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Integrating Services Research into CTN Clinical Trials: The Synergy is in the Details.

Presented at the Addiction Health Services Research Conference, October 15-17, 2007, Athens, GA.

Harold I. Perl, PhD (Center for the Clinical Trials Network (CCTN), National Institute on Drug Abuse (NIDA)).

The NIDA Clinical Trials Network (CTN) blends the skill and experience of two key groups of experts in drug abuse treatment: community-based treatment providers and academic researchers. More than 240 community treatment programs (CTPs) are spread across the 17 CTN Nodes and comprise a diverse and extensive network of sites interested in developing and participating in a variety of research endeavors, including health services research projects. However, incorporating services research into a multi-site clinical trial is a complex process, regardless of whether the trial is in its earliest stages of development or has been in the field for some time.

This presentation describes the interdigitation of three different services research projects into CTN-supported clinical trials and highlights the specific demands inherent when this occurs at each of three stages in the host study’s progress: deployed in the field; in a late stage of development; or in an early, formative state. The first example describes protocol CTN-0030 (Prescription Opiate Abuse Treatment Study), which is examining the impact of two medication management models of varying expense and complexity for patients with opioid analgesic dependence. It had been in the field for over a year when the additional HSR project was proposed to conduct cost-effectiveness analyses, including the cost of incremental benefits if one model proves superior. The second example presents a trial to study the impact of rapid testing for HIV infection combined with a brief counseling intervention (CTN-0032, HIV Rapid Testing and Counseling). It was in its first stage of operational development when the additional HSR project was proposed to examine its cost-effectiveness. The third example describes a trial that examines a combined group/individual intervention to facilitate engagement of stimulant abusers into community-based 12-step groups (CTN-0031, Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)) . It had been in its final stages of operational planning when the HSR project was proposed to examine the impact of organizational characteristics at the CTP-level on the eventual implementation and adoption of the intervention after trial completion. This third scenario provides a close look at the intricate negotiations between the “external” HSR researchers and the scientists, research operation managers, statisticians, and database managers at the CTN study required to integrate the proposed HSR project smoothly and productively. The presentation concludes with descriptions of specific opportunities for other interested health services researchers to develop collaborative relationships with the CTN sites. (Presentation, PPT, English, 2007)

Keywords: Buprenorphine | Buprenorphine/Naloxone | Community health services | Health services research | HIV/AIDS | HIV rapid testing | Methamphetamine | Opioid dependence | Opioid detoxification | Pharmacological therapy | Sexual risk behavior |Sexually transmitted diseases | Suboxone | Subutex | Stimulant abuse | Twelve-Step Programs | Addiction Health Services Research conference, 2007

Document No: 248

Submitted by Jeffrey A. Selzer, MD, 10/19/2007.

Perl, Harold I. search mail
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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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