Clinical Trials for Alcohol Dependence: The Alcohol Clinical Trials Initiative (ACTIVE) and Beyond

Chairs: Nina R. Schooler, PhD; Raymond F. Anton, Jr. MD
 
Speakers include:
 Raymond F. Anton, Jr. MD, Medical University of South Carolina
 Karl Broich, MD, BfArM
 Raye Litten, PhD, National Institute on Alcohol Abuse and Alcoholism
 Roger Meyer, MD, Best Practice Project Management, Inc.
 Joe Palumbo, MD, Johnson & Johnson Pharmaceuticals
 Celia Winchell, MD, US Federal Drug Administration
LINK TOProgram Agenda

ABSTRACT: The American College of Neuropsychopharmacology (ACNP) ACTIVE initiative is in remarkable harmony with the goals of ISCTM. A consortium was developed that included academia and representatives from the FDA, NIAAA, and the pharmaceutical industry to work together to identify and clarify clinical trials methodology to evaluate medications to treat alcohol dependence. 

ACTIVE has been addressing a number of questions that are critical for studies of medications to treat alcohol dependence. These include the drinking outcomes that are meaningful and acceptable to all parties, including practitioners, the definition of a “treatment responder,” how to handle missing data in clinical trials, the role of patient self-reported outcomes, and the need for biological markers of drinking and treatment response. Of particular importance, the group has adopted a data-driven approach to many of these questions and shared data from development programs that have been made available to ACTIVE for analysis such as:  Questions regarding optimal trial length and definition of a primary outcome measure?; What is the optimal outcome measure for such trials and would acceptance of a new measure lead to greater activity in the area.

The goals of the session are:
1.    To inform ISCTM about the work of the ACTIVE consortium
2.    To advance understanding of epidemiology of alcohol dependence
      and clinical trial outcome measures
3.    To develop strategies for incorporating the alcohol
       clinical trial investigators in ISCTM activities
4.    To understand the reasons for limited industry
       activity in alcohol dependence