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May 8, 2019

Call for Papers: JSAT Issue Celebrating CTN's 20th Anniversary!

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JSAT coverSubmit one-page concept by May 31, 2019

The Center for the Clinical Trials Network is pleased to announce plans for a Journal of Substance Abuse Treatment Supplement reviewing the first two decades of the CTN with a focus on the past 10 years.

Dennis McCarty (Western States) and Dennis Donovan (Pacific Northwest) have volunteered to serve as guest editors.

The issue will reflect on the development of the CTN with commentary, and will include integrative summaries of the work the CTN has supported to close the gap between practice and research for the treatment of drug use disorders. A point of emphasis will be the extension of CTN from specialty addiction treatment services to general medical settings and healthcare systems. An additional focus will be research embedded in clinical care which utilizes pragmatic designs, leverages existing clinical staff, and evaluates strategies or approaches for advancing evidence-based care that can be sustainably implemented and disseminated in these settings.

To participate in the issue, email a one-page concept of potential papers by Friday, May 31st to Dennis McCarty (mccartyd@ohsu.edu) and Dennis Donovan (ddonovan@uw.edu), with a copy to Udi Ghitza (ghitzau@nida.nih.gov) and Landhing Moran (landhing.moran@nih.gov) in the Center for the Clinical Trials Network, for review and approval to proceed before drafting a full manuscript. CTN policy requires papers to be reviewed in the CTN publication committee before submission to JSAT. All manuscripts submitted to JSAT will undergo peer review.

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FDA Safety Announcement: Serious Harms Reported After Sudden Discontinuation of Opioid Medications

FDA logoThe FDA has released a new Safety Announcement identifying harms reported from sudden discontinuation of opioid pain medications and requiring label changes to guide prescribers on gradual, individualized tapering.

Reported harms include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

Read (and share!) the announcement here. The document includes information about safe tapering of opioid medicines for both health care providers and patients.

CTN Trial Progress

GraphRandomizations for Active Studies as of the May 7 trial Progress Report.

CTN-0067 - CHOICES Scale-Up. Enrolled 112

CTN-0068 - ADAPT-2 for Methamphetamine Use Disorder. Enrolled 403

CTN-0069 - OUD in the Emergency Department. Enrolled 486

CTN-0075 - Physician-Pharmacist Collaboration - OUD
Enrolled 76

CTN-0079 - ED-CONNECT
Enrolled 47

Total randomizations in active trials: 1124

 

This project is supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute, but the information on this site has not been reviewed by NIDA and does not necessarily reflect the views of the Institute.


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News from the Nodes

Northeast Node

Northeast Node

The Northeast Node is pleased to announce CTN-0103, entitled “Expanding Clinical Research Training on Implementing the Evidence-based Hub and Spoke Model of Medication-Assisted Treatment for Opioid Use Disorder.”

The Vermont Hub and Spoke Model (VT HSM) of substance use disorder care allows providers to initiate medication treatment for persons with opioid use disorder with assistance from local opioid treatment programs (Hubs) and then support ongoing care of patients through office-based treatment (Spokes) (with flexible movement back into Hubs for patients in need of additional stabilization).

The Node will collaborate with its partner, the New Hampshire (NH) Citizens Health Initiative, that helps lead the Northern New England (NNE) Project ECHO (Extension for Community Healthcare Outcomes) Network across ME, NH, and VT. The NNE ECHO is an expansive collaborative designed to implement a regional network of telehealth services for sharing of knowledge from multidisciplinary expert mentors and teams across a virtual network using the Project ECHO model. This model uses web-supported case-based learning to provide direct education and support to clinicians and communities addressing the opioid epidemic to improve access, care delivery, outcomes and health.

As part of this ongoing teleECHO learning collaborative (LC), CTN-0103 will expand clinical research training in evidence-based quality improvement (QI) methods that were central to delivering and sustaining science-based medication-assisted treatment for opioid use disorder (MOUD) within the VT HSM with fidelity.

To do so, participating primary care practices will be trained in the use of a study-developed toolkit of research and evaluation methods that have been shown to be critical to the impact of the HSM, and the Northeast Node will systematically evaluate the impact of this training. The toolkit will initially be offered to NH providers in the NNE Project ECHO, with the potential to expand to other states.

In addition to the learning provided by the ECHO modules, the study will train participating practices to systematically track standardized outcome metrics and regularly share their practice’s data with other LC members. Practices can then use this information to refine their care model over time, with goals of improving fidelity to best practices for MOUD, promoting optimal patient outcomes, targeting areas for improvement, and giving practices additional tools to sustain the learning provided in the ECHO.

Over the course of the ECHO LC, the study will measure changes in providers’ knowledge about best practices for MOUD, their comfort in caring for OUD patients with MOUD, and their performance on relevant standardized outcome metrics.

Overall, this initiative will support training in clinical research and evaluation methods to best implement and sustain the evidence-based HSM of MOUD. TeleECHO offers considerable promise for supporting a broad learning collaborative/training mechanism within the HSM among geographically-dispersed providers, such as those in rural NH.

You can follow the Northeast Node on Twitter and Facebook.



Texas Node

Northeast NodeIt’s springtime in Texas and we are thrilled to announce that we have reached our target of 400 randomizations for ADAPT-2 as of 4/8/2019!

