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Virtual CTN Steering Committee Meeting: March 11, 1-5pm ET
The National Institute on Drug Abuse (NIDA) Center for the Clinical Trials Network (CCTN) is hosting a virtual Quarterly Steering Committee Meeting on Tuesday, March 11, 2025 from 1:00 – 5:00 p.m. Eastern. View agenda | Register for the meeting Once registered you will receive the Zoom information, including an option to download a calendar invitation. If you have any questions about the meeting logistics, please contact CTNSupport@sdsolutionsllc.com. Individuals with disabilities who need sign language interpreting and/or other reasonable accommodations to participate in this event should contact Sean Randol at (202) 258-3638 or srandol@sdsolutionsllc.com or through the Federal Relay (1-800-877-8339). Requests should be made at least five business days in advance of the event.
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CTN T&I SIG Session: A Pragmatic Measure of Context at the Organizational Level: The IFASIS (March 18, 9am PT)
Title: A Pragmatic Measure of Context at the Organizational Level: The Inventory of Factors Affecting Successful Implementation and Sustainment (IFASIS)Date/time: March 18, 2025, 9-10am PTSpeaker: Helene Chokron Garneau, PhD, MPH (Senior Research Scientist at Stanford University School of Medicine and co-Director of the Center for Dissemination and Implementation At Stanford (C-DIAS). Download/share the flyer (image file). Successful implementation and sustainment of interventions is heavily influence by context. Yet the complexity and dynamic nature of context make it challenging to connect and translate findings across implementation efforts, limiting potential replicability and utility. The Inventory of Factors Affecting Successful Implementation and Sustainment (IFASIS) was developed to be a pragmatic, quantitative, organizational-level assessment of contextual factors. The intention is to characterize context with a measure that may enhance replication and reproducibility of findings beyond single implementation case studies. This talk from the CTN Translation and Implementation (T&I) SIG will provide an overview of the development and validation of the IFASIS, as well as examples of its practical utility. To join the session, contact Elena Rosenberg-Carlson at rosenbee@stanford.edu
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Update from the CTN CCC and DSC
The CCC and DSC are pleased to announce a new resource on the CTN TPR Website: The CTN Sample Document Repository, a reference library of over 100 sample study documents developed by a working group of Node Coordinators and Project Directors from recent CTN studies. Sample study documents consist of training materials, recruitment and retention documents, as well as sample documents required for Protocol Review Board submission, among others. The CTN Sample Document Repository is a collaborative effort between the CTN Nodes, CCC, and DSC. Sample documents were developed and submitted by CTN Investigators and their study teams. Partnering with Dagmar Salazar from the CCC, a working group of Node Coordinators and Project Directors across four Nodes reviewed all submissions and collectively selected documents for inclusion in the Repository. The Repository is intended to serve as a valuable tool for project directors, study investigators, and especially new protocol teams leading CTN studies. Questions on specific documents should be directed to the corresponding contact person listed on the contact sheet posted to the Repository. The Repository can be found on the landing page of the CTN TPR website, by selecting “CTN Sample Document Repository” from the Main Menu Links. Many thanks to all who contributed to this effort, including all study teams who submitted their documents, and the working group members from the CTN Nodes past/present: Chantal Lambert-Harris, Phoebe Gauthier, Gina Gregovich, Sarah Farkas, Sarah Meyers-Ohki, Susan Sonne, Bethany McLeman, and Paulette Baukol.
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News from the Health System Node: Spotlight on Gwen Lapham, PhD, MPH, MSW
Spotlight on Health System Node Investigator – Gwen Lapham, PhD, MPH, MSW CTN studies often have many important secondary findings and Dr. Lapham, a CTN investigator in the Health Systems Node, has been making sure these get published rapidly. In 2024, Dr. Lapham led a paper on Year 3 outcomes of the PROUD Trial (CTN-0074) in JAMA Network Open, showing that the benefit of the PROUD nurse care manager intervention more than doubled during year 3 (compared to years 1-2 in the main results paper) with significant benefit in 4 of 6 health systems (compared to 2 in main results) suggesting that main results were early in implementation. Dr. Lapham, who led the CTN-0077 study (Medical Cannabis in EHRs), also oversaw 2 secondary papers this year, including one in the Journal of General Internal Medicine that showed the prevalence of cannabis use disorder increased with greater frequency of cannabis use reported by patients in the clinical setting. She also led a paper for CTN-140 published in the Journal of Addiction Medicine that identified predictors of participation among pregnant individuals who use cannabis in Kaiser Permanente Northern California’s Early Start program – a prenatal substance use assessment, counseling, and treatment program. The study found most pregnant individuals with prenatal cannabis use engaged in the program, though opportunities to improve care gaps remain. CTN-0074: Nurse Care Management of Opioid Use Disorder Treatment After 3 Years: A Secondary Analysis of the PROUD Cluster Randomized Clinical Trial. Lapham GT, Hyun N, Bobb JF, Wartko PD, Matthews…
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News from the Appalachian Node
The Appalachian Node has received a notice of award for funding for the next seven years (FY25 – FY32). We are excited to welcome to our newest partners, University of Maryland Baltimore and the PATH Network.
