Search the Library
NOTE: This is a new search platform (as of May 2026). If you do a search and don’t get the results you were expecting, please email us at ctnlib@uw.edu to let us know? (If possible, please share your exact search strategy. Thank you!)
Enter keywords and hit Enter (or click the magnifying glass) to search. You can then also select document type or subject/topic to narrow results further (or just use those for searching without a keyword). Results display below this search form.
Document types
Subjects
- CTN-#### format for protocols (CTN-0001, e.g.)
- “exact phrase” (if phrase is not found, it will return results that contain all terms
- word1 NOT word2
- word1 word2 (finds both words)
- Click title to access full-text
- “Show details” reveals abstract & other info
- Checkboxes select items for copy/pasting or printing
- Need help getting a copy of a journal article?
Email ctnlib@uw.edu
Search results
The National Drug Abuse Treatment Clinical Trials Network (CTN) was initiated by the National Institute on Drug Abuse (NIDA) in 2000 with the aim of improving substance use treatment and reducing the time between the discovery of effective treatments and their implementation into clinical practice. While initial trials were conducted almost exclusively in specialty addiction treatment settings, the CTN began evolving strategically in 2010 to conduct research in general medical settings, including healthcare systems, primary care settings, emergency departments, and pharmacies, to broaden impact. The advantages of a research network like the CTN is not only the collective content expertise that investigators contribute to the network, but the collective experience gained by conducting studies in the network and then applying those lessons to future studies.
This study aimed to summarize trial implementation challenges encountered, and the process by which solutions were identified and implemented, within one of the last early-phase CTN Stage II behavioral intervention studies conducted in a specialty addiction treatment setting, CTN-0037, the Stimulant Reduction Intervention Using Dosed Exercise (STRIDE) trial.
Issues encountered during study implementation are categorized into four major areas, described in terms useful to future study teams: 1) study team infrastructure challenges, 2) participant- and site- level challenges, 3) intervention-related challenges, and 4) longitudinal study design challenges. Potential consequences of identified problems and the solutions developed to manage these problems are discussed within the context of these four areas. The authors propose how to extend these implementation lessons and apply them in other healthcare settings to expand the CTN.
Conclusions: Effective study management allows for flexible, collaborative solutions to expected and unexpected obstacles to study success. Implementation strategies derived from the first 15 to 20 years of CTN studies are a result of working with providers and participants, and the ongoing collaboration among CTN investigators and network staff. Timely identification and response to problems during study implementation are critical to the success of a trial, regardless of its design. We believe a collaborative approach to identifying and responding to study implementation challenges will increase the likelihood of successful adoption of relevant, efficacious interventions. As the CTN continues to expand, the wealth of successful trial implementation strategies developed during the first 20 years of the CTN need to be applied and adapted to studies in broader network settings, and considered in conjunction with more formalized implementation science processes that are currently available.
Related protocols: CTN-0037
Missing data in substance use disorder (SUD) research pose a significant threat to internal validity. Participants terminate involvement or become less likely to attend intervention and research visits for many reasons, which should be addressed prior to becoming problematic. During a 9-month study targeting stimulant abuse, early dropouts and participant reported attendance barriers led to implementing a structured, pre-randomization protocol with participants about retention and solution-focused strategies (the “Fireside Chat”).
NIDA Clinical Trials Network protocol CTN-0037, Stimulant Reduction Using Dosed Exercise (STRIDE), was a two-arm, multisite randomized clinical trial testing treatment-as-usual for stimulant abuse/dependence augmented by Exercise or Health Education. For both groups, study intervention visits at the site were schedule 3/week for 12 weeks followed by 1/week for 24 weeks. During The Chat, research staff thoroughly reviewed participants’ expectations, and barriers and solutions to retention. Fifteen participants were randomized (to Exercise or Health Education) prior to and fourteen were randomized after Chat implementation. Intervention and monthly follow-up attendance (before and after implementation) were compared at the site (N=29) that developed and rigorously implemented The Chat.
Results found that individuals who participated in The Chat (n=14) attended significantly more intervention visits during weeks 1-12 (p<0.001) and weeks 13-36 (p<0.05) and attended more research visits (p<0.001).
Conclusions: The myriad barriers to research engagement that participants face require careful consideration by all stakeholders involved in research. The time investment for The Chat by potential participants and research staff is not trivial but it could produce important benefits for the study. Indeed, the increased validity of study results when less data are missing and staff time savings as the study progresses (e.g., less need for efforts to contact participants who have missed visits) are both quite important. Cooperative dialogue, beginning early in the recruitment phase and prior to randomization, is critical to engaging and retaining participants in SUD research as the collaborative partners they should be considered to be.
