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Abstract: Randomized clinical trials (RCTs) typically report patient-oriented outcomes. However, site engagement in RCTs requires substantial investment in personnel, training, and institutional resources, which may have lasting effects on personnel and institutional culture. Additionally, engagement in research has been associated with improved health care performance at the institutional level, including in prior studies at substance use treatment centers within the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN). Nonetheless, little has been reported about downstream effects of site participation for emergency department (ED)-based studies, including investigator professional advancements and institution-wide improvements in clinical practice. This commentary piece describes individual- and site-level benefits associated with participation in the Emergency Department-Initiated Buprenorphine and Validation Network Trial (ED-INNOVATION, CTN-0099). Related protocols: CTN-0099

Abstract:

Clinical research is increasingly being conducted in community-based addiction treatment settings. Although the primary focus of such research is on the development of effective clinical interventions, less attention has been paid to the potential impact of these projects on counseling staff who are involved in their implementation. Such involvement may be perceived as stressful or rewarding, and these perceptions may be associated with counselors’ intention to remain in their jobs (“turnover intention”). Using data from 207 counselors involved in research projects conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN), this study examines the associations between counselors’ reactions to research experiences and turnover intention. Counselors’ turnover intentions were found to be associated with their perceptions about the research activities their organizations were involved in. Turnover intention was significantly greater whenever counselors perceived that their job demands had increased due to the research. However, turnover intention was significantly lower if counselors perceived that the research was resulting in improvements for their clients and organization.

These findings suggest that the impact of clinical trials on treatment organizations and staff members warrants continued study.

Abstract:

American Indian and Alaska Native (AI/AN) populations are disproportionately affected by substance use disorders (SUDs) and related health disparities in contrast to other ethnoracial groups in the United States. Over the past 20 years, substantial resources have been allocated to NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) to disseminate and implement effective SUD treatments in communities. However, we know little about how these resources have benefitted AI/AN peoples with SUD who arguably experience the greatest burden of SUDs. This review aims to determine lessons learned about AI/AN substance use and treatment outcomes in the CTN and the role of racism and Tribal identity.

The authors conducted a scoping review informed by the Joanna Briggs framework and PRISMA Extension for Scoping Reviews checklist and explanation. The study team conducted the search strategy within the CTN Dissemination Library and nine additional databases for articles published between 2000 and 2021. The review included studies if they reported results for AI/AN participants. Two reviewers determined study eligibility.

A systematic search yielded 13 empirical articles and six conceptual articles. Themes from the 13 empirical articles included: (1) Tribal Identity: Race, Culture, and Discrimination; (2) Treatment Engagement: Access and Retention; (3) Comorbid Conditions; (4) HIV/Risky Sexual Behaviors; and (5) Dissemination. The most salient theme was Tribal Identity: Race, Culture, and Discrimination, which was present in all articles that included a primary AI/AN sample (k = 8). Themes assessed but not identified for AI/AN peoples were Harm Reduction, Measurement Equivalence, Pharmacotherapy, and Substance Use Outcomes. The conceptual contributions used AI/AN CTN studies as exemplars of community-based and Tribal participatory research (CBPR/TPR).

Conclusions: CTN studies conducted with AI/AN communities demonstrate culturally congruent methods, including CBPR/TPR strategies; consideration/assessment of cultural identity, racism, and discrimination; and CBPR/TPR informed dissemination plans. Although important efforts are underway to increase AI/AN participation in the CTN, future research would benefit from strategies to increase participation of this population. Such strategies include reporting AI/AN subgroup data; addressing issues of cultural identity and experiences of racism; and adopting an overall effort for research aimed at understanding barriers to treatment access, engagement, utilization, retention, and outcomes for both treatment and research disparities for AI/AN populations.

Abstract:

There is growing concern regarding the generalizability of findings from randomized controlled trials (RCTs) of interventions for substance use disorders (SUDs). This study used a selection model approach to assess and improve the generalizability of an evaluation for a web-based SUD intervention by making the trial sample resemble the target population.

