Methodology of a randomized double-blind clinical trial for comorbid posttraumatic stress disorder and alcohol dependence.

INTRODUCTION: Alcohol dependence (AD) and posttraumatic stress disorder (PTSD) are each associated with profound disruptions in psychological, social, and physical functioning, and these disruptions are compounded in individuals with both disorders. Comorbidity between the two disorders is high, with the risk for AD increasing substantially among individuals with PTSD and, conversely, PTSD is highly prevalent among people experiencing AD. AIMS: Given the increased impairment associated with this comorbidity, it is imperative to develop effective treatments for individuals who experience both disorders. METHODS: This paper describes the methodology of a study that examines the efficacy of prolonged exposure therapy alone, naltrexone alone, and their combination compared to pill placebo in reducing the severity of PTSD and alcohol use in individuals with comorbid AD and PTSD. DISCUSSION: Issues related to design, assessment, treatment choice, and challenges posed by the study population are discussed.