NALTREXONE IN THE TREATMENT OF ALCOHOLISM

Alcoholism affects nearly 12.5 million Americans and is responsible fo r annual costs of over $130 billion from loss of job productivity, del eterious health effects, and direct treatment expenses. Research on tr eating alcoholism from the standpoint of relapse prevention using psyc hosocial 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 inter ventions have shown mixed results. Recently, a safe and well-tolerated opiate antagonist, naltrexone, was approved by the Food and Drug Admi nistration (FDA) for the adjunctive treatment of alcoholism. This revi ew describes the pertinent preclinical and clinical research that led to the FDA's approval. Details are provided describing the subjects, m ethods, and results of the two pivotal human studies that led to the F DA review for this indication. Clinical therapeutic guidelines, approp riate patient selection, and future directions are also elucidated.