Harold I. Perl

Partnerships and pathways of dissemination: The National Institute on Drug Abuse—Substance Abuse and Mental Health Services Administration Blending Initiative in the Clinical Trials Network

Since 2001, the National Drug Abuse Treatment Clinical Trials Network (CTN) has worked to put the results of its trials into the hands of community treatment programs, in large part through its participation in the National Institute on Drug Abuse-Substance Abuse and Mental Health Services Administration Blending Initiative and its close involvement with the Center for Substance Abuse Treatments Addiction Technology Transfer Centers. This article describes (a) the CTNs integral role in the Blending Initiative, (b) key partnerships and dissemination pathways through which the results of CTN trials are developed into blending products and then transferred to community treatment programs, and (c) three blending initiatives involving buprenorphine, motivational incentives, and motivational interviewing. The Blending Initiative has resulted in high utilization of its products, preparation of more than 200 regional trainers, widespread training of service providers in most U.S. States, Puerto Rico, and the U.S. Virgin Islands and movement toward the development of Web-based implementation supports and technical assistance. Implications for future directions of the Blending Initiative and opportunities for research are discussed.

Stimulant abuser groups to engage in 12-Step: A multisite trial in the National Institute on Drug Abuse Clinical Trials Network

AIMS The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. DESIGN Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs). SETTING Intensive outpatient substance treatment programs. PARTICIPANTS Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. MEASUREMENTS Urinalysis and self-reports of substance use and 12-step attendance and activities. INTERVENTION Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers. FINDINGS Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. CONCLUSIONS The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU.

Study design to examine the potential role of assessment reactivity in the Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED) protocol

BackgroundScreening, brief intervention, and referral to treatment (SBIRT) approaches to reducing hazardous alcohol and illicit drug use have been assessed in a variety of health care settings, including primary care, trauma centers, and emergency departments. A major methodological concern in these trials, however, is “assessment reactivity,” the hypothesized impact of intensive research assessments to reduce alcohol and drug use and thus mask the purported efficacy of the interventions under scrutiny. Thus, it has been recommended that prospective research designs take assessment reactivity into account. The present article describes the design of the National Institute on Drug Abuse Clinical Trials Network protocol, Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED), which addresses the potential bias of assessment reactivity.Methods/designThe protocol employs a 3-arm design. Following an initial brief screening, individuals identified as positive cases are consented, asked to provide demographic and locator information, and randomly assigned to one of the three conditions: minimal screening only, screening + assessment, or screening + assessment + brief intervention. In a two-stage process, the randomization procedure first reveals whether or not the participant will be in the minimal-screening-only condition. Participants in the other two groups receive a more extensive baseline assessment before it is revealed whether they have been randomized to also receive a brief intervention. Comparing the screening only and screening + assessment conditions will allow determination of the incremental effect of assessment reactivity.DiscussionAssessment reactivity is a potential source of bias that may reduce and/or lead to an underestimation of the purported effectiveness of brief interventions. From a methodological perspective, it needs to be accounted for in research designs. The SMART-ED design offers an approach to minimize assessment reactivity as a potential source of bias. Elucidating the role of assessment reactivity may offer insights into the mechanisms underlying SBIRT as well as suggest clinical options incorporating assessment reactivity as a treatment adjunct.ClinicalTrials.gov IdentifierNCT01207791.

Design of NIDA CTN Protocol 0047: Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)

Background: Medical settings such as emergency departments (EDs) present an opportunity to identify and provide services for individuals with substance use problems who might otherwise never receive any form of assessment, referral, or intervention. Although screening, brief intervention, and referral to treatment models have been extensively studied and are considered effective for individuals with alcohol problems presenting in EDs and other medical settings, the efficacy of such interventions has not been established for drug users presenting in EDs. Objectives: This article describes the design of a NIDA Clinical Trials Network protocol testing the efficacy of an screening, brief intervention, and referral to treatment model in medical EDs, highlighting considerations that are pertinent to the design of other studies targeting substance use behaviors in medical treatment settings. Methods: The protocol is described, and critical design decisions are discussed. Results: Design challenges included defining treatment conditions, study population, and site characteristics; developing the screening process; choosing the primary outcome; balancing brevity and comprehensiveness of assessment; and selecting the strategy for statistical analysis. Conclusion: Many of the issues arising in the design of this study will be relevant to future studies of interventions for addictions in medical settings. Scientific Significance: Optimal trial design is critical to determining how best to integrate substance abuse interventions into medical care.

A Combined Group and Individual 12-Step Facilitative Intervention Targeting Stimulant Abuse in the NIDA Clinical Trials Network: STAGE-12.

