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Abstract: The National Institute on Drug Abuse created the Clinical Trials Network (CTN) to bridge the gap between research and clinical practice relative to the treatment of substance use disorders in 1999. Since that date, 27 research protocols have been completed, some involving counseling approaches, some involving medication assisted treatment, and some involving both. Currently, the CTN is composed of approximately 167 treatment programs in 34 States, with multiple treatment programs across the country involved in each research protocol. It became apparent that there was no consensus about the most appropriate outcome measures to use relative to treatment efficacy or the methods to assess those outcomes, both within the CTN and across the literature in general. A task force was approved by the Executive Committee of the CTN in November 2008 with the following goals: (1) to recommend a definition for a clinically meaningful outcome measure on drug use to be used in CTN clinical trials, and (2) to recommend a set of key questions/instruments that would be used across CTN clinical trials. This presentation will examine the conclusions of the task force and the relevance of those conclusions to substance abuse research and clinical practice.

Abstract:

Based on recommendations from a U.S. Institute of Medicine report, the National Institute on Drug Abuse established the National Drug Abuse Treatment Clinical Trials Network (CTN) in 1999 with the goal of accelerating the translation of science-based addiction treatment research into community-based practice, and improving the quality of addition treatment using science as the vehicle. One of the CTN’s primary tasks is to serve as a platform to forge bidirectional communications and collaborations between providers and scientists to enhance the relevance of research generating empirical results that impact practice. Among the many obstacles in moving research into real-world settings, this commentary mainly describes challenges and iterative experiences in regard to how the CTN develops its research protocols, with a focus on how the CTN study teams select and utilize assessment instruments that can reasonably balance the interests of both research scientists and practice providers when applied in CTN settings. This commentary also discusses the process by which the CTN has worked to identify a core set of common assessment instruments (the Common Assessment Battery (CAB)) that may be applied across all trials. Collecting clinically-relevant data in a uniform manner over time using the CAB will greatly facilitate future cross-study analyses, which could yield rich and important information to improve treatment of individuals with substance use disorders and to enhance the advancement of substance use disorder-related clinical research.

Abstract:

There is need to improve treatment effectiveness for stimulant misusers, and one means of doing so is by tailoring services to account for the common diagnostic comorbidities and psychosocial challenges this population can face. Using its publicly available datasets, this CTN-approved secondary analysis project examined prevalence of alcohol use disorders (AUDs) among primary stimulant misusing treatment-seekers as well as impact of AUD comorbidity on their pre-treatment psychosocial functioning. Upon identifying a primary stimulant misuser subsample (N = 1133) from among aggregated treatment-seekers across eight CTN trials, diagnostic data were used to document lifetime AUD rates. Paired comparisons, stratified by stimulant drug type (e.g., amphetamine, cocaine) then tested the influence of AUD comorbidity on psychosocial indices from the Addiction Severity Index–Lite. A high AUD rate (45%) was found in this client population. Among primary cocaine misusers, those with AUD were more likely to: (1) show elevated Addiction Severity Index composite scores, (2) perceive greater importance of drug treatment, and (3) endorse psychiatric symptoms and perceived need for their treatment. Among primary amphetamine misusers, those with AUD were more likely to endorse specific psychiatric symptoms.

Conclusions: Study findings document AUD comorbidity as a fairly common diagnostic feature of primary stimulant misusers, and suggest it is a pervasive influence on the pre-treatment psychosocial functioning of cocaine misusers. This study demonstrates the utility of CTN common assessment battery for secondary analysis projects, though challenges noted during its conduct highlight the value of consistent data collection and documentation within and across CTN trials.

Related protocols: CTN-0004, CTN-0006, CTN-0007, CTN-0009, CTN-0013, CTN-0017, CTN-0018, CTN-0019

Abstract:

In November 2008, the CTN Executive Committee approved the formation of an ad hoc task force to address two goals and make a recommendation to the CTN Steering Committee. The first of these goals was to develop a clinically meaningful outcome standard for drug use to be used in CTN clinical trials, as well as a method to capture that outcome. The second goal was to recommend a set of key screening and assessment questionnaires and instruments to be used CTN-wide. This document represents the task force’s recommendations, including discussion of the importance of capturing drug use consequence information as well as information about successful or failed abstinence, examination of the strengths and weaknesses of various screening instruments, and a comparison of the task force’s recommendations with the CTN Common Assessment Battery (CAB).

Abstract:

This article describes the process undertaken within the CTN to select the most suitable substance abuse disorders diagnostic instrument for use in community-based clinical trials.

Five widely-recognized instruments were evaluated by a panel of university researchers and community-based treatment providers. After considering the pragmatic and scientific pros and cons of each instrument, the CTN Steering Committee selected the CIDI-2 as the common diagnosistic tool for practitioners and clinical researchers in the CTN.