NATIONAL

INSTITUTE ON DRUG

ABUSE

NATIONAL

INSTITUTE ON DRUG

ABUSENIDNIDAARecent Scientific and Process Publications Recent Scientific and Process Publications

from the Clinical Trials Networkfrom the Clinical Trials Network

Betty Tai, Ph.D.Betty Tai, Ph.D.Harold Perl, Ph.D. (CTN-0004)Harold Perl, Ph.D. (CTN-0004)

Carmen Rosa, M.S. (Valid Subgroup Analyses)Carmen Rosa, M.S. (Valid Subgroup Analyses)Carol Cushing, B.B.A., R.N. (CTN-0030)Carol Cushing, B.B.A., R.N. (CTN-0030)

Petra Jacobs, M.D. (CTN-0010)Petra Jacobs, M.D. (CTN-0010)

Measuring Therapist Skills in Delivering Evidence Based Treatment

Drug and Alcohol Dependence 96 (1-2) July 2008, 37- 48

Treatment Fidelity is Critical Issuein 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, 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 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 Valid Analysis to Address Health Disparities in Substance AbuseDisparities in Substance Abuse

• Policies mandate inclusion and analyses of these Policies mandate inclusion and analyses of these data data

• Researchers usually include participants, but don’t Researchers usually include participants, but don’t perform valid analysesperform valid analyses– Measures and analytic strategies may not apply equally for Measures and analytic strategies may not apply equally for

all groupsall groups

• This article addresses ways to improve these This article addresses ways to improve these analyses analyses – MeasurementMeasurement– Data analysisData analysis

Improving Valid Analyses in Improving Valid Analyses in Ethnic/Race MinoritiesEthnic/Race Minorities

Burlew et al JSAT 36 (2009) 25-43

Overall Norms Not Appropriate Overall Norms Not Appropriate for All Ethnic Subgroupsfor All Ethnic Subgroups

• MMPI-2 standardization sample MMPI-2 standardization sample – 993 Non-Hispanic Caucasians (NHCs)993 Non-Hispanic Caucasians (NHCs)– 6 Asian Americans (AAs)6 Asian Americans (AAs)

• Overall mean = 11.06 (psychasthenia scale)Overall mean = 11.06 (psychasthenia scale)– for NHCs on pt scale = 11.04 for NHCs on pt scale = 11.04 – for AAs on pt scale = 14.33for AAs on pt scale = 14.33– Raw score of 21 for an AA is considered clinically Raw score of 21 for an AA is considered clinically

significant for internal distresssignificant for internal distress

• Hypothetical example: 993 AAs and 6 NHCsHypothetical example: 993 AAs and 6 NHCs– Overall mean in this population is 14.30Overall mean in this population is 14.30– Raw score of 21 now would be in normal rangeRaw score of 21 now would be in normal range

Burlew et al JSAT 36 (2009) 25-43

Recommendations: MeasuresRecommendations: Measures

• Determine appropriateness for a Determine appropriateness for a specific groupspecific group

• Evaluate characteristics of the Evaluate characteristics of the standardization samplestandardization sample

• Examine effects of interviewer/rater Examine effects of interviewer/rater race/ethnicityrace/ethnicity

Burlew et al JSAT 36 (2009) 25-43

Example: Combining Ethnic MinoritiesExample: Combining Ethnic Minorities

Burlew et al JSAT 36 (2009) 25-43

Some analyses could be misleading

Recommendations: Data AnalysisRecommendations: Data Analysis

• Sample size is challenging:Sample size is challenging:– Target specific groupsTarget specific groups– Evaluate effect sizesEvaluate effect sizes– Apply statistical techniques for small samplesApply statistical techniques for small samples

• Race-comparison designs may not be Race-comparison designs may not be optimaloptimal– Conduct within-group or between-groups Conduct within-group or between-groups

analyses analyses – Look at engagement or retention insteadLook 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 Need to consider limitations and

resources during study designresources during study design• Education:Education:

