Recent Scientific Findings from The Clinical Trials Network

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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)

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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) 6877
CTN-0009
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Study Flow
225 participants expressing desire to quit
smoking randomized at 5 methadone and 2 drug and
alcohol abuse clinics
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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
CTN-0009
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Smoking Cessation in Outpatient Treatment

• SC treatment reduced
• number of cigarettes smoked
• breath CO levels
• craving

CTN-0009
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Smoking Cessation in Outpatient Treatment

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

CTN-0009
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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
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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
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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, plt.05)

CTN-0013
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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
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Study Design - RCT
Baseline Assessment Eligibility
Cohort Randomization (n515)
HIV Education (HE) (1 Session)
Safer Sex Skills Building (SSB) (5 Sessions)
Post Treatment
3 Month FU
6 Month FU
CTN-0019
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Observed (Baseline) and Predicted Means (3- and
6-Months) for USO
CTN-0019
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Analysis of USO Summary

• Significant effect of SSB, as compared to HE,
  over time (E.S. 0.42 plt0.0001) 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
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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-trainer model has particular
  promise for sustainability
• Web-based technology versions of SSB may
  contribute in disseminating this effective
  intervention

CTN-0019
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CTNs 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

Secondary Analysis
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Published Secondary Analysis Using CTNs Public
Data Share
Secondary Analysis
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Secondary Analyses in Progress Using CTNs 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
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