The sample of the web-based SUD intervention (Therapeutic Education System vs. treatment-as-usual; n=507) was compared with the target population of SUD treatment-seeking individuals from the Treatment Episodes Data Set-Admissions (TEDS-A). Using weights based on the probabilities of RCT participation, weighted treatment effects on retention and abstinence were computed.

Substantial differences between the RCT sample and the target population were demonstrated in significant difference in the mean propensity scores (1.62 standard deviations at p<.001). The population effect on abstinence (12 weeks and 6 months) was statistically insignificant after weighting the data with the generalizability weight.

Conclusions: Findings from this study provide insights into the differences between RCT participants of a web-based SUD intervention and the target population from recent years. The results of this study also indicate how poor sample representativeness of the RCT compared with the target population impacted the observed findings of the web-based SUD intervention. Given the great potential for scalability of web-based SUD interventions, the representativeness of the sample with regard to the target population of potential users for the intervention should be carefully considered. Additionally, with a careful consideration of the treatment effect modifiers which are over- or under-representing in RCTs, application of generalizability weights could be a potentially useful tool for assessing and improving the generalizability of the findings from RCTs when the RCT sample does not well-represent the target population.

Related protocols: CTN-0044

Abstract:

There is growing concern that the results from randomized controlled trials (RCTs) might not generalize to real world settings, particularly in the context of RCTs of treatments for substance use disorders (SUDs). Limitations in generalizability of the findings from RCTs pose major clinical and policy concerns because RCTs are considered the most accepted study design for choosing evidence-based practices. The randomized study design does not necessarily ensure external validity, which means that the findings of an RCT may not be applicable to all individuals for whom treatment or intervention is intended. Individuals who volunteer to participate in RCTs are typically different from those who refuse to participate. Furthermore, strict eligibility criteria are likely to make the findings less applicable to subgroups who are excluded from trials.

This study had two main aims: 1) to estimate sample treatment effects and the population effects of RCTs of SUD treatment, and 2) to examine the treatment effect heterogeneity by subgroups that are under- or over-represented in a set of RCTs conducted by the NIDA Clinical Trials Network.

Statistical weighting was used to re-compute the effects from ten CTN RCTs such that the participants in the trials had characteristics that resembled those of patients in the target populations. Three outcomes of SUD treatment were examined: retention, urine toxicology, and abstinence. The RCT sample treatment effects were weighted using propensity scores representing the conditional probability of participating in RCTs.

Weighting the samples changed the significance of estimated sample treatment effects. Most commonly, positive effects of trials became statistically non-significant after weighting (three trials for retention and urine toxicology, and one trial for abstinence); but also, non-significant effects became significantly positive (one trial for abstinence), and significantly negative effects became non-significant (two trials for abstinence). There was suggestive evidence of treatment effect heterogeneity in subgroups that are under- or over-represented in the trials, some of which were consistent with the differences in average treatment effects between weighted and unweighted results.

Conclusions: The findings of randomized controlled trials (RCTs) for substance use disorder treatment do not appear to be directly generalizable to target populations when the RCT samples do not adequately reflect the target populations and there is treatment effect heterogeneity across patient subgroups. Results from this study provide a first insight into whether and how deviations in RCT sample representativeness from target populations influence the observed outcomes of SUD RCTs. It is critical for future CTN studies to place greater emphasis on external validity of RCTs, particularly because a primary goal of the NIDA CTN was to provide data on SUD treatment that can be disseminated in usual care settings.

Abstract:

Despite considerable empirical evidence that psycho-social interventions improve addiction treatment outcomes across populations, implementation remains problematic. A small body of research points to the importance of research network participation as a facilitator of implementation; however, studies examined limited numbers of evidence-based practices. To address this gap, the present study examined factors impacting implementation of motivational interviewing (MI). This study used data from a national sample of privately funded treatment programs (n=345) and programs participating in the NIDA Clinical Trials Network (CTN) (n=156). Data were collected via face-to-face interviews with program administrators and clinical directors (2007-2009). Analysis included bivariate t tests and chi-square tests to compare private and CTN programs, and multivariable logistic regression of MI implementation.

