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

Abstract

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.

Keywords:

• alcohol dependence
• cognitive-behavioral therapy
• dual diagnosis
• naltrexone
• psychotherapy research
• posttraumatic stress disorder (PTSD)
• prolonged exposure

Acknowledgments

This study was supported by National Institute on Alcohol Abuse and Alcoholism, Grant 5R01 AA012428. We thank Drs. Don Bux and Joseph Volpichli for their crucial role in developing the grant proposal, Drs. David Riggs and David Yusko for coordination of this complex study, and Michelle Capozzoli and Carly Yasinski for assistance with manuscript preparation.