CCTN Webinar: Xylazine Discussion Forum |
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Join the Center for the Clinical Trials Network (CCTN) on Tuesday, September 26, 2023 from 4:00-5:30pm ET for a virtual Xylazine Discussion Forum for CTN investigators.
Speakers Jeanmarie Perrone, MD (University of Pennsylvania) and Rachel Haroz, MD (Cooper University and Rowan University) will highlight the emerging threat of xylazine in the U.S. illicit drug supply, summarize emerging practices for treating people taking xylazine-adulterated opioids, and discuss research gaps and opportunities identified in a recent meeting of experts convened by NIDA.
CTN researchers will be encouraged to participate in discussion and Q&A.
Register for the Xylazine Discussion Forum here! · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
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Recording Available for June's CCTN Webinar on FDA Basics & Essential Regulatory Compliance
New webinar recording available:
Research 101 Session 2: FDA Basics & Essential Regulatory Compliance
This webinar outlines the basics of FDA oversight and reviews other essential regulatory activities to successfully keep a study in compliance, including ongoing management and reporting requirements. The regulatory portion reviews essential regulatory activities, such as IRB approvals and informed consent requirements. Lastly, there is a discussion of current challenges and best practices when working on regulatory compliance.
Check out the recording here! |
CTN Trial Progress
 Randomizations for Active Studies as of the August 18 Trial Progress Report.
CTN-0080 - Enrolled 140
CTN-0096 - Enrolled 12
CTN-0098 - Enrolled 162
CTN-0099 - Enrolled 1636
CTN-0100
Discontinuation - Enrolled 176
Retention - Enrolled 870
CTN-0101 - Enrolled 202
CTN-0107 - Enrolled 150
CTN-0108 - Enrolled 97
CTN-0109 - Enrolled 23
CTN-0110 - Enrolled 13
CTN-0116 - Enrolled 115
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NIH Research Opportunity Announcements for N CREW Program (due Nov 1)
 NIH has published two Research Opportunity Announcements (ROAs) for the HEAL-funded Native Collective Research Effort to Enhance Wellness (N CREW) Program, available on the N CREW Website. Applications are due November 1.
- ROA OTA-23-007 solicits applications from Tribes and Native American Serving Organizations (T/NASOs) for the planning, development, piloting, and/or implementation of research and/or data improvement projects. Projects must explicitly include a focus on overdose, substance use (including opioids or stimulants), or pain management. They may also include related factors such as mental health or wellness, among others, to support positive health outcomes in Native American communities. T/NASOs are defined as federally or state recognized Tribes and organizations with a core mission to serve and/or a track record in serving Native Americans and that are poised to reach this population.
- ROA OTA-23-008 solicits applications from T/NASOs and Ally Organizations to form a Native Research Resource Network. Ally Organizations are defined as organizations with a demonstrated track record of partnering successfully with Native American communities. The network will provide comprehensive training and resources to support T/NASOs in real-time as they lead research and data improvement projects. Components of the network will also provide coordination of resources, reporting, and cross-site activities.
Questions about this opportunity can be directed to NCREW@nih.gov. Additional information is also available on the N CREW Website.
Register for the N CREW Program Webinar: Instructions for Using eRA Commons and ASSIST. Wednesday August 30th at 1:30pm-3pm EDT.
Register for the N CREW Program Webinar: Questions and Answers. October 3rd at 2pm-3pm EDT.
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Data Management and Sharing Plan Template Now Available in the Investigator's Toolbox
 In collaboration with the CCTN, the Data and Statistics Center (DSC) at Emmes has developed a template Data Management and Sharing (DMS) Plan for CTN studies.
This was developed as a tool for CTN investigators following implementation of NIH’s final Data Management and Sharing policy (effective January 25, 2023), which requires that NIH-funded studies have a plan that outlines how scientific data and accompanying metadata will be shared. While the templated language assumes DSC support of data collection, this may be modified as needed to accommodate studies for which the DSC does not provide that support. Study-specific DMS Plans will be prepared by investigators and submitted at the time of initial protocol review for review by NIDA.
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Request for Letters of Interest: NIAAA: Alcohol Pharmacotherapy Evaluation Program (APEP)
The National Institute of Alcohol Abuse and Alcoholism (NIAAA) is seeking letters of interest (LOIs) for promising medications (both novel compounds and repurposed medications) to evaluate their efficacy and safety in Phase 1 and 2 clinical trials for the treatment of alcohol use disorder (AUD). Clinical trials will be supported by a NIAAA contract and conducted by NIAAA’s Alcohol Pharmacotherapy Evaluation Program (APEP). This program includes studies conducted by the NIAAA Clinical Investigations Group (NCIG), Human Laboratory Program (HLAB), and Alcohol Interaction program (ALC InX). Studies supported under this mechanism are designed by the APEP team and utilize established paradigms and protocols developed in collaboration with the medication’s stakeholders. APEP trials are generally completed within 1.5 years and are conducted under Good Clinical Practice (GCP).
