Naltrexone in the treatment of alcoholism.

Alcoholism affects nearly 12.5 million Americans and is responsible for annual costs of over $130 billion from loss of job productivity, deleterious health effects, and direct treatment expenses. Research on treating alcoholism from the standpoint of relapse prevention using psychosocial interventions alone has produced only modest results. Studies on the efficacy of adjunctive medications using multiple medications in placebo-controlled and open trials combined with psychosocial interventions have shown mixed results. Recently, a safe and well-tolerated opiate antagonist, naltrexone, was approved by the Food and Drug Administration (FDA) for the adjunctive treatment of alcoholism. This review describes the pertinent preclinical and clinical research that led to the FDA's approval. Details are provided describing the subjects, methods, and results of the two pivotal human studies that led to the FDA review for this indication. Clinical therapeutic guidelines, appropriate patient selection, and future directions are also elucidated.