This paper discusses a unique collaboration between researchers, addiction community treatment providers (CTPs) and the National Institute on Drug Abuse (NIDA) in developing and implementing a multi-site clinical trial of a behavioral intervention for outpatients with stimulant use disorders. We describe the mission of the Clinical Trial Network (CTN) of NIDA which provided the infrastructure for this study, the process of adapting an intervention that combines individual and group sessions aim at facilitating addicted patients active involvement in 12-step mutual support programs, study questions addressed, outcomes of the intervention and why 12-step counseling approaches should be considered for a multi-site trial. We also discuss the structure and format of individual and group sessions, training and supervision of counselors through review of tapes of treatment sessions. This process emphasizes the importance of bidirectional collaboration between researchers and treatment providers and shows evidence of how CTPs participate in all phases of a trial from identifying an important clinical area to consider for research through protocol development and implementation. Results of data analysis will be presented in a future paper.

Constructing Quantitative Implementation Scales From Categorical Services Data Examples From a Multisite Evaluation

Like measures of outcome, measures of implementation are most useful and analytically powerful when measured at client-level and are quantitative. However, high-quality, individual-level, quantitative service utilization data can be expensive, intrusive, or otherwise impractical to obtain. Cruder data—for example, presence versus absence of a given service—are often more feasible to collect, as well as more likely to be available. Consequently, evaluators can benefit by finding ways to better exploit such data at the analysis phase to compensate for shortcomings at the collection phase. This article documents one such instance in which this was done. Specifically, it describes how quantitative, client-level implementation scales were derived from qualitative (categorical) data and used to support a cross-site synthesis of implementation and outcome analyses in a multisite evaluation. It also suggests additional scenarios in which quantitative implementation scales might be derived form qualitative services data.

How Practice and Science Are Balanced and Blended in the NIDA Clinical Trials Network: The Bidirectional Process in the Development of the STAGE-12 Protocol as an Example

Background: Bidirectional, collaborative partnerships between academic researchers and practitioners have been a fundamental vehicle to achieve the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) goal of improving outcomes of community-based drug treatment. These partnerships blend clinical perspectives of practitioners and methodological expertise of researchers working together to address clinically meaningful issues through randomized clinical trials conducted in community treatment settings. Objectives: Bidirectionality is a guiding principle of the CTN, but its operationlization at the practical level in protocol development and implementation has not been articulated. This descriptive article presents the development of one protocol as an example and model of this bidirectional, collaborative, iterative partnership between researchers and practitioners. Methods: This article illuminates several specific issues encountered while developing STAGE-12, a behavioral intervention to facilitate 12-step mutual support group involvement, as well as the rationale for decisions taken to resolve each. Results: The STAGE-12 protocol was successfully developed through a series of decisions taking into account both design factors and clinical practice needs and realities, thus maintaining a balance between methodological rigor and generalizability. Conclusion: The review demonstrates the process by which research and practice have been blended in protocol development, exemplifying the underlying principle of bidirectionality, a key element in the success of the NIDA CTN. Scientific Significance: Bidirectional partnerships as derived in the CTN, employing a hybrid model of efficacy-effectiveness research, are capable of designing and implementing protocols that are both methodologically rigorous and clinically meaningful, thus increasing likelihood of adoption and eventual improvement in public health.

The NIAAA Cooperative Agreement Program for Homeless Persons with Alcohol and Other Drug Problems: An Overview

Alcohol and other drug abuse represent the most predominant public health problem facing the nations growing homeless population. Few treatment services are available for homeless persons with alcohol or other drug abuse problems, and little is known about the effectiveness of these services. In 1990, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) launched a three-year, four-teen-project research demonstration program to develop, implement, and evaluate the effectiveness of treatment interventions for this target population. This article describes the background goals, and structure of the NIAAA Cooperative Agreement Program.

Enhancing Coordination Among the U.S. Preventive Services Task Force, Agency for Healthcare Research and Quality, and National Institutes of Health

This paper focuses on the relationships among the U.S. Preventive Services Task Force (USPSTF); Agency for Healthcare Research and Quality (AHRQ); and NIH. After a brief description of the Task Force, AHRQ, NIH, and an example of how they interact, we describe the steps that have been taken recently by NIH to enhance their coordination. We also discuss several challenges that remain and consider potential remedies that NIH, AHRQ, and investigators can take to provide the USPSTF with the data it needs to make recommendations, particularly those pertaining to behavioral interventions.

Transdisciplinary translational behavioral (TDTB) research: opportunities, barriers, and innovations.

The translation of basic behavioral science discoveries into practical strategies represents a promising approach to developing more effective preventive interventions to improve health. Since translational research inevitably involves making use of diverse perspectives from multiple disciplines, it is best conducted as a transdisciplinary enterprise. In this paper, we discuss current strategies used by NIH to support transdisciplinary translational behavioral (TDTB) research, summarize successful efforts, and highlight challenges encountered in conducting such work (ranging from conceptual to organizational to methodological). Using examples from NIH-funded projects we illustrate the potential benefits of, and barriers to, pursuing this type of research and discuss next steps and potential future directions for NIH-supported TDTB research.