CTN WorkshopCTN Workshop““Practical Approaches for Practical Approaches for

Valid Subgroup Analysis in the CTN”Valid Subgroup Analysis in the CTN”

March 24, 2009 – 1:00-3:30 pm @ North Bethesda March 24, 2009 – 1:00-3:30 pm @ North Bethesda MarriottMarriott

ConclusionsConclusions

Burlew et al JSAT 36 (2009) 25-43

Process Improvement: CTN-0030Process 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 ProcessThe Importance of ProcessThe Importance of ProcessThe Importance of Process

SPs: Simulated PatientsSPs: Simulated Patients

• Actors trained to portray a set of sActors trained to portray a set of symptomsymptoms• Widely used Widely used

– US medical schools for training/evaluation US medical schools for training/evaluation – Other healthcare training-RNs PharmDs, MSWsOther healthcare training-RNs PharmDs, MSWs– Canada National Medical Licensing ExamsCanada National Medical Licensing Exams

– US Medical Licensing ExamUS Medical Licensing Exam

• Growing trend to help Substance Use cliniciansGrowing trend to help Substance Use clinicians

• Clear advantage of using SPs instead of real PtsClear advantage of using SPs instead of real Pts

• Limitations: study specific, subjective bias, costLimitations: study specific, subjective bias, cost

POATS Trial POATS Trial – – SPs in Screening/IntakeSPs 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

SP Debrief

Both Visits:Admin ResearchTeam Observes & Takes notes

Process Change – POATS TrialProcess Change – POATS Trial

Debriefing TopicsDebriefing TopicsScheduling/Organizing

ConsentMedical/Counselor Interviews

Case Report FormsProtocol Flow

Participant Comfort

Process ChangesAmbianceAmbiance

EnvironmentEnvironmentChecklistsChecklistsSummariesSummaries

TrainingTrainingTime AllotmentTime AllotmentExtended HoursExtended Hours

CalendarsCalendars

Significance: Innovation in Significance: Innovation in Improving Clinical Trials ProcessImproving Clinical Trials Process

• Uses study participant perspectiveUses study participant perspective• Effective in training research staffEffective in training research staff

–Research processResearch process–Clinical skillsClinical skills

• Embraced by the CTN Steering CommitteeEmbraced by the CTN Steering Committee• Used in four CTN protocolsUsed in four CTN protocols• Implications for improving recruitmentImplications for improving recruitment

CTN-0010CTN-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 Both arms received counseling for 12 wkscounseling for 12 wks

Randomization15-21 y/o

Opioid addicts (N=152)

BUP/NX DETOX over 2 wks

Dose Up to 14 mg

BUP/NX Treatment Treatment and Taperand Taper for 12 wks

Dose up to 24 mg

Primary outcome measure (Opioid Positive Urine)

@ week 4, 8, and 12

Study DesignStudy Design

Woody, G. E. et al. JAMA 2008;300:2003-2011.

Woody, G. E. et al. JAMA 2008;300:2003-2011.

Participant CharacteristicsParticipant CharacteristicsParticipant 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: Primary Outcome: Opioid Positive UrinesOpioid Positive Urines

12-Week BUP/NXDETOX

Woody, G. E. et al. JAMA 2008;300:2003-2011.

Woody, G. E. et al. JAMA 2008;300:2003-2011.

Secondary OutcomesOutcomes

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

ConclusionsConclusions

• BUP/NX for 12 weeks is safe in this BUP/NX for 12 weeks is safe in this young populationyoung population

• Continuing BUP/NX for 12 weeks vs. 2 Continuing BUP/NX for 12 weeks vs. 2 weeks improved outcome weeks improved outcome

• Research on long term treatment and Research on long term treatment and follow-up in this population might be a follow-up in this population might be a good next studygood next study

Woody, G. E. et al. JAMA 2008;300:2003-2011.