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Primary outcome issues in drug dependence
research
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
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
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-toface meeting over 11 months.
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.
TEAM Task Force Goals
1. 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.
2. To develop a set of key questions that
would be common across CTN trials
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)
Assessing drug use
Method
Strengths
Limitations
Self-report
Convenient, inexpensive
Uncertain validity
Temporal/quant detail
Distortion possible
Missing data retrievable
Standardization
Objective data
Inconvenient/expensive
Adequate specimen amnt
Variable detection
windows
On-site/lab availability
Collection issues
Toxicology
Poor sensitivity to less use
Missing data lost
Goal #2
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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
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
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
John Gardin II, Ph.D.
CCO, ADAPT, Inc.
Clinical Assistant Professor, OHSU School of Medicine
[email protected]
(541) 672-2691