Related protocols: CTN-0037
While several pharmacotherapies have been developed for substance use disorders (SUD) in adults, relatively few have been studied in adolescents, and complex design and execution issues must be addressed to optimize the potential impact of current and future research in this important area. This one-hour presentation discussed method, design, and key strategies for the optimization of conduct/execution, overall treatment adherence, participant enrollment and retention, documentation, and management of adverse events for adolescent SUD pharmacotherapy trials. With adequate understanding of challenges and opportunities in the design and conduct of these trials, attendees were equipped to incorporate this information into their research practices.
Additional Resources:
- Download slides (pdf)
- Download handout (pdf)
The growing use of newer communication and internet technologies, even among low income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the internet to track participants in a multi-site randomized trial of substance use disorder treatment. Pre-interview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 sites participating in the National Drug Abuse Treatment Clinical Trials Network study CTN-0044, about an online intervention for substance use disorders (Therapeutic Education System). Data were then used to construct a semi-structured interview guide which, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant tracking purposes.
Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants’ cell phones also proved problematic at times. Even homeless participants were found to have access to the internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the Institutional Review Board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary websites were also helpful tool.
Conclusions: Research staff perceive that cell phones, internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research and should be used in addition to established study procedures. Studies should incorporate cell phone, texting, and social network website information on locator forms; obtain IRB approval for contacting participants using social networking websites; and include web searches, texting, and the use of social media in staff training as standard operating procedures.
Related protocols: CTN-0044
This workshop, led by Carmen Rosa of NIDA’s Center for the Clinical Trials Network, featured three presentations focused on the use of various types of new media in the design and conduct of clinical trials. Over 82% of adults now use internet or email, including 53% of those age 65 and older. Additionally, 67% of online adults use social networking sites. Mobile devices such as smartphones, tablets, netbooks, and laptops are now a primary source of Internet connectivity, and 79% of cell phone owners say they use text messaging. As use of these tools continues to grow, exploring ways to put them to use in clinical trials seems increasingly relevant.
The first presentation, by Erin Winstanley, “Using New Media Tools in the Design and Conduct of Clinical Trials,” provided an overview of the concept of “new media” and ways it can be applied to research, including advertising of studies, recruiting/tracking participants, communicating with participants, and disseminating research findings. An introduction to Facebook and Twitter is provided, as well as a look at the use of blogs, Pinterest, and LinkedIn.
Gloria Miele presented on “Social Media Communication Strategy,” giving participants a look at ways to think about and draft policies regarding the use of social media in your study or workplace. A variety of legal considerations, as well as examples of using social media to recruit study participants is also provided. Sample IRB guidance is included, along with IRB Best Practices for using new media. The presentation ends with a case study based on CTN-0044 (“Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders”), which used social media platforms like Facebook, as well as email and texting, to contact and follow-up with participants.
The third presentation, by Lynn Simpson, was a demonstration of the variety of uses for “REDCap, Research Electronic Data Capture, A Data Management and Survey Tool.” REDCap is a web-based application designed to give researchers and clinicians the capacity to create and manage databases and surveys in order to support data capture for research.
Related protocols: CTN-0044
High retention rates are critical for successful clinical trials, but participants in clinical research on stimulant abuse have demonstrated variable attendance at intervention and research visits. This poster reports on an innovative recruitment technique used by study staff in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0037 (Stimulant Reduction Intervention Using Dose Exercise (STRIDE)) to address some of the reasons for decreased attendance and barriers to retention before they become an issue for study participants. Nicknamed the “Fireside Chat,” the STRIDE approach used a series of “warm, supportive” questions to open a conversation with potential study participants, with the aim of helping them make an informed decision in a relatively short amount of time whether or not to join the study. Questions in the “chat” focused on willingness to commit, importance of the research question to the participant, understanding the requirements of participation, specific barriers to attendance, clarification of the study interventions/condition preference, and relapse potential.
Anecdotally, one site noted retention improvements after the Fireside Chat was implemented, and participants often expressed appreciation for taking part in the Chat. Though improvements cannot be solely attributed to the technique, research team members reported that being able to refer back to the Fireside Chat with participants helped them more openly discuss barriers to continued study participation. Clinical research with ongoing participant contact should consider tailoring this approach to increase retention. Future investigation with this approach is advised.