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New in the Library (January-February 2025)
Here are the latest items added to the CTN Dissemination Library for January – February 2025 (this post will be updated as new items come in): Predictors of Participation in Prenatal Substance Use Assessment, Counseling, and Treatment Among Pregnant Individuals in Prenatal Settings Who Use Cannabis. Lapham GT, et al. Journal of Addiction Medicine 2024 (in press). (CTN-0140) Optimizing Retention Strategies for Opioid Use Disorder Pharmacotherapy: The Retention Phase of the CTN-0100 Trial (RDD). Shulman M, et al. Contemporary Clinical Trials 2025;107816 (in press). (CTN-0100) Age, Period, and Cohort Effects in Alcohol and Other Substance Use: Implications for Health and Prevention (webinar). Keyes KM. Youth Special Interest Group (SIG) webinar, January 2025. Effects of Randomization to Buprenorphine or Naltrexone for OUD on Cannabis Use Outcomes: A Secondary Analysis of the X:BOT Trial. Shulman M, et al. Drug and Alcohol Dependence 2025 (in press). (CTN-0051) Evaluating Tests for Cluster-Randomized Trials with Few Clusters Under Generalized Linear Mixed Models with Covariate Adjustment: A Simulation Study. Qui H, et al. Statistics in Medicine 2024;43(2):201-215. Posted on January 19, 2025; Updated on February 11, 2025
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CTN-0096 (Tribal MOUD): Notice of Data Lock Completion
Culturally Centering Medications for Opioid Use Disorder with American Indian and Alaska Native Communities (CTN-0096, Tribal MOUD) – Notice of Data Lock Completion Incorporating American Indian and Alaska Native (AI/AN) traditional practices and knowledge into healthcare can support AI/AN health. Despite higher rates of abstinence, AI/AN experience the highest rates of overdose mortality due to the ongoing impact of colonization, historical trauma, discriminatory policies, and under-resourced healthcare. Medications for opioid use disorder (MOUD; e.g., buprenorphine, methadone, naltrexone) are the most effective treatment for reducing opioid-related mortality. CTN-0096 (Tribal MOUD) was a two-phase formative implementation study with a stepped wedge design, grounded in community-based participatory research (CBPR) principles, with the aims to develop and test a program-level intervention to culturally center the delivery of MOUD in four healthcare/addiction specialty treatment sites serving AI/AN communities. In Phase I, a Collaborative Board (CB) guided intervention development which was also informed by Indigenous and Western implementation science frameworks. In Phase II, workgroups at each site participated in a six-month intervention delivered in three phases (explore, prepare, implement) and guided by two American Indian facilitators knowledgeable in implementation strategies and clinical best practices. The primary outcome, comparing pre-intervention to post-intervention, was the number of AI/AN clients initiated on to MOUD obtained through program electronic health records. We are delighted to share that CTN-0096 data lock was completed on December 13th, 2024. Preliminary outcomes will be forthcoming. The lead study team sends congratulations and a big thank you to our fantastic community research partners, collaborative…
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News from the Pacific Northwest Node
The Pacific Northwest Node of the NIDA Clinical Trials Network, located at the UW Addictions, Drug & Alcohol Institute and directed by Mary Hatch, PhD, and John Roll, PhD, had a very productive 2024, with 4 published papers and 4 more in the works! New Publications First, they recently participated in the publication of four papers from CTN-0082, Implementation Survey of PrEP and Opioid Use Related Services in STI Clinics and Community Based Organizations (CBOs), including two outcomes papers (first two listed here): The two outcome papers found that people who use opioids (PWUO) and substance using men who have sex with men (SU-MSM) are both interested in using PrEP. There were distinct factors associated with willingness to use two different types of PrEP formulations: daily oral and long-acting injectable (LAI). For SU-MSM, willingness to use daily oral PrEP was associated with condomless anal sex, less frequent non-injection drug use, and prior PrEP awareness and past use. Willingness to use long-acting injectable PrEP was associated with being Black, identifying as gay, being single, and higher injection drug use. For PWUO, education and condomless vaginal sex was associated with willingness to take daily oral PrEP, while only education predicted willingness to take LAI PrEP. Careful consideration for matching PrEP messaging to the specific audience is needed. PrEP promotion should expand beyond PWUO and SU-MSM to include people who are predominantly heterosexual and polysubstance-using with HIV risk, who were open to both formulations of PrEP. Coming Soon The Node also has…
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News from the Appalachian Node
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News from the Northeast Node: ED Treatment of OUD webinar (Feb 6, 9am PT)
Join the Northeast Node on February 6 (9am-10am PT) for the next installment in their Science Series: Emergency Department Treatment of Opioid Use Disorder: Innovation & Discovery. Opioid use disorder (OUD) took the lives of an estimated 107,543 people in the United States in 2023, yet medications to treat OUD are effective and widely available. Emergency departments are a 24/7/365 option for combating this crisis and saving lives. In this presentation, Dr. Gail D’Onofrio will discuss the evidence regarding initiation of buprenorphine in the ED, describe innovations in dosing and formulations (extended-release and high dose initiation), and discuss implementation strategies to improve uptake of evidence-based practices and integration into EDs across the country. Register here!
