NATIONAL INSTITUTE ON DRUG ABUSE NID A A 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

Drug and Alcohol Dependence 96 (1-2) July 2008, 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 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

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,

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 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,

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

Policies mandate inclusion and analyses of these data Policies mandate inclusion and analyses of these data Researchers usually include participants, but don’t perform valid analyses 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 This article addresses ways to improve these analyses – Measurement – Data analysis Improving Valid Analyses in Ethnic/Race Minorities Burlew et al JSAT 36 (2009) 25-43

Overall Norms Not Appropriate for All Ethnic Subgroups MMPI-2 standardization sample MMPI-2 standardization sample – 993 Non-Hispanic Caucasians (NHCs) – 6 Asian Americans (AAs) Overall mean = (psychasthenia scale) Overall mean = (psychasthenia scale) – for NHCs on pt scale = – for AAs on pt scale = – Raw score of 21 for an AA is considered clinically significant for internal distress Hypothetical example: 993 AAs and 6 NHCs Hypothetical example: 993 AAs and 6 NHCs – Overall mean in this population is – 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 groupDetermine appropriateness for a specific group Evaluate characteristics of the standardization sampleEvaluate characteristics of the standardization sample Examine effects of interviewer/rater race/ethnicityExamine effects of interviewer/rater race/ethnicity Burlew et al JSAT 36 (2009) 25-43

Example: Combining Ethnic Minorities Burlew et al JSAT 36 (2009) Some analyses could be misleading

Recommendations: Data Analysis Sample size is challenging:Sample size is challenging: –Target specific groups –Evaluate effect sizes –Apply statistical techniques for small samples Race-comparison designs may not be optimalRace-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

Need to increase valid analysesNeed to increase valid analyses Need to consider limitations and resources during study designNeed to consider limitations and resources during study design Education:Education: CTN Workshop “Practical Approaches for Valid Subgroup Analysis in the CTN” March 24, 2009 – 1:00-3:30 North Bethesda Marriott Conclusions Burlew et al JSAT 36 (2009) 25-43

Process Improvement: CTN-0030

Anyone responsible for organizing and conducting a multi-site study should have a full understanding of the complexity of the undertaking… — Lawrence Friedman 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 Organizational design of a multi-site trial is as important to its success as is the experimental design. — Curtis Meinert The Importance of Process

SPs: Simulated Patients Actors trained to portray a set of symptoms Actors trained to portray a set of symptoms Widely used Widely used – US medical schools for training/evaluation – Other healthcare training-RNs PharmDs, MSWs – Canada National Medical Licensing Exams – US Medical Licensing Exam Growing trend to help Substance Use clinicians Growing trend to help Substance Use clinicians Clear advantage of using SPs instead of real Pts Clear advantage of using SPs instead of real Pts Limitations: study specific, subjective bias, cost Limitations: study specific, subjective bias, cost

POATS Trial – SPs in Screening/Intake SP trained to emulate patient Construction worker Back Pain Out of Work Prescription Opioid Dependence Screening Visit 1 (research staff) Consent Inclusion/exclusion Locater info Baseline assessments Screening Visit 2 (medical staff) Clinical assessment Lab procedures SP Debrief Both Visits: Admin Research Team Observes & Takes notes

Process Change – POATS Trial Debriefing Topics Scheduling/Organizing Consent Medical/Counselor Interviews Case Report Forms Protocol Flow Participant Comfort Process ChangesAmbianceEnvironmentChecklistsSummariesTraining Time Allotment Extended Hours Calendars

Significance: Innovation in Improving Clinical Trials Process Uses study participant perspective Uses study participant perspective Effective in training research staff Effective in training research staff – Research process – Clinical skills Embraced by the CTN Steering Committee Embraced by the CTN Steering Committee Used in four CTN protocols Used in four CTN protocols Implications for improving recruitment Implications for improving recruitment

CTN-0010

Increased concerns about prescription opioid use Usual Tx for opioid addicted youth: Detox and counseling First RCT of continued agonist Tx in this young population Context

Screening Assent/Consent Both arms received counseling for 12 wks Randomization y/o Opioid addicts (N=152) BUP/NX DETOX over 2 wks Dose Up to 14 mg Treatment and Taper BUP/NX Treatment and Taper for 12 wks Dose up to 24 mg Primary outcome measure (Opioid Positive week 4, 8, and 12 Study Design Woody, G. E. et al. JAMA 2008;300:

Participant Characteristics Participant Characteristics: 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%

Primary Outcome: Opioid Positive Urines 12-Week BUP/NX DETOX Woody, G. E. et al. JAMA 2008;300:

Outcomes 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

Conclusions BUP/NX for 12 weeks is safe in this young population BUP/NX for 12 weeks is safe in this young population Continuing BUP/NX for 12 weeks vs. 2 weeks improved outcome 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 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: