NIDA Resources to Help People with SUD During the Pandemic

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.

News from the Nodes

Health Systems Node

Updates from the PROUD Trial (CTN-0074):

The Boston Training and Technical Assistance Team (TA Team) continues to provide weekly video and other ad hoc support for the nurse care managers (NCMs). The focus has been on sharing resources and recommendations for adapting care to telehealth and virtual care during this rapidly changing environment with COVID-19, and general support to the NCMs during these challenging times. A huge thank you to the NCMs and the TA Team!

The DSMB report (using data pull 4 data) was presented to the CTN DSMB on April 29th.

We are preparing for data pull 5, where we will collect the main trial outcome data.

We want to welcome Kaiser Permanente Colorado and Kaiser Permanente Northwest on board as exemplar sites, as they will be participating in data pull 5. As a secondary aim, we will use data from the exemplar sites to conduct observational analyses to compare outcomes of the PROUD intervention to outcomes of exemplar sites (i.e. “other innovative models of treating OUDs in primary care”).

Chart abstraction to resolve buprenorphine orders that appear as duplicates in the data is complete at some sites and ongoing at others. For sites that completed the abstraction, this resulted in resolving duplicates into groups of “data anomaly” or “unique order”.

The statistical analysis plan (SAP) is currently being updated to include additional descriptive analyses and analytic plans for the objectives included in the protocol that were not included in the original version.

The PROUD Operations team approved all 6 intervention sites to be funded through February 2021 to continue the intervention during the 1-year extension period. The goal of this decision was to support stability during the challenging COVID times for our patients, research teams and clinical teams. Before COVID, there was a contingency in place for some sites to increase their number of patients by June to receive funding past August 2020 during the extended intervention period. This contingency has been removed.

New funding: A PCORI methods grant on identification bias has been funded. It is motivated by the PROUD Trial to develop innovative and generalizable causal inference methods and models to address pos-randomization confounding in the design and analysis of cluster randomized trials, and will use PROUD secondary data after the trial is complete.

Updates from the CTN-0084 trial:

CTN-0084, Developing a Prescription Opioid Registry across Diverse Health Systems, is an electronic health record-based prescription opioid registry project, currently in its final year, that includes 10 health systems in the Health Systems Node (HSN), as well as consultants from other nodes. To date, we have developed and tested the algorithms that each site utilizes to extract data from each site’s electronic health record data warehouse. We’ve developed 27 distributed data tables at each site encompassing several domains: pharmacy utilization, diagnoses, subjects, health care utilization, procedures, enrollment, cancer status, person time, mortality, provider specialty, and geocoded data.

Almost all sites have completed analyses that examine trends in opioid prescribing by population demographics from 2012-2018 using an interrupted time series approach. In consult with site PIs and other experts in the field, we developed an algorithm for assessing opioid tapering using EHR data to address potential adverse events associated with opioid tapering. The lead site, Kaiser Permanente (KP) Northern California, successfully implemented these analyses, and they are being rolled out to the other health systems.

KP Colorado is leading analyses of length of buprenorphine use and its association with mortality. To date, they have developed an EHR-based cohort in their health system of patients diagnosed with OUD, and a sub-cohort of those individuals who initiated and discontinued buprenorphine treatment. They have examined treatment patterns generally, including length of buprenorphine treatment, number of treatment episodes, insurance coverage, and mortality rates. A formal medical record review to assess potential for measurement error and informative loss to follow-up within the electronic health record is ongoing. Once algorithms are finalized at KP Colorado, analyses on data from the other health systems will be conducted.

Ohio Valley Node

The CTN-0080 (MOMs) team has its first published manuscript for the study. The writing team, led by Dr. Theresa Winhusen (OVN Node PI and CTN0080 LI), successfully submitted “Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations” to Contemporary Clinical Trials.

The journal has provided a link to the manuscript which can be accessed without cost any time before June 24, 2020.

Congratulations to Dr. Winhusen and the CTN-0080 Team!

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Pacific Northwest Node

Evergreen Treatment Services (ETS) in Seattle is one of the Pacific Northwest Node's longest and staunchest CTP partners. Given that Seattle experienced the first COVID-19 outbreak in the nation, ETS drafted, sought, and implemented exceptions to opioid use disorder (OUD) treatment regulations that ultimately led to SAMHSA's current guidelines. An interdisciplinary team of researchers and clinicians at ETS published a brief paper on this topic in AIDS and Behavior (available free here).

The lead author, Michelle Peavy, got her start as a CTN Research Coordinator at ETS in the early years of the Pacific Northwest Node. She went on to earn her PhD in Clinical Psychology, did her post-doctoral training at VA Puget Sound, returned to the PN Node as a CTN Research Fellow, and then went back to ETS as their Research and Training Manager. It's a great example of the way the CTN can launch a career!

We are proud of ETS and Michelle's membership in the Pacific Northwest Node and their long-standing CTN collaboration!

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Protocol Update: CTN-0100

The CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) protocol is a large clinical trial comprised of a Retention Phase (with participants engaged for up to 2 years) and a Discontinuation Phase (with participants engaged for up to 18 months).

The Lead Investigators on this study are Drs. Ned Nunes (New York Node), John Rotrosen (New York Node), and Roger Weiss (New England Consortium). For more information, please contact RDD at rdd@nyulangone.org.

The RDD sites were selected in March 2020; 18 sites from 13 Nodes will participate in 2 Waves. We are currently working on site and node budget estimates and finalizing the process for local IRBs to cede to the BRANY sIRB.

Timelines are uncertain due to COVID-19. The DM meeting will be held remotely the week of June 1st with an eye to a start in the Fall of 2020.

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From the CTN DSC

The DSC has developed and posted to the CTN website (ctndsc2.com) a new User's Guide to assist CTN investigators and research staff with accessing and using common features of the website, and addressing commonly asked questions.

A link to the User's Guide can be found at the bottom of the website's front page. An existing account is not required in order to access the User's Guide, as this document provides guidance for requesting access.

For additional questions or comments, or if you have suggestions for items you'd like to see added to the User's Guide, please contact Kathryn Hefner, khefner@emmes.com and Hector Roque, hroque@emmes.com.