Notice Number: NOT-AA-23-016
Please download and complete the LOI form, and email it to Dr. Daniel Falk at falkde@mail.nih.gov no later than September 15, 2023.
For novel compounds, inclusion of an Investigator’s Brochure is strongly recommended. If the LOI contains confidential information, please contact niaaatechtransfer@mail.nih.gov for a non-disclosure agreement and instructions on how to securely email the LOI prior to submission. Contact Dr. Falk with any other questions.
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News from the Western States Node
 Join the CTN Western States Node and the Northwest and Pacific Southwest ATTCs for our next webinar:
Not Too Much, Not Too Often, and Not Too Many: The Results of the First Large-Scale International Project to Develop Lower-Risk Gambling Guidelines
September 6, 11am-12:30pm PT
Advice about how to gamble "responsibly" is widely promoted in many jurisdictions. However, until now, there has been no evidence-based, specific advice for people who gamble who want to reduce their risk of gambling harms. In 2016, the Canadian Centre on Substance Use and Addiction began the first large scale international, comprehensive, multimodal project to develop evidence based Lower-Risk Gambling Guidelines (LRGGs). Borrowing the same collaborative, evidence-driven approach used to develop the nation's Low Risk Alcohol Drinking Guidelines, the LRGG initiative produced a set of workable, evidence-based quantitative limits on gambling behavior to help people make informed decisions about their gambling. This project included collaboration with researchers in eight other countries, analysis of epidemiological data from over 60,000 people who gamble, consultation with a pan- Canadian, multi-sectorial advisory committee made up of over 20 members, input from over 10,000 regular people who gamble via a national online survey, and qualitative data obtained from focus groups and interviews.
This presentation from David Hodgins, PhD and Matthew Young, PhD will describe key deliverables from the LRGG project including the lower-risk limits for expenditure, frequency and number of types of games. It will also present a self-assessment quiz, a suite of posters and other knowledge mobilization tools that are freely available to those who with use or promote the guidelines.
1.5 CME or CE credits available. For more information on types of credits and accreditation, view the flyer.
Register here!
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Update from CTN-0100
In June, the CTN-0100 Project Team launched a month-long BINGO challenge aimed at boosting recruitment and retention across the 18 study sites. BINGO squares included hitting (or exceeding!) randomization targets for the month, reuniting with a missing participant, completing two randomizations in one day, and establishing a relationship with a new referring partner.
The Operation PAR site (pictured) from the Florida Node Alliance was the first site to “BINGO,” just 6 days into the challenge! Five additional sites achieved “BINGO” by the end of the month.
We thank all of the CTN-0100 sites for their continued diligence on this project!
Check out the BINGO sheet used for this challenge here!
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NIH HEAL Headliners Webinar Series
The NIH HEAL Initiative® is pleased to announce the next HEAL Headliners webinar, "More Than a Number: Data-Driven Solutions for Pain and Addiction," on Friday, September 8, 2023, from 2:00 to 3:00 p.m. ET. The webinar will explore how two large HEAL-funded research studies are leveraging the power of data to develop effective interventions for pain, addiction, and opioid overdose.
Presenters:
Meredith C.B. Adams, M.D., M.S., Wake Forest University School of Medicine
HEAL Project: Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC)
Marc LaRochelle, M.D., M.P.H., Boston Medical Center
HEAL Project: HEALing Communities Study-Massachusetts
Moderator: Jessica Mazerik, Ph.D., Director, HEAL Data Ecosystem
Register now for the September webinar.
In case you missed it, the August HEAL Headliners webinar, “Mapping the Path to Relief: Improving Pain and Opioid Use Disorder Through Neuromodulation,” is now available online.
This webinar explored research progress in neuromodulation for pain and opioid use disorder, focusing on new technologies tailored to meet the needs of patients.
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 New in the CTN Dissemination Library
Castillo F, et al. Risks of Returning to Opioid Use at Treatment Entry and Early in Opioid Use Disorder Treatment: Role of Non-Opioid Substances. Drug and Alcohol Dependence 2023 (in press). CTN-0027, CTN-0030, CTN-0051
Parchman ML, et al. Supporting Practice Facilitators in a Learning Health Care System [commentary]. Permanente Journal 2023:23.035
Kidd JD, et al. Sexual Orientation Differences Among Men in a Randomized Clinical Trial of Extended-Release Naltrexone and Bupropion for Methamphetamine Use Disorder. Drug and Alcohol Dependence 2023; 250:110899. (CTN-0068)
Trombello JM, et al. Psychometrics of the Concise Health Risk Tracking Self-Report (CHRT-SR16) Assessment of Suicidality in a Sample of Adults with Moderate to Severe Methamphetamine Use Disorder: Findings from the ADAPT-2 Randomized Trial. Neuropsychiatric Disease and Treatment 2023; 19:1443-1454. (CTN-0068)
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Moving Beyond "Spaghetti Suppers" to Fund Peer Support Services the Classroom to Improve Intensive Technical Assistance Efforts