A majority (68%) of treatment programs reported use of MI. Treatment programs participating in the CTN (88.9%) were significantly more likely to report use of MI compared with non-CTN programs (58.5%; P<0.01). CTN programs (82.1%) also were more likely to use trainers from the Motivational Interviewing Network of Trainers as compared with private programs (56.1%; P<0.05). Multivariable logic regression models reveal that CTN-affiliated programs and programs with a psychiatrist on staff were more likely to use MI. Programs that used the Stages of Change Readiness and Treatment Eagerness Scale assessment tool were also more likely to use MI, whereas programs placing greater emphasis on confrontational group therapy were less likely to use MI.

Conclusions: These findings suggest the critical role of research network participation, access to psychiatrists, and organizational compatibility in the adoption and sustained use of MI for the treatment of substance use disorders. Results suggest that as treatment programs begin the implementation process, special attention should be paid to creating an organizational climate receptive to innovation, and also the critical infrastructure necessary to facilitate implementation of psychosocial EBPs such as MI.

Abstract:

Randomized controlled trials (RCTs) are generally considered the gold standard for establishing the effectiveness of new interventions. However, lack of external validity, which indicates how well findings from one particular setting can apply to the target population, can be an issue with many RCTs. This study aimed to compare characteristics of individuals participating in randomized controlled trials of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods.

Analyses using data from RCT samples from multiple sites in the NIDA Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A) were performed. Participants included a total of 3,592 individuals from 10 CTN samples and 1,602,226 individuals selected from TEDS-A between 2001 and 2009.

Propensity scores for enrolling in the RCTs ere computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use, and the number of prior treatments. The proportion of those with 12 or more years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at p<.001.

Conclusions: In the U.S., individuals recruited into randomized controlled trials (RCTs) of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. Representativeness of the trial samples in future CTN trials should be carefully considered, particularly because the primary mission of the CTN was to improve the quality of SUD treatment nationwide. Less stringent exclusion criteria may improve generalizability and result in more representative samples in SUD treatment RCTs.

Abstract:

Internal process improvements embedded within the Network for Improvement of Addiction Treatment (NIATx) program are promising innovations for improving substance use disorder (SUD) treatment performance, such as engagement and retention. To date, few studies have examined the variables that may increase diffusion and implementation of NIATx innovations. This study investigates organization characteristics associated with SUD treatment center utilization of NIATx process improvements in a sample of 458 treatment programs, including programs participating in NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN). Overall, 19% had utilized NIATx process improvements. After statistically controlling environmental factors, five organizational variables were associated with the likelihood that treatment centers used NIATx processes. Organization size, administrative intensity, membership in a provider association, and participation in the CTN were positively associated with the odds of utilizing NIATx processes, while the association for the level of slack resources was negative.

Conclusions: From a practical perspective, this study illustrates that the willingness of treatment centers to undertake process improvements through NIATx processes can be explained to a large extent by organizational factors. Policies and related supportive efforts may be required to facilitate diffusion and implementation of NIATx processes to affect SUD treatment center performance and capacity.

Abstract:

This one hour session, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public and presented by Julia Gorey, JD, of the Office for Human Research Protections (DHHS), will acquaint research staff with characteristics of a prisoner and requirements in research based on current regulations and protections as well as the application process.

Learning objectives include:

• – Explain the regulatory interpretation of “prisoner” under 45 CFR 46;
• – Explain permissible categories of research at 45 CFR 46.306, and the Epidemiological Waiver;
• – Describe requirements for a prisoner representative and IRB review;
• – Describe the requirements for certification, the process of certification, and the necessary contents of a certification package.

Additional Resources:

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Abstract:

This presentation provides an overview of the organization, mission, and history of NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) in New England, including clinical research trials completed by New England programs participating in the CTN. The CTN was developed partially in response to a 1998 Institute of Medicine Report that spoke of the “serious gaps of communication” between the research community and community-based drug treatment programs. There is also a gap between social work research and practice in the addictions, with one national study of MSW degree programs finding that only 14.3% of accredited schools offered specializations in addiction. The CTN is a partnership between academic research centers and community drug abuse treatment programs, with the aim of developing and implementing multi-site clinical research studies and supporting the dissemination and adoption of any evidence-based interventions that result.

The CTN in New England began with two nodes in 2002 — the Northern New England Node (with a Regional Research Training Center (RRTC) at McLean Hospital/Harvard) and the New England Node (RRTC at Yale). In 2010 (through the present), those two nodes were combined to form the New England Consortium Node (with McLean and Yale serving as co-RRTCs). The New England node(s) have participated in 9 protocols (as well as the 2 additional baseline studies all CTN organizations participated in), between 2002-2013. Aims and outcomes from those studies are presented, followed by a brief introduction to some of the new studies currently being launched in the network.

CTN studies can also be used as a model to test interventions relevant to social work, such as sexual risk reduction skills training. Social workers are involved in the CTN, serving as study principal investigators, executive directors in treatment programs, program managers, counselors, and research assistants. The CTN is a valuable mechanism for training social workers in the delivery of empirically-supported treatments and counseling styles, and can also serve as a training platform for future careers in the field. Social workers can — and do! — play a vital role in helping to bridge the gap between research and treatment in the substance abuse field.

Abstract:

Rates of adoption of evidenced-based practices to treat opioid dependence, including the use of medications, are low and severely limit secondary prevention efforts to curtail the prescription drug epidemic. The goal of this article was to describe how involvement in a research clinical trials network, the National Drug Abuse Treatment Clinical Trials Network (CTN), facilitated the adoption of medications to treat opioid dependence at two community-based treatment programs (CTPs) affiliated with the Ohio Valley Node (OVN) of the network. Both programs are large, not-for-profit facilities that treat patients with either public or private insurance. One program, Maryhaven, had limited experience using FDA-approved medications to treat opioid dependence before joining the CTN; the other, Midtown, had a methadone clinic but no experience with buprenorphine or naltrexone. This article discusses the adoption of medications to treat opioid dependence in these two programs by highlighting critical turning points, lessons learned, and challenges encountered.

Conclusions: The NIDA CTN is a research network that facilitates the adoption of innovative science-based treatments for SUDs. One of the intrinsic values of participating in a research network is that the infrastructure allows opportunities for collaborative relationships to develop, building trust over time, and ultimately providing a professional network that can provide technical assistance that may be the final barrier to adoption or serve as a tipping point for adoption. Participation in a clinical trials network may facilitate adoption by providing the infrastructure for trialability and observability, but the most critical function may be the knowledge translation that occurs through the individual-level professional relationships that develop.

Abstract:

The Affordable Care Act calls for integration of substance abuse treatment into medical care via medical homes and continuing specialty care. For this integration to occur in the substance abuse treatment field, substantial sharing and dissemination of information by treatment providers is required. This study explored the determinants of organizational activities directed at disseminating evidence-based practices (EBPs) undertaken by 193 community treatment programs who are members of the National Institute on Drug Abuse’s National Drug Abuse Treatment Clinical Trials Network (CTN). Using factor analysis, the research identified two generic categories reflecting different motivations for dissemination activities and explored both treatment center leadership and organizational characteristics as determinants of these different types of dissemination activities. Organizational characteristics predicting treatment center dissemination activities included size, previous involvement in research protocols, linkages with other providers, and having non-profit status. The treatment center leader’s membership in professional organizations was also a significant determinant. Organization variables account for a larger portion of the variance in treatment center dissemination activities.

Conclusions: The results suggest that the willingness of treatment providers to help disseminate EBPs within the industry may be heavily influenced through shared network connections with other treatment organizations. Policy leaders’ efforts to increase EBP implementation and care integration targeted by the ACA may want to pay particular attention to the effects of network involvement found in this study.

Abstract:

There is a growing body of research supporting the use of buprenorphine and other medication assisted treatments (MATs) for the rapidly accelerating opioid epidemic in the United States. Despite numerous advantages of buprenorphine (accessible in primary care, no daily dosing required, minimal stigma), implementation has been slow. As the field progresses, there is a need to understand the impact of participation in practitioner-scientist research networks on acceptance and uptake of buprenorphine. This paper examines the impact of research network participation on counselor attitudes toward buprenorphine addressing both counselor-level characteristics and program-level variables using hierarchical linear modeling (HLM) to account for nesting of counselors within treatment programs. Using data from the National Treatment Center Study, this project compares privately funded treatment programs (n=345) versus programs affiliated with the National Institute on Drug Abuse Clinical Trials Network (CTN) (n=198). Models included 922 counselors in 172 CTN programs and 1,203 counselors in 251 private programs. Results of two-level HLM logistic (Bernoulli) models revealed that counselors with higher levels of education, larger caseloads, more buprenorphine-specific training, and less preference for 12-step treatment models were more likely to perceive buprenorphine as acceptable and effective. Furthermore, buprenorphine was 50% more likely to be perceived as effective among counselors working in CTN-affiliated programs as compared to private programs.

Conclusions: This study suggests that research network affiliation positively impacts counselors’ acceptance and perceptions of buprenorphine. Thus, research network participation can be utilized as a means to promote positive attitudes toward the implementation of innovations including medication assisted treatment.

Abstract:

The National Drug Abuse Treatment Clinical Trials Network (CTN) is a practice-based research network that partners academic researchers with community based substance use disorder (SUD) treatment programs designed primarily to conduct effectiveness trials of promising interventions. A secondary goal of the CTN is to widely disseminate results of these trials and thus improve the quality of SUD treatment in the U.S. Drawing on data from 156 CTN programs, this study examined the associated between involvement in CTN protocols and overall treatment quality measured by a comprehensive index of 35 treatment services. Negative binomial regression models show that treatment programs participating in a greater number of CTN protocols had significantly higher levels of treatment quality, an association that held after controlling for key organizational characteristics. Given that protocol participation was positively associated with quality of treatment, the question remains about how to successfully translate this knowledge and skill base to community-based treatment programs that are not directly involved in clinical research. The CTN has undertaken a number of dissemination initiatives to do just that, including the NIDA/SAMHSA Blending Initiative and the CTN Dissemination Library, though there have been few studies examining the direct impact of these dissemination activities on the quality of treatment services within and outside the CTN.

Conclusions: At their core, practice-based research networks, such as the CTN, offer community based clinicians the opportunity to bring innovation to and to address problems encountered in everyday treatment practice. They also provide an opportunity to identify barriers to implementation and to tailor implementation strategies to meet the real world needs of community-based treatment programs. However there are significant strides to be made in disseminating knowledge, skills, and training to programs that do not actively participate in clinical research in the wider treatment community. These findings contribute to the growing body of research on the role of practice-based research networks in promoting health care quality.

Abstract:

Currently there are more and more clinical trials conducted where clinical practice takes place — a community-based medical clinic. However, most of the “real life” clinics are not usually involved in research activities and for them, most of the research-oriented procedures (especially the regulatory procedures and paperwork) could be burdensome. Health care providers are very busy in their day to day work and have little time to become familiar with all the research procedures before starting recruitment in a multi-site clinical trial. Based on their experience in conducting multi-site clinical trials involving community treatment programs, the speakers in this session addressed critical regulatory issues and provided some examples on how to manage and reduce the burden from several perspectives: sponsor, investigator, IRB reviewer and provider. The presentation ended with a look from the provider perspective, summarizing the issues and recommendations discussed and answering the question, “Why become a community treatment program research site?”