Skip Navigation

Link to  the National Institutes of Health  
The Science of Drug Abuse and Addiction from the National Institute on Drug Abuse Archives of the National Institute on Drug Abuse web site
Go to the Home page

NIDA Home > Past Scientific Meetings    

Clinically Meaningful Substance Abuse Treatment
Outcome for Effectiveness Trials

NIDA Science Meeting
Bethesda, MD
December 15-16, 2009


Carmen L. Rosa, M.S.
Center for the Clinical Trials Network
National Institute on Drug Abuse
(301) 443-9830

Paul G. Wakim, PhD
Center for the Clinical Trials Network
National Institute on Drug Abuse
(301) 402-3057

Jack Blaine, PhD
Center for the Clinical Trials Network
National Institute on Drug Abuse
(301) 443-2246

View Agenda (PDF - 45 Kb)

Main Objectives

  • What is a clinically meaningful and scientifically valid primary outcome for effectiveness trials on substance abuse treatments?
  • What is the most appropriate approach (e.g. instrument, algorithm, or procedure) for capturing that outcome?

Expectation from Meeting

To reach a consensus on:

  • What we know today, and therefore what doesn't need to be re-addressed.
  • The key issues needed to fill important gaps in our scientific knowledge.

Why is this important?

  • So that we collect and analyze data on clinically meaningful outcomes at critical time points in the most cost-effective manner
  • So that we compare treatment effectiveness across trials based on a common scale
  • So that we conduct secondary analyses across trials based on common elements
  • So that we don't revisit the same issues over and over again every time we design a new trial

Two Different Harmonization Issues

  • (Drug abuse) Science harmonization, the focus of this NIDA Science Meeting
  • Operational harmonization, i.e. standardization of instruments, questionnaires, case report forms, etc.


  • Introduction
  • Alcohol Experience
  • Tobacco Experience
  • Mental Health (Depression) Experience
  • History of Outcomes in Substance Abuse Effectiveness Trials
  • Panel I: State of the Science in Assessing Drug Use in Clinical Research: Biological Measures
  • Panel II: State of the Science in Assessing Drug Use in Clinical Research: Self-Reported Measures
  • Panel III: Primary Outcome
  • Panel IV: Other Important Measures to Consider

Meeting Consensus

  • Different studies with different goals, treatment aims, and target populations necessitate different outcomes.
  • Drug use, measured by self-report and biological test, is one strong candidate for primary outcome.
  • But consequences of drug use, e.g. psychosocial functioning, quality of life, criminal justice involvement, may also be as important.

Moving Forward

  • "Operational harmonization" helps "science harmonization" by evaluating assessment tools across studies
  • Conduct long-term follow-up studies to identify short-term predictors of long-term outcomes, and to better understand which are important
  • Analyze CTN data currently on CTN's Public Data Share (22 studies) based on common instruments
  • Plan another workshop in 2-3 years, but with results from analyses
website graphic for NIH meeting - New Models for Large Prospective Studies Symposium

How Should NIH Approach Future Prospective Cohort Studies

  • Ensure future studies, including disease-specific studies, address widest possible range of outcomes
  • Strong leadership is essential
  • Use standardized measures to permit diverse studies to be combined (and that could start NOW)
  • Establish consents that allow for broad research use and data sharing
  • Maximize cost-efficiency where appropriate by:
    • Exploring centralized recruitment and exam models
    • Considering lower recruitment yield if associations rather than prevalence are primary objective
    • Utilizing electronic records

What's New Contents

Archive Home | Accessibility | Privacy | FOIA (NIH) | Current NIDA Home Page
National Institutes of Health logo_Department of Health and Human Services Logo The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH) , a component of the U.S. Department of Health and Human Services. Questions? See our Contact Information. . The U.S. government's official web portal