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The results of studies of the opiate antagonist naltrexone (NLTX) in the treatment of self-injurious behavior (SIB) in mentally retarded people have been equivocal. They have relied on small patient samples in short-term trials with varying degrees of scientific rigor. Nor has the clinical efficacy of NLTX for SIB been tested against its wider application in nonresearch settings. The present study is a retrospective, long-term study of the clinical use of NLTX for SIB, drawn from clinical experience in the entire population of the state schools of Texas (population = 8,000). More than 50% of the 56 SIB individuals treated with NLTX were maintained on the drug by virtue of clinical benefit perceived by treating professionals; 25% of the 56 individuals could be classified as unequivocal responders based upon strict objective response criteria. Variables associated with positive response were level of disability and lack of concurrent aggression. Unexpectedly, all of the objective responders displayed a gradual and continuous decrease in SIB over time, even after 3 years of treatment. (J Clin Psychopharmacol 1996;16:389-394).