Recent Scientific Findings from The Clinical Trials Network

1. Recent Scientific Findings from The Clinical Trials Network Betty Tai, Ph.D. Steven Sparenborg, Ph.D. (CTN-0009) Petra Jacobs, M.D. (CTN-0013) Raúl Mandler, M.D. (CTN-0019) Paul Wakim, Ph.D. (Secondary Analysis)

2. Smoking Cessation Treatment in Community-based 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 CTN-0009

3. Study Flow 225 participants expressing desire to quit smoking randomized at 5 methadone and 2 drug and alcohol abuse clinics 2:1 Smoking Cessation (9 group sessions & patch) + Substance Abuse TAU N = 153 Substance Abuse TAU + Post FU SC (offered) N = 72 Completers N = 142 Completers N = 68 CTN-0009

4. Smoking Cessation in Outpatient Treatment • SC treatment reduced: • number of cigarettes smoked • breath CO levels • craving CTN-0009

5. Smoking Cessation in Outpatient Treatment • Concurrent SC and AoD dependence treatment does not worsen AoD treatment outcomes CTN-0009

6. 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 CTN-0013

7. 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

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

9. HIV/STD Safer Skills Groups for Women in Methadone Maintenance or Psychosocial Outpatient Treatment Effectiveness of HIV/STD Sexual Risk Reduction Groups For Women In Substance Abuse Treatment Programs: Results 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 2008 48(5): 581-589 CTN-0019

10. Study Design - RCT Baseline Assessment Eligibility Cohort Randomization (n=515) HIV Education (HE) (1 Session) Safer Sex Skills Building (SSB) (5 Sessions) Post Treatment 3 Month FU 6 Month FU CTN-0019

11. Observed (Baseline) and Predicted Means (3- and 6-Months) for USO CTN-0019

12. Analysis of USO: Summary Significant effect of SSB, as compared to HE, over time (E.S. = 0.42; p<0.0001) SSB had 29% fewer USOs than HE – at 6 months While both interventions prompted initial decrease in USOs, only SSB sustained this decrease at 6 months To maintain complex sexual risk behavior change among women, active, experiential and empowering interventions are needed CTN-0019

13. Real World Implications(T3-Translation to Practice) A brief, effective, gender-specific, skills-oriented sexual risk reduction intervention can be delivered by trained counselors at community drug treatment programs The train-the-trainermodel has particular promise for sustainability Web-based technology versions of SSB may contribute in disseminating this effective intervention CTN-0019

14. CTN’s Public Data Sharewww.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 Secondary Analysis

15. Published Secondary Analysis Using CTN’s Public Data Share Secondary Analysis

16. Secondary Analyses in Progress Using 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