NATIONAL

INSTITUTE ON DRUG

ABUSE

NATIONAL

INSTITUTE ON DRUG

ABUSENIDNIDAARecent Scientific Findings from Recent Scientific Findings from

The Clinical Trials NetworkThe Clinical Trials Network

Betty Tai, Ph.D.Betty Tai, Ph.D.

Steven Sparenborg, Ph.D. (CTN-0009)Steven Sparenborg, Ph.D. (CTN-0009)

Petra Jacobs, M.D. (CTN-0013)Petra Jacobs, M.D. (CTN-0013)

RaRaúúl Mandler, M.D. (CTN-0019)l Mandler, M.D. (CTN-0019)

Paul Wakim, Ph.D. (Secondary Analysis)Paul Wakim, Ph.D. (Secondary Analysis)

Smoking Cessation Treatment in Community-Smoking Cessation Treatment in Community-based Substance Abuse Rehabilitation Programsbased Substance Abuse Rehabilitation Programs

Malcolm S. Reid, Bryan Fallon, Susan Sonne, Frank Flammino, Edward V. Nuñes, Huiping Jiang,

Eva Kourniotis, Jennifer Lima, Ron Brady, Cynthia Burgess, Cynthia Arfken, Eric Pihlgren, Louis Giordano, Aron Starosta, James Robinson, John Rotrosen

Journal of Substance Abuse Treatment 2008 35(1): 68–77

Study FlowStudy Flow

225 participants expressing desire to quit smoking randomized at 5 methadone and 2 drug and alcohol abuse

clinics

Smoking Cessation (9 group sessions & patch)

+ Substance Abuse TAU

N = 153

Substance Abuse TAU

+Post FU SC (offered)

N = 72

Completers

N = 68

Completers

N = 142

2:1

CTN-0009

Smoking Cessation in Outpatient Treatment

• SC treatment reduced:

– number of cigarettes smoked

– breath CO levels

– craving

CTN-0009

Smoking Cessation in Outpatient Treatment

• Concurrent Concurrent SC and AoD SC and AoD dependence dependence treatment treatment does not does not worsen AoD worsen AoD treatment treatment outcomesoutcomes

CTN-0009

Motivational Enhancement Therapy to Improve Treatment Utilization and Outcome

in Pregnant Substance Users

Winhusen T, Kropp F, Babcock D, Hague D,Erickson SJ, Renz C, Rau L, Lewis D,

Leimberger J, Somoza E.

Journal of Substance Abuse Treatment 2008 35(2):161-73

Motivational Enhancement Therapy to Improve Treatment Utilization and Outcome

in Pregnant Substance Users

• Brief motivational interventions increase treatment engagement and improve outcomes in alcohol and drug abusing populations

• CTN-0013 randomized clinical trial: Evaluate the efficacy of 3-session Motivational Enhancement Therapy (MET), compared to treatment as usual (TAU), in increasing treatment utilization and decreasing substance use in pregnant substance users

CTN-0013

Motivational Enhancement Therapy to Improve Treatment Utilization and Outcome

in Pregnant Substance Users

• Largest randomized clinical trial (n = 200, at 4 sites) with pregnant substance users

• Primary outcome (treatment utilization): No differences between groups; 62% on average

Trial Week

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16M

ean

Pro

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0%

10%

20%

30%

40%

50%

MET TAU

• Self-reported days of drug/ alcohol use: No differences between groups; significant decrease during first treatment month (Z=-2.40, p<.05)CTN-0013

HIV/STD Safer Skills Groups for Women in HIV/STD Safer Skills Groups for Women in Methadone Maintenance or Psychosocial Methadone Maintenance or Psychosocial

Outpatient TreatmentOutpatient Treatment

Effectiveness of HIV/STD Sexual Risk Reduction Groups Effectiveness of HIV/STD Sexual Risk Reduction Groups For Women In Substance Abuse Treatment Programs: For Women In Substance Abuse Treatment Programs:

Results Of NIDA Clinical Trials Network TrialResults Of NIDA Clinical Trials Network Trial

Susan Tross, Aimee Campbell, Lisa Cohen, Donald Calsyn, Martina Pavlicova, Gloria Miele, Mei-Chen Hu, Louise Haynes,

Nancy Nugent, Weijin Gan, Mary Hatch-Maillette, Raúl Mandler, Paul McLaughlin, Nabila El-Bassel,

Paul Crits-Cristoph, Edward Nuñes

Journal of Acquired Immune Deficiency Syndromes 200848(5): 581-589

Study Design - RCTStudy Design - RCT

Baseline Assessment Eligibility

HIV Education (HE) (1 Session)

Safer Sex Skills Building (SSB) (5 Sessions)

Cohort Randomization (n=515)

3 Month FU

6 Month FU

Post Treatment

CTN-0019

Observed (Baseline) and Predicted Observed (Baseline) and Predicted Means (3- and 6-Months) for USOMeans (3- and 6-Months) for USO

CTN-0019

0

5

10

15

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30

Unp

rote

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sex

ual o

ccas

ions

HE SSB

HE 19.96 17.73 24.14

SSB 18.6 15.08 13.96

Baseline (obsrvd) 3 months (pred) 6 months (pred)

Analysis of USO: SummaryAnalysis of USO: Summary

• Significant effect of SSB, as compared to HE, over Significant effect of SSB, as compared to HE, over time (E.S. = 0.42; p<0.0001) SSB had 29% fewer time (E.S. = 0.42; p<0.0001) SSB had 29% fewer USOs than HE – at 6 monthsUSOs than HE – at 6 months

• While both interventions prompted initial decrease While both interventions prompted initial decrease in USOs, only SSB in USOs, only SSB sustainedsustained this decrease at 6 this decrease at 6 monthsmonths

• To maintain complex sexual risk behavior change To maintain complex sexual risk behavior change among women, among women, activeactive, , experientialexperiential and and empoweringempowering interventions are needed interventions are needed

CTN-0019

Real World ImplicationsReal World Implications(T3-Translation to Practice)(T3-Translation to Practice)

• A brief, effective, gender-specific, skills-A brief, effective, gender-specific, skills-oriented sexual risk reduction intervention oriented sexual risk reduction intervention can be delivered by trained counselors at can be delivered by trained counselors at community drug treatment programscommunity drug treatment programs

• The The train-the-trainertrain-the-trainer model has particular model has particular promise for promise for sustainabilitysustainability

• Web-based technology versions of SSB may Web-based technology versions of SSB may contribute in disseminating this effective contribute in disseminating this effective interventionintervention

CTN-0019

CTN’s Public Data Share www.ctndatashare.org

Fourteen studies currently posted for data share including studies on:

• Buprenorphine (3)

• Motivational Enhancement Therapy/Motivational Interviewing (4)

• Contingency Management (2)

• Community Treatment Program Surveys (2)

*****HIV trials (3) will be posted by the end of 2008

Published Secondary AnalysisUsing CTN’s Public Data Share

Secondary Analysis

Secondary Analyses in ProgressUsing CTN’s Public Data Share

• Gender differences in the prevalence and predictors of HIV risk behaviors, Audrey Brooks et al.

• Pattern of alcohol use and alcohol-related diagnoses among drug abusing/dependent participants, Dennis Donovan et al.

• The relationships between demographic characteristics of patients and therapists, measures of therapeutic process and therapeutic alliance, and outcomes, Alyssa Forcehimes et al.

• Stimulant dependence symptom profiles among treatment-seeking stimulant users: a latent class analysis, Li-Tzy Wu et al.

• An item response theory analysis of the DSM-IV checklist: a NIDA Clinical Trials Network study, Li-Tzy Wu et al.

• An item response theory analysis of alcohol and marijuana dependence: a NIDA Clinical Trials Network study, Li-Tzy Wu et al.

Secondary Analysis