We want to offer thanks and congratulations to all of our dedicated ADAPT-2 sites for their hard work! Our teams continue to improve across all performance metrics and now that enrollment is closed they will focus heavily on retention and medication adherence.

We want to recognize some of our sites for their outstanding achievements on the ADAPT-2 trial. Congrats to UCLA and UT Southwestern, who have had consistently high availability of primary outcome data and overall treatment exposure!

We also want to recognize SURU for being a very close runner up to UCLA and UT Southwestern. Congrats to CODA for being the first to reach their site’s randomization target! Well done, everyone! As the weather gets warmer all our sites will continue utilizing creative strategies for keeping active participants engaged and help them complete the study with flying colors!

Happy spring everyone!

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From the ATTC & SAMHSA

ATTC logoATTC/NIATx Blog Posts:

Why Understanding and Involving the Customer Matters in Behavioral Health
Mat Roosa, LCSW-R, NIATx Coach

ECHO-CMU for ATTC 25th Anniversary: SEA-HATTC's Expansion of New Learning Strategies
ATTC Network

Workplace Learning: Helping Practitioners Work Wiser
Nancy Roget, Joyce Hartje & Terra Hamblin. Pacific Southwest ATTC

New at SAMHSA:

EBP Resource Center
Evidence-Based Practices Resource Center
The new SAMHSA Evidence-Based Practices Resource Center aims to provide communities, clinicians, policy-makers, and others in the field with the information and tools they need to incorporate EBPs into their communities or clinical settings. Find a collection of scientifically-based resources for a broad range of audiences, including Treatment Improvement Protocols, toolkits, resource guides, clinical practice guidelines, and other science-based resources.

Find the Resource Center here!

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CTN Resource Updates

ATTC/WSN LogoCTN Investigator Toolbox

The CTN Investigator Toolbox is an online resource for CTN investigators. It contains detailed information and guidance documents to help investigators navigate the CTN study process from protocol concept and development through protocol implementation and close-out.

The Clinical Coordinating Center (CCC) recently posted the following new documents:

  1. Informed Consent. This document is intended to provide guidance to CTN investigators and their teams on the rules for developing the Informed Consent Form (including federal and CCTN-specific requirements), the CTN-specific ICF review process, and CTN requirements for informed consent documentation and storage. Make sure to check out the Informed Consent document in the Protocol Development section of the Toolbox.

  2. Research Advisory Panel of California (RAP-C). This document provides more details to investigators and study teams conducting certain types of trials involving illicit substances in the state of California. Check out the RAP-C document under Pre-Implementation>Regulatory in the Toolbox.

The Data and Statistics Center (DSC) recently posted the following new document:

  1. PhenX Assessments (2019): Qualifying CTN trials are expected to collect information on all PhenX Core Tier 1 measures, which include measures of alcohol and substance use, vital signs/BMI, demographics, self-report of HIV testing, quality of life, and tobacco use history. More information on these measures and example Case Report Forms from the DSC can be found in the PhenX document under Pre-Implementation>Assessments in the Toolbox.

For help logging into the Toolbox, questions, or comments, or if you have suggestions for items you’d like to see added to the Toolbox, please contact Dee Blumberg (dblumberg@emmes.com) Julia Collins (jcollins@emmes.com).

ATTC/WSN LogoCTN Policies & Procedures Guide

An updated version of the CTN Policies and Procedures Guide (v. 8.0) is now available!

It is posted on the CTN Website: https://ctndsc2.com/ under the CTN Documents tab.

Some of the updates in this version include the addition of Data Science Studies (Section 3.1), clarification of PRB and DSMB roles as well as Node PI and Site PI roles throughout the document, expansion of the DSMP (Section 6.1), added descriptions to the Data Status Reports (Section 7.3), and clarification of timing and procedures involved in database lock (Section 8.0).

For questions or difficulty accessing the document please contact Dee Blumberg (dblumberg@emmes.com).

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Upcoming Events

AHSR logo2019 Addiction Health Services Research Conference, October 16-18, 2019:
The 2019 AHSR conference website is now live, with updates on the call for abstracts, registration, and the meeting venue. Check it out and start making your plans here!

Workshop: Interpersonal Violence Syndemics and Co-Occurring Epidemics - Preventing Violence in the Context of Opioid Misuse, Suicide, Social Disparities, and HIV (National Academy of Sciences)
May 16-18, 2019, Washington DC. Will be live-streamed and recorded for those who cannot attend. Find out more here. . .

Also of Interest

Hazelden Betty Ford Seeking New Director for Butler Center for Research
This senior leadership role will lead Hazelden's institutional and clinical research activities to improve treatment effectiveness and fulfill the goals of the organization's strategic plan. Find out more here. . .

NIH Template for Research Protocols Measuring Social or Behavioral Outcomes in Humans
This new protocol template will help behavioral and social science researchers better prepare research protocols for human studies measuring social or behavioral outcomes. Find out more here. . .

     

Published by the CTN Dissemination Library of the Pacific Northwest Node
Alcohol & Drug Abuse Institute, University of Washington

This project is supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol & Drug Abuse Institute, but the information on this site has not been reviewed by NIDA and does not necessarily reflect the views of the Institute.

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