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Primary outcome issues in drug dependence research

Primary outcome issues in drug dependence research. Presentation overview. D rug abuse treatment outcome research issues NIDA CTN TEAM Task Force formation TEAM Task Force recommendations Implications for treatment and research going forward. State of outcome research.

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Primary outcome issues in drug dependence research

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  1. Primary outcome issues in drug dependence research

  2. Presentation overview • Drug abuse treatment outcome research issues • NIDA CTN TEAM Task Force formation • TEAM Task Force recommendations • Implications for treatment and research going forward

  3. State of outcome research • Lack of consensus about what outcomes are most important • Lack of consensus about how to define efficacy of drug dependence treatment • Lack of consensus on what measures best assess outcomes

  4. TEAM Task Force • Panel of 17 substance abuse treatment and research experts from NIDA’s CTN • Formed in November 2008, with 19 biweekly conference calls and one face-to-face meeting over 11 months.

  5. Results • ctndisseminationlibrary.org/PDF/522.pdf • Donovan, D.M., Bigelow, G.E., Brigham, G.S., Carroll, K.M., Cohen, A.J., Gardin, J.G., Hamilton, J.A., Huestis, M.A., Hughes, J.R., Lindblad, R., Marlatt, G.A., Preston, K.L., Selzer, J.A., Somoza, E.C., Wakim, P.G., Wells, E.A. (2011) Primary outcome indices in illicit drug dependence treatment research: Systematic approach to selection and measurement of drug use endpoints in clinical trials. Addiction, 107(4), 694-708.

  6. TEAM Task Force Goals • To recommend a definition for a clinically meaningful outcome on drug use to be used in CTN clinical trials and a method to capture that outcome. • To develop a set of key questions that would be common across CTN trials

  7. Goal #1 • Primary Outcome: Number of days of drug use during the last 30 days of the active treatment phase • Measured by: Self-report + Biological monitoring • Co-primary Outcome: Consequences of drug use (well being, functioning, satisfaction, QoL)

  8. Assessing drug use

  9. Goal #2 • Timeline Follow-back (TLFB) • Standardized qualitative UDS • Standardized demographic form • ASI Lite • Question on primary drug of use • Question on age of first use • WHO’s BREF instrument

  10. Caveats • There is no single outcome measure recommended for ALL clinical trials • Selection of a primary outcome measure will depend on the study and its goals • Other drugs of use should be assessed • Secondary outcomes should be assessed • Short and long term studies are needed • Research needed examining outcomes in clinical settings

  11. Conclusion and Summary • There is a lack of consensus regarding what to measure and how to measure it in drug treatment research • The TEAM Task Force was given 2 goals, which were achieved • Drug use behavior as primary outcome variable • Using both self-report and toxicology is preferable to either alone • Drug use behavior is complex

  12. John Gardin II, Ph.D.CCO, ADAPT, Inc.Clinical Assistant Professor, OHSU School of Medicinedrjohn@adapt-or.org(541) 672-2691

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