfaction with life (<jats:italic>P<\/jats:italic> = 0.045) and with improved mood (<jats:italic>P<\/jats:italic> = 0.039), but not improved fatigue or sleep. Thirty\u2010two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low\u2010dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (<jats:italic>P<\/jats:italic> = 0.05). Low\u2010dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The preliminary evidence continues to show that low\u2010dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well\u2010tolerated. Parallel\u2010group randomized controlled trials are needed to fully determine the efficacy of the medication.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.37734","type":"journal-article","created":{"date-parts":[[2013,1,28]],"date-time":"2013-01-28T23:47:04Z","timestamp":1359416824000},"page":"529-538","source":"Crossref","is-referenced-by-count":188,"title":["Low\u2010dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double\u2010blind, placebo\u2010controlled, counterbalanced, crossover trial assessing daily pain 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