Alcohol use among adolescents is a major public health concern given its illegal nature in this age group as well as its associated negative psychological, physical, and social consequences. Some surveys indicate that binge drinking (five or more drinks in a row in one sitting) occurs in almost fifty percent (50%) of the adolescents that consume alcohol. Treatment of these adolescents is critical because early intervention may prevent the progression of alcohol dependence into adulthood. Current treatments explored for adolescents are limited to psychosocial treatments; however, the adult alcohol field has explored and is now utilizing pharmacological interventions for alcohol dependence. Recently, the opiate antagonist, naltrexone, has been found to be safe and efficacious in reducing alcohol consumption and craving in adults. This led to the Food and Drug Administration's (FDA) approval of naltrexone for the treatment of alcohol dependence. While naltrexone has been used to treat other child and adolescent disorders, it has not been explored to treat adolescents with alcohol dependence. A few case reports, as well as a small pilot study we conducted, indicate that naltrexone is safe and leads to a reduction in alcohol consumption in adolescents. In order to expand on these preliminary findings, the proposed research is designed to evaluate the efficacy, safety, and tolerability of naltrexone, an opiate antagonist, in the treatment of adolescents with alcohol dependence. The design is a double-blind, placebo-controlled, twelve-week, medication trial with adjunctive, weekly, individual cognitive- behavioral therapy, and with six-month and nine-month follow-ups. A total of 100 male and female adolescent subjects, aged 15 - 18, will be recruited over a four year period for a target sample size of 50 randomized subjects per group. Data from the proposed trial may assist in the development of guidelines for the use of pharmacotherapy in the treatment of adolescents with alcohol dependence.
