A double blind placebo controlled clinical trial is proposed to evaluate the efficacy of naltrexone in the treatment of alcoholic women with and without eating disturbances. Although naltrexone, an opioid antagonist, has been found to be effective in the treatment of alcoholic men, the efficacy of naltrexone has not been established in women. In addition, alcoholic women present with a unique set of problems including high rates of disordered eating. Based on research demonstrating that opioid antagonists reduce the frequency of binging in nonalcoholic women with eating disturbances and alter preferences for sweet and fatty foods, we hypothesize that naltrexone may have an added benefit on regulation of eating behavior for alcoholic women with concurrent eating disturbances. In the study design, 60 alcoholic women with and 60 alcoholic women without eating disturbances will be randomly assigned to placebo or naltrexone treatment along with coping skills/relapse prevention group psychotherapy for 12 weeks. The following specific aims will be addressed in the proposed research: (1) to evaluate the efficacy of naltrexone in alcoholic women with and without eating disturbances on alcohol consumption, craving, psychiatric symptoms, and alcohol related social and occupational problems; (2) to evaluate the effect of naltrexone on the dietary intake and eating behavior of alcoholic women with and without eating disturbances; (3) to examine six-month posttreatment follow-up status for enduring and delayed treatment effects; and (4) to assess pretreatment patient characteristics (e.g., severity of alcohol dependence, family history, psychiatric symptomatology, and social functioning) as predictors of responsiveness to treatment. If our hypotheses are confirmed, the study will provide critical information regarding naltrexone's effectiveness in treating alcoholism in women while also providing information on its potential value in addressing eating disturbances that are common among alcoholic women.
| O'Malley, Stephanie S; Sinha, Rajita; Grilo, Carlos M et al. (2007) Naltrexone and cognitive behavioral coping skills therapy for the treatment of alcohol drinking and eating disorder features in alcohol-dependent women: a randomized controlled trial. Alcohol Clin Exp Res 31:625-34 |
| Gueorguieva, Ralitza; Wu, Ran; Pittman, Brian et al. (2007) New insights into the efficacy of naltrexone based on trajectory-based reanalyses of two negative clinical trials. Biol Psychiatry 61:1290-5 |
| Sinha, R; O'Malley, S S (2000) Alcohol and eating disorders: implications for alcohol treatment and health services research. Alcohol Clin Exp Res 24:1312-9 |