Related protocols: CTN-0037
I
n September 2011, the CTN Executive Committee (EC) discussed the need to attain high follow-up rates in CTN studies. For some studies such activity may involve engaging study participants in locations other than the research site. The EC recommended formation of a Taskforce to examine suggested best practices for follow-up and off-site procedures, with the goal of compiling a toolkit that includes principles to follow, guidelines, and supporting materials.
The Taskforce prepared this following Toolkit, organized as follows:
- The Conduct of Follow-up Assessments in the NIDA CTN: Principles to Follow.
- Follow-up in the Community- A Guide for CTN Investigators and Research Teams, a guide for CTN investigators, includes items to consider during protocol development when planning for off-site follow-up activities, and a tool for research teams during study implementation.
- Safety Precautions for CTN Field Staff – Guide and checklist for staff working in the field.
- Examples of Strategies Implemented to Facilitate Follow-up- provides key ingredients/strategies used in two CTN trials
- CTN 0032 HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.
- CTN 0044 Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders.
The Taskforce recognized that all studies are different and may require different strategies; however, this Toolkit may be used by investigators and research staff as a guide for general best practices, as well as preparation for CTN studies that include off-site or community follow-up. Above all, this Toolkit emphasizes the importance of proper preparation and planning in achieving meaningful follow-up rates.
Related protocols: CTN-0032, CTN-0044
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 (SBIRT) models have been extensively studied and are considered effective for individuals with alcohol problems presenting in emergency departments and other medical settings, there is much less evidence concerning the efficacy of such interventions for drug users presenting in EDs. This presentation describes the design of the National Drug Abuse Treatment Clinical Trials Network protocol “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)” (CTN-0047), with a focus on the screening, assessment, treatment conditions, and follow-up procedures. 1285 patients who screened positive for current problematic substance use were randomly assigned to: (1) Minimal screen only (MSO), (2) Screening, assessment, and referral to treatment (if indicated) (SAR); or (3) Screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster calls (BI-B). BI-B therapists received considerable training, ongoing supervision and formal fidelity monitoring. The three-arm design was implemented to control for assessment reactivity. Sites recruited an average of approximately 21 participants per site per month. Treatment exposure was nearly universal for the initial BI, but a significant number of participants could not be reached for one or both of the booster sessions. Although follow-up is ongoing, current rates of follow-up exceed those specified in the analysis plan.
Conclusions: The study was completed on time, with good treatment exposure, strong attention to treatment fidelity, and excellent follow-up rates. Study outcomes should provide strong evidence regarding the efficacy of this brief intervention strategy for drug users presenting in medical EDs.
Related protocols: CTN-0047
This 90-minute webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, begins with a “nuts and bolts” demonstration of how to set up a Facebook page and Twitter account for your organization. From there, it moves into discussions of best practices for use of these tools in research and clinical practice, as well as some of the regulatory and privacy issues involved.
The target audience is CTN members and other researchers and clinicians who are interested in learning how to use social media platforms as a research tool, best practices for recruitment and retention in research and clinical practice, and some of the regulatory and privacy issues involved.
Additional Resources:
- Social Media Resource Guide, 2012 (CTN RUC) (pdf)
- Download slides (pdf)
Recruitment and retention are a challenging task in the most ideal of environments and difficulties in recruitment and retention can lead to a drain on resources and threaten study success. Recruiting substance users from a medical Emergency Department (ED) setting poses many unique challenges as does tracking these participants for follow-up assessment. The recruitment and retention procedures from a NIDA Clinical Trials Network protocol designed to test the impact of a brief intervention on individuals presenting in medical EDs who screen positive for problematic drug use are described (CTN-0047: “Screening Motivational Assessment and Referral to Treatment in Emergency Departments (SMART-ED)”). Recruitment and the initial baseline assessment for this study take place at six different EDs in the United States. The population recruited in this study are high risk drug users with problems in many life domains including acute medical concerns, homelessness, legal troubles, and other problems that make tracking and retention difficult. We present recruitment and retention strategies that are helping us achieve our recruitment goals and maintain impressive follow-up rates for a difficult population from the protocol that is currently underway. Two factors were found to be key to successful recruitment in this study: 1) Appropriate selection of ED sites that promote successful recruitment by having available adequate patient volume of drug users, past research experience, and available space and staff to conduct research. 2) Thorough staff training occurring pre and post-recruitment commencement to ensure that staff are prepared and continually educated in proper recruitment techniques. We have found that numerous strategies and ongoing development of techniques are integral to retention success, which can be grouped under the following headings:1) Ongoing training and collaboration among sites. 2) Use of techniques gleaned from past research. 3) Awareness of new trends emerging in the field such as texting and social networking.
