Clinical Trials CTN Bulletin

October 7, 2015 Network Volume 15-10 # 323

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Keep your CTN colleagues up to date! CTN News ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ In the CTN Bulletin, you will find news from the CTN study teams and Nodes, announcements of opportunities Trial Progress: for involvement and training, and a lot more!

Your Node and study news is the keystone of the CTN Trial enrollment numbers reflect Bulletin. Keep your CTN colleagues up to date on your study results as of the October 7, 2015 Node’s and study’s activities and accomplishments. If your Trial Progress Report Node would like to receive reminders of the due dates for submission of articles and other items of interest, please Open Studies request a reminder by sending an email to:

• CTN 0050 – Long Term Follow-up to the CTN 0027 [email protected]. The due dates for the next CTN (START) Study. Enrolled 875 (Original N=1,267 Bulletin can also be found on the last page of each issue. START Study participants). • CTN 0051 – X-BOT (Extended Release Naltrexone vs. Is there someone in your Node who would like a copy of Buprenorphine for Opioid Treatment). Enrolled 412 the CTN Bulletin sent directly to them? Please send the (N=550). individual’s name and email address to the email above to • CTN 0053 – ACCENT (Achieