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September 29, 2017   

CTN-0044-Evaluated Digital Tool Receives FDA Approval



NIDA AwardsPear Therapeutics, producer of a number of digital therapeutic tools, announced this month that the FDA has approved their marketing of a smartphone-based tool called "reSET®" for the treatment of patients with substance use disorder (SUD).

This is the first time the FDA has cleared a prescription digital therapeutic with claims to improve clinical outcomes in a disease. (Prescription digital therapeutics are clinically validated, FDA-cleared software applications designed to enhance clinical outcomes.)

ReSET® is based on the computer-delivered Therapeutic Education System (TES) intervention evaluated by NIDA Clinical Trials Network protocol CTN-0044, Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders. In that study, 399 patients with SUD across 10 treatment centers received either treatment-as-usual (standard face-to-face counseling) or a reduced amount of face-to-face counseling supplemented with the TES intervention.

Results found that use of the computer-delivered TES intervention more than doubled the rate of abstinence compared to standard, face-to-face counseling. In a sub-group analysis of non-abstinent patients at study start, a poor prognostic indicator, patients randomized to the digital therapeutic demonstrated an almost five-fold improvement in abstinence.

"In 2016, an estimated 20.1 million people aged 12 or older needed substance use disorder treatment according to the Substance Abuse and Mental Health Services Administration," said Edward V. Nunes, MD, Professor of Psychiatry at Columbia University Medical Center and independent Lead Investigator on the clinical study submitted to the FDA. "The clinical outcomes demonstrated in the reSET® pivotal study are remarkable. Clinically-validated digital therapeutics may become a cornerstone of future treatment."

reSET® provides cognitive behavioral therapy as an adjunct to a contingency management system for patients 18 years or older who are currently enrolled in outpatient treatment.

Find more information about reSET® here.

CTN Trial Progress

GraphStudy results for Open Studies as of the September 28 trial Progress Report.

CTN-0064 - Linkage to HCV Care. Enrolled 113

CTN-0068 - ADAPT-2 for Methamphetamine Use Disorder. Enrolled 50

CTN-0069 - OUD in the Emergency Department. Enrolled 47

Total Enrolled in all Studies: 24,316

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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New from the CTN Dissemination Library

Testing and Linkage to HIV Care in China: A Cluster-Randomized Trial. Wu Z, et al. Lancet HIV 2017 (in press). Get article. . .

Find it in the Library slideSend Us Your Presentations and Posters!

We'd love to feature your presentations and posters about CTN-related research in the CTN Dissemination Library! If you've presented about the CTN recently, please send us your slides or poster file!

If you're going to be presenting in the future, remember that we can create a URL for your slides/poster on the Library site in advance that you can pass long to your audience the day of the presentation -- so they know right where to go to get a copy of your slides. We can even give you a PowerPoint slide with the URL on it that you can just pop into the end of your slidedeck. Easy!

Contact us at info@ctndisseminationlibrary.org.

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News from the Nodes

Greater New York

On Wednesday, September 13, 2017, the Greater New York Node, together with the CCTN hosted a half-day symposium at NYU's Washington Square campus "Harnessing Policy, Practice and Research to Address the Opioid Epidemic" that brought addiction experts from federal, state and local organizations, and academia.

The event was attended by 85 participants representing many professional disciplines, organizations, foundations and treatment settings.

The meeting began with a very brief overview of the epidemic by John Rotrosen (NYU) followed by a welcome from Betty Tai (NIDA CCTN). Carlos Blanco (NIDA DESPR) presented a comprehensive report on the extent of the epidemic, NIDA's interests, special research focus and funding opportunities.

The program continued with reports from Richard Saitz (Boston University) and Beth Tanzma (Vermont Blueprint for Health) on how Massachusetts and Vermont are addressing the epidemic. Their presentations emphasized the importance of collaborative efforts among treatment providers, communities, policy makers, and state administrators.

Presentations on New York State and New York City efforts followed. We heard from Kenneth Leonard (Research Institute on Addictions) on addressing the capacity/need gap for medication assisted treatment for opioids in high need NY State regions.

Hillary Kunins (Bureau of Alcohol and Drug Use, NY City Department of Health and Mental Hygiene) spoke about the city’s public health approach, and Luke Bergmann (Office of Behavioral Health, NY City Health + Hospitals) presented on essential care, how NYC’s public hospital system is responding to the crisis.

Samuel Ball (Yale) led our discussion with a summary of our addiction crisis and the solutions and dissemination models presented by our colleagues. He emphasized the need for an overarching public health model and response but also the ongoing challenges faced by all stakeholders. Overall, the event was well received.

We thank all who attended and contributed to its success!

Texas Node

The ADAPT-2 study, CTN-0068, is a double-blinded, placebo-controlled study investigating the effectiveness and safety of a combination extended-release naltrexone plus extended-release bupropion for adults with moderate to severe methamphetamine use disorder.

The latest updates from the project:

  • All seven ADAPT-2 sites are working hard to increase recruitment and maintain participants in the study.
  • All sites have randomized at least 6 participants as of September 26thand the study is closing in on the N=50 mark!

The Texas Node is the lead node for the study, and the UT Southwestern team wishes to recognize the team at Hennepin/Berman Center (Northstar Node) for most improved recruitment (Gavin Bart, Nate Tessum, Deb Grillo, Ellie Wolinski, and Jaci Schloesser) and being the first to achieve the site monthly target of n=4 randomizations for the month of September.

We also wish to congratulate the UTHealth team in Houston for their creativity and persistence in tracking down all their participants after Hurricane Harvey!

Northeast Node

The Northeast Node kicked off this year’s academic Science Series on September 21, 2017, with a presentation by Dr. Emre Ertin, PhD, on "Behavioral sensing: An enabling technology for mobile health research." Dr. Ertin, a co-investigator on CTN-0073-Ot, gave an overview of his team’s work on wearable sensing and computing technologies, including their potential benefits and challenges.

Mobile sensor technologies have a number of potential benefits. For example, wireless wearable biosensors paired with powerful mobile phone and cloud computing infrastructures may provide new insights into individuals’ health, symptoms, and functioning. And they may be used to help facilitate prevention of chronic diseases and provide just-in-time adaptive interventions to promote healthy behavior patterns.

Still, there are a number of challenges when implementing mobile sensing systems, such as designing a wearable sensor that enables precise measurement of large volume physiological data, while minimizing the burden on participants. Advances in computational algorithms are necessary to transform sensor data into clinically meaningful biomarkers.

Can physiological measures enable new insights into our behavior and act as biomarkers for certain chronic diseases? Is it possible for wireless wearable wristbands to reliably detect cocaine use? To find out answers to these questions and more, Dr. Ertin’s presentation can be viewed on the Northeast Node’s website.

In addition to his role on the CTN-0073-Ot study, Dr. Ertin is an Associate Professor with the Department of Electrical and Computer engineering and a principal investigator with the Dorothy M. Davis Heart and Lung Research Institute at The Ohio State University. He currently serves as the Sensor Technology Lead for the NIH Center of Excellence in Mobile Sensor Data-to-Knowledge (MD2K) that develops big data solutions to quantify physical, biological, behavioral, social, and environmental factors that contribute to health and wellness in daily life.

The next presentation in the Northeast Node’s Science Series will be held on Thursday, November 16, from 12-1pm EST. Dr. Mary Brunette from the Northeast Node will present on tobacco cessation among individuals with substance use disorders. If you’d like to join the Science Series mailing list, please email Bethany McLeman.

Western States

The British Columbia Centre for Excellence in HIV/AIDS in partnership with Vancouver Coastal Health are working to improve care for primary care patients with opioid use disorder -- BOOST (Best-practices in Oral Opioid agoniSt Therapy). The initiative is a response to a dramatic increase in opioid overdose fatalities in the Vancouver area and the widespread use of fentanyl.

The collaboration is an extension of the Treatment as Prevention strategy that British Columbia applied to the HIV epidemic and reduced population levels of HIV infection. The participating primary care clinics (n = 20) are using a quality improvement structure that applies the chronic care model and seeks to increase the percent of primary care patients with opioid use disorder on an oral opioid agonist therapy (i.e, buprenorphine, methadone, and for some patients long acting morphine) from an estimated 70% to 90%. Dennis McCarty (co-PI with the Western States Node) was an invited speaker and facilitator at the September 15 BOOST launch.

See the BOOST website for more information about this new initiative: http://stophivaids.ca/oud-collaborative/

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New CTN Protocol: Initiating Extended-Release Buprenorphine for Opioid Use Disorder in Rural Emergency Department Settings (CTN-0079)

CTN0079 iconLead by Ryan McCormack, MD and John Rotrosen, MD from the Greater New York Node, CTN-0079 will involve two components:

1) An open-label non-randomized trial comparing a cohort of patients willing to accept ED-initiated BUP and referral for ongoing MAT to a cohort of patients not willing to accept ED-initiated BUP who will be offered treatment-as-usual (TAU) and who agree to be followed;

2) A qualitative, descriptive study including formative evaluation using mixed methods to learn what is needed to implement ED-initiated BUP and to describe implementation across both study phases.

Read more about CTN-0079 here. . .

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Upcoming Events

October 2, 12-1:30pm ET (webinar): CSAT/CTN Webinar: Digital Therapeutics for Substance Use Disorders: The State of the Science and Opportunities for Implementation in Substance Use Disorder Care.

October 3, 1:30-3pm ET (livestream): The Opioid Crisis: Harvard Medical School Responds with Education.

November 27-29 (in-person): First National Conference on Addiction Psychiatry (NCAP), New Delhi. Theme: Emerging Trends in Addiction Psychiatry. Abstracts due October 31.

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New from the ATTC

The September 2017 issue of the ATTC Messenger focuses on the theme of Recovery-Oriented Systems of Care (ROSCs). The featured article, by Michael Flaherty, PhD, "Recovery Oriented Systems of Care: It's All About Recovery!", looks at the history of our country's approach to substance use and addiction, and the seismic transformation to treatment that took place when that approach brought Americans who had already found recovery back into the process. Read it here. . .

Also new this month: the 2017 Alcohol Awareness Month (April) Faith Community Bulletin Insert, a pamphlet about risks of and treatment for alcohol use disorders designed for churches, temples, mosques, and other religious institutions.

New posts from the ATTC/NIATx Service Improvement Blog:


Also of Interest

NIH FOA: Collaborative Minority Health & Health Disparities Research with Tribal Epidemiology Centers
The purpose of this initiative is to support collaborative research between Tribal Epidemiology Centers and extramural investigators on topics related to minority health and health disparities in American Indian/Alaska Native (AIAN) populations. An R01 and an R21 are both available. Read more here. . .

New Training Opportunity with AHRQ/PCORI
The Agency for Healthcare Research and Quality (AHRQ), in partnership with the Patient-Centered Outcomes Research Institute (PCORI), invites applications that propose innovative career development programs designed to train clinician and research scientists to conduct PCOR research. Read about the program objectives and find out how to apply 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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