Conclusions: Successfully addressing recruitment and retention issues are core to our research success.
Related protocols: CTN-0047
This presentation, part of a panel at the Society for Clinical Trials annual meeting in 2012 focusing on ethical, regulatory, recruitment issues in vulnerable populations, covers the basic definitions and guidelines for including participants who are considered “prisoners” in substance abuse treatment research. In order to conduct research with prisoners, there are several additional, potentially complex steps that must be undertaken with the researchers’ institutional review board of record. Used as a practical example, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders,” is discussed, as approximately 35% of participants at baseline were either mandated or referred for treatment by the criminal justice system (a handful even wearing monitoring bracelets). In any trial, regardless of whether you have approval to conduct research with prisoners, the study must have procedures in place to determine if a participant is indeed a prisoner. Though this can be straightfoward if the participant is in a detention facility, there are a small number of cases where participants reside in the community but are considered a prisoner under the definition of the Office of Human Research Protections (OHRP). For CTN-0044, this mean the development of a screening procedure that asked a simple question about house arrest and followed-up with additional probes if necessary (for participants in this protocol, even those wearing ankle monitors were not officially considered “prisoners” because while their movements were restricted, they were allowed to come and go of their own accord to the treatment facility). The presentation provides an in-depth look at the issues surrounding research with prisoners, including the importance of including individuals who become incarcerated during a study to reduce bias.
Related protocols: CTN-0044
This 90-minute webinar, produced by the National Drug Abuse Treatment Clinical Trials Network (CTN) Clinical Coordinating Center for CTN members and the public, discusses recommended techniques to assure and/or improve treatment adherence. The discussion includes ways that adherence problems show in clinical settings, factors affecting adherence, and the impact of adherence on treatment outcomes. A major emphasis is on reviewing both clinical and systems strategies to improve adherence to study interventions throughout a research project.
The target audience is CTN members and other researchers and clinicians interested in substance abuse research in clinical settings.
Presented by Dennis Daley, PhD, LSW (Western Psychiatric Institute and Clinic, AT Node), and Allan Cohen, MA, MFT (Bay Area Addiction Research & Treatment, PR Node).
Additional Resources:
- Download slides (pdf)
Currently in the United States, pharmacological treatment of opioid addiction most commonly consists of replacement therapy with either methadone or buprenorphine/naloxone (bup/nal). Several clinical trials from the NIDA Clinical Trials Network have demonstrated the effectiveness of bup/nal in a variety of treatment settings and populations. Most recently a multi-site, open label, Phase IV study randomized 1269 participants in federally licensed opioid treatment programs to receive either six months of methadone or six months of bup/nal (CTN-0027, “START”).
The primary outcomes of the study focused on parameters of liver function; 731 participants completed the study. Worsening of indices of liver health was rare and did not differ by medication condition. Participants in the bup/nal group had poorer treatment retention than did participants on methadone. Adoption of bup/nal treatment in licensed opioid treatment programs will require additional efforts towards treatment retention.
Related protocols: CTN-0027
Historically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants. This study examined gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials. Reports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s). Analysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants.
Conclusion: The participation and ongoing retention rates of 70-80% did not differ by race/ethnicity or gender. However, participation and retention rates increased significantly with age. These results highlight the need to investigate the reason(s) why younger adult rates of participation are lower.
Underrepresentation in clinical trials limits the extent to which ethnic minorities benefit from advances in substance abuse treatment. The objective of this article is to share the knowledge gained within the Clinical Trials Network (CTN) of the National Institute on Drug Abuse (NIDA) and other research on recruiting and retaining ethnic minorities into substance abuse clinical trials.
The article includes a discussion of two broad areas for improving inclusion: community involvement and cultural adaptation. CTN case studies are included to illustrate three promising strategies for improving ethnic minority inclusion: respondent-driven sampling, community-based participatory research, and the cultural adaptation of the recruitment and retention procedures. The article concludes with two sections describing a number of methodological concerns in the current research base and a proposed research agenda for improving ethnic minority inclusion that builds on the CTN experience.