Protocol Updates
CTN-0074
CTN-0074, Primary Care Opioid Use Disorders (PROUD) Treatment Trial, added 100 new patients in the past 6 months! Since introducing the augmented intervention with nurse care manager (NCM) support meetings, we have increased the total number of patients ever treated from 149 patients (as of July 1, 2019) to 269 patients (as of December 30, 2019).
The CCTN approved funding to extend the intervention another year. This funding helps ensure the NCMs will not accept other positions before the end of the trial, but also allows the trial to evaluate whether a longer time period of start up support for the NCMs impacts the success of the Massachusetts Model.
The PROUD Economics Ancillary Study (aka “Econ Study”) was funded by the CTN in early 2019 and is being led by Sean Murphy and his team at Weill Cornell Medicine. Once the IRB approval and data transfer agreement are in place, completely de-identified data from the main trial will be securely transferred to Cornell to complete the Econ Study analyses.
Published Phase 1 Manuscript: Lapham GT, et al. Prevalence and Treatment of Opioid Use Disorder Among Primary Care Patients in Six Health Systems. Drug Alcohol Depend 2019;207:107732.
Read more. . .
CTN-0099
This study, Emergency Department-Initiated Buprenorphine and Validation Network Trial (ED-Innovation), will evaluate implementation of emergency department (ED)-initiated BUP in 30 diverse RCT (randomized controlled trial) sites; compare extended release (XR)-BUP with sublingual (SL) BUP in 2,000 ED patients with untreated OUD; assess changes in opioid withdrawal signs and symptoms in a subset of patients with a COWS score less than 8 who receive ED-initiated XR-BUP; and develop and validate electronic health record phenotypes of opioid-related illnesses to characterize ED visits and better identify patients eligible for study inclusion.
The RCT sites were selected in July 2019. FDA IND approval was received October 31, 2019. The protocol received IRB approval on January 10, 2020. The Braeburn/NIDA IIT (medication donation) agreement is still pending. Ancillary study site endorsement and opening for enrollment is targeted to occur in March 2020. Implementation Facilitation at RCT sites is expected to begin March 1, 2020. Centralized training for sites participating in the RCT is scheduled for March 11, 2020. The Lead Investigators are Gail D’Onofrio, M.D. & David Fiellin, M.D.
CTN-0100
This 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).
In the Retention Phase (N=1800), the study aim is to test, among adult patients seeking treatment for opioid use disorder (OUD), strategies (i.e., high BUP dose, extended-release BUP formulation, and a smartphone-based behavioral intervention) to improve retention in treatment on BUP and XR-NTX.
In the Discontinuation Phase (N=up to 1000), the study aim is to test strategies to improve outcomes among patients who have achieved stable remission on MOUD and want to discontinue MOUD; these include transition from sublingual-BUP to extended-release BUP and a smartphone-based behavioral intervention.
An additional aim of the Discontinuation Phase is to develop predictive models of successful discontinuation of MOUD among patients who discontinue medication, based on patient characteristics, including duration of MOUD prior to discontinuation. The RDD protocol was approved for implementation in September, 2019.
Read more. . . |
CTN-0101
As one of the new CTN HEAL studies, CTN-0101, the Subthreshold Opioid Use Disorder Prevention (STOP) Trial, is an innovative study of early intervention for adults with risky opioid use. STOP is a primary care-based collaborative care intervention to reduce opioid use and overdose risk, and prevent progression to opioid use disorder, in adult patients who have risky use of illicit or prescription opioids. This 4-year study will test the effectiveness of STOP versus enhanced usual care.
A total of nine primary care clinics will participate from the following five study sites: Dartmouth-Hitchcock (Northeast Node), Chase Brexton Health Care (Mid-Atlantic Node), UPMC Pinnacle Medical Group (Appalachian Node), University of Utah (Greater Intermountain Node), and The Ohio State University (Ohio Valley Node). A 10-week pilot study is set to launch in February at the Dartmouth-Hitchcock site. Recruitment for the main study launches in September 2020.
The Lead Investigator is Jennifer McNeely, MD, MS from the Greater NY Node, and Co-Lead Investigator is Jane Liebschutz, MD, MPH from the Appalachian Node. For more information, contact the Project Manager, Rebecca Shore rebecca.shore@nyulangone.org.
Node News
New England Consortium
 Ayana Jordan, MD, PhD, Assistant Professor of Psychiatry, has been appointed Associate Program Director for the Yale Department of Psychiatry Residency Program.
Ayana directs the Global Mental Health Program at Yale and the social justice and health equity curriculum within the residency. She is also Medical Director of the REACH scholars program, an educational program which aims to train a national cohort of physicians and allied health professionals committed to improving health equity in addiction services. Her research focuses on community partnership with faith settings to improve addiction treatment and outcomes for minoritized populations. One such program, IMANI Breakthrough, partners with five Black and four Latinx churches to improve addiction outcomes throughout the state of Connecticut.
Ayana is very active in the CTN Minority Interest Group. Congratulations in your new position!
Western States Node
The CTN Western States Node and the Northwest ATTC are co-sponsoring a new webinar this February.
 Methamphetamine Use Disorder: Getting Up to Speed on Trends and Treatments
February 25, 2020
11am-12:30pm (PT)
Presented by Robrina Walker, PhD,
University of Texas Southwestern Medical Center (TX Node)
In this webinar, Dr. Walker will describe trends in the use of methamphetamine, describe evidence-based treatments for methamphetamine use disorder, and summarize current research investigating new treatments for methamphetamine use disorder.
1.5 NAADAC CEU will be available for those who attend this webinar live!
Download/share the flyer | Register here! |
Apply to be an NIH DATA Scholar
New in the CTN Dissemination Library
American PsychoPathological Association Conference: March 5-7, 2020. New York City, NY. Theme: Substance Use, Substance Use Disorders: Changing Concepts, Changing Patterns. Registration is open! 
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