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The Appalachian Tri-State Node Experiences with the National Institute on Drug Abuse Clinical Trials Network

Thomas M Kelly, Dennis C Daley, Mimmie Byrne, Larry DeMarzo, Doris Smith and Stephanie Madl Affiliation: Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania


The National Institute on Drug Abuse (NIDA)-sponsored Clinical Trial Network (CTN) recently celebrated 10 years of conducting ‘‘real world’’ research into the treatment of addiction. This article reviews the history and results of the most recent CTN studies and describes the experiences of one of the 13 participating research affiliates, the Appalachian Tri-State (ATS) Node. We discuss our ‘‘bidirectional’’ collaboration with multiple community treatment programs (CTPs) on research and dissemination activities and include their experiences as a member of our ATS Node. Results of CTN clinical trials have found unexpectedly that treatment as usual (TAU) is often almost as good as evidence-based interventions such as Motivational Interviewing (MI), possibly due to the difficulty in implementing evidence-based practices most effectively among divergent treatment sites and heterogeneous clinical populations. Some expected findings from the reviewed research are that severity of addiction and comorbidity moderate treatment outcomes and must be accounted for in future CTN-sponsored studies. Notwithstanding these results, much has been learned and recommendations are suggested for changes in CTN research designs that will address methodological limitations and increase treatment effectiveness in future CTN studies.

Keywords: clinical trial network, comorbidity, addiction, substance use disorder, treatment

Correspondence: Thomas M. Kelly, Associate Professor of Psychiatry, University of Pittsburgh, School of Medicine, Western Psychiatric Institute and Clinic, 3811 O’Hara St., Pittsburgh, PA 15213. Tel: 412 246 5152; Fax: 412 246 6047; e-mail:

INTRODUCTION Substance use disorders (SUD) are highly prevalent in the

United States and are associated with considerable adverse effects including psychiatric and medical comorbidity and mortality. The National Institute on Drug Abuse (NIDA) reports that drug-related deaths have more than doubled since the early 1980s and one in four deaths in the United States is attributable to alcohol, tobacco, and illicit drug use.1

The Epidemiologic Catchment Area (ECA) study of

20,000adults in five major communities in the United States found that over 13% of adults have an alcohol abuse or dependence disorder and over 6% have a drug abuse or dependence disorder during their lifetime.2 Epidemiologic and clinical studies report high rates of co-occurring psychiatric disorders among individuals with SUDs. For example, the ECA study found that 37% of the community sample meeting criteria for alcohol abuse or dependence and 53% meeting criteria for drug abuse or dependence also met lifetime criteria for a mood, anxiety, psychotic, or personality disorder. The National Comorbidity Study (NCS) found over half of the sample that met criteria for a SUD also met lifetime criteria for a psychiatric disorder.3

Many studies of clinical populations also show high rates of

SUD comorbidity with the highest rates of SUDs among those with antisocial and borderline personality disorders, bipolar disorder, schizophrenia, depressive disorders, and anxiety disorders.2,3 SUDs and co-occurring non-SUD psychiatric

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disorders (CODs) are associated with medical, psychological, social, family, economic, and other problems, causing havoc and suffering for the individual who has the disorder(s) as well as his/her family.411 Furthermore, CODs are associated with higher rates of suicidality, homicidality, and lower rates of treatment adherence compared to individual psychiatric disorders.1221 Given the high rates of SUDs and CODs, mental health professionals need to be familiar with effective clinical interventions because these patients often seek help from all levels of care in psychiatric treatment systems.

Over the past decade, the NIDA-sponsored Clinical Trial Network (CTN) has been working to broaden the scope of treatment of addiction to the mental health and primary health care system and to streamline the research/practice infrastructure in order to reduce the time it takes to implement the most effective clinical interventions in real world treatment settings.

Purpose of This Article

The purpose of this article is to describe strategies used to bridge the gap between research and clinical practice for substance use disorders (SUDs) by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) through the implementation of multi-site clinical trials and dissemina- tion of findings to providers who implement evidence-based practices (EBPs). We provide an overview of the origin, mission, and premises upon which the CTN is based and

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