Transcript CTN-0010 - CTN Dissemination Library

NIDA
NATIONAL INSTITUTE
ON DRUG ABUSE
Recent Scientific and Process Publications
from the Clinical Trials Network
Betty Tai, Ph.D.
Harold Perl, Ph.D. (CTN-0004)
Carmen Rosa, M.S. (Valid Subgroup Analyses)
Carol Cushing, B.B.A., R.N. (CTN-0030)
Petra Jacobs, M.D. (CTN-0010)
Measuring Therapist Skills in
Delivering Evidence Based Treatment
Treatment Fidelity is Critical Issue
in Adopting EBTs
• MET increases treatment engagement
and reduces later substance use
– MET is manual-based adaptation of MI
• Little research on whether community
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therapists can implement MET with skill
Few practical tools to evaluate fidelity
of real-world treatment
New rating scale measures therapist
adherence and competence in MET
Drug and Alcohol Dependence 96 (1-2) July 2008, 37- 48
Independent Tape Rater Scale
• Audiotapes of CTN-0004 sessions
– 15 raters; 35 therapists; 5 outpatient programs
– Psychometrically sound
– Assesses practices that are consistent or
inconsistent with model
– Measures frequency and appropriateness of
therapist practices
• 2-factor scale reliably distinguished
MET and TAU therapists
– Fundamental MI skills
– Advanced MI skills
Drug and Alcohol Dependence 96 (1-2) July 2008, 37- 48
Better MET Skills Lead to Better
Clinical Outcomes
• When therapists use MI skills more often
and more competently
– Clients express increased motivation to reduce or stop
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substance use
(competent use of fundamental skills: r = .22, p < .001)
Clients present more negative drug screens during
4-week treatment phase
(frequent use of advanced skills: r = .21, p < .001)
• Expert training and in-clinic supervision &
coaching increases therapist skill
Drug and Alcohol Dependence 96 (1-2) July 2008, 37- 48
Findings Utilized as Core of
NIDA Blending Product
• Many State AOD
Directors now
funding clinical
supervision
• Research
instrument now
being used as
clinical tool
Valid Analysis to Address Health
Disparities in Substance Abuse
Improving Valid Analyses in
Ethnic/Race Minorities
• Policies mandate inclusion and analyses
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of these data
Researchers usually include participants,
but don’t perform valid analyses
– Measures and analytic strategies may not
apply equally for all groups
• This article addresses ways to improve
these analyses
– Measurement
– Data analysis
Burlew et al JSAT 36 (2009) 25-43
Overall Norms Not Appropriate
for All Ethnic Subgroups
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MMPI-2 standardization sample
– 993 Non-Hispanic Caucasians (NHCs)
– 6 Asian Americans (AAs)
• Overall mean = 11.06 (psychasthenia scale)
– for NHCs on pt scale = 11.04
– for AAs on pt scale = 14.33
– Raw score of 21 for an AA is considered clinically
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significant for internal distress
Hypothetical example: 993 AAs and 6 NHCs
– Overall mean in this population is 14.30
– Raw score of 21 now would be in normal range
Burlew et al JSAT 36 (2009) 25-43
Recommendations: Measures
• Determine appropriateness for a
specific group
• Evaluate characteristics of the
standardization sample
• Examine effects of interviewer/rater
race/ethnicity
Burlew et al JSAT 36 (2009) 25-43
Example: Combining Ethnic Minorities
Some analyses could be misleading
Burlew et al JSAT 36 (2009) 25-43
Recommendations: Data Analysis
• Sample size is challenging:
– Target specific groups
– Evaluate effect sizes
– Apply statistical techniques for small samples
• Race-comparison designs may not be
optimal
– Conduct within-group or between-groups
analyses
– Look at engagement or retention instead
Burlew et al JSAT 36 (2009) 25-43
Conclusions
• Need to increase valid analyses
• Need to consider limitations and
resources during study design
• Education:
CTN Workshop
“Practical Approaches for
Valid Subgroup Analysis in the CTN”
March 24, 2009 – 1:00-3:30 pm @ North Bethesda
Marriott
Burlew et al JSAT 36 (2009) 25-43
Process Improvement: CTN-0030
The Importance of Process
Anyone responsible for organizing and
conducting a multi-site study should have a full
understanding of the complexity of the
undertaking…
— Lawrence Friedman
Organizational design of a multi-site trial is as
important to its success as is the experimental
design.
— Curtis Meinert
SPs: Simulated Patients
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Actors trained to portray a set of symptoms
Widely used
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Growing trend to help Substance Use clinicians
Clear advantage of using SPs instead of real Pts
Limitations: study specific, subjective bias, cost
– US medical schools for training/evaluation
– Other healthcare training-RNs PharmDs, MSWs
– Canada National Medical Licensing Exams
– US Medical Licensing Exam
POATS Trial –
SPs in Screening/Intake
SP trained to emulate patient
• Construction worker
• Back Pain
• Out of Work
• Prescription Opioid Dependence
Both Visits:
Admin
Research
Team
Observes
&
Takes
notes
Screening Visit 1
(research staff)
• Consent
• Inclusion/exclusion
• Locater info
• Baseline assessments
SP Debrief
Screening Visit 2
(medical staff)
• Clinical assessment
• Lab procedures
SP Debrief
Process Change – POATS Trial
Debriefing Topics
Scheduling/Organizing
Consent
Medical/Counselor Interviews
Case Report Forms
Protocol Flow
Participant Comfort
Process Changes
Ambiance
Environment
Checklists
Summaries
Training
Time Allotment
Extended Hours
Calendars
Significance: Innovation in
Improving Clinical Trials Process
• Uses study participant perspective
• Effective in training research staff
– Research process
– Clinical skills
• Embraced by the CTN Steering Committee
• Used in four CTN protocols
• Implications for improving recruitment
CTN-0010
Context
• Increased concerns about prescription
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opioid use
Usual Tx for opioid addicted youth:
Detox and counseling
First RCT of continued agonist Tx in
this young population
Study Design
Screening Assent/Consent
Randomization
15-21 y/o
Opioid addicts
(N=152)
BUP/NX DETOX
over 2 wks
Dose Up to 14 mg
Both arms received
counseling for 12 wks
Treatment
and Taper for 12 wks
BUP/NX
Dose up to 24 mg
Primary outcome measure
(Opioid Positive Urine)
@ week 4, 8, and 12
Woody, G. E. et al. JAMA 2008;300:2003-2011.
Participant Characteristics
Participant Characteristics:
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Mean age: 19
Race/ethnicity:
–White: 73%
–Hispanic: 25%
Main problem
–Heroin: 55%
–Opioid analgesics: 34%
Median opioid use: 1 year
Injecting: 48%
Positive for hepatitis C: 18%
Woody, G. E. et al. JAMA 2008;300:2003-2011.
Primary Outcome:
Opioid Positive Urines
12-Week BUP/NX
DETOX
Woody, G. E. et al. JAMA 2008;300:2003-2011.
Secondary Outcomes
During weeks 1-12, pts on 12 wks
BUP/NX vs. 2 wks had:
• better retention (p<.001): 70% vs. 21%
• less injecting (p=.01)
• less reported use of cocaine (p<.001),
marijuana (p<.001)
• no SAE resulting from BUP/NX
Woody, G. E. et al. JAMA 2008;300:2003-2011.
Conclusions
• BUP/NX for 12 weeks is safe in this
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young population
Continuing BUP/NX for 12 weeks vs. 2
weeks improved outcome
Research on long term treatment and
follow-up in this population might be a
good next study
Woody, G. E. et al. JAMA 2008;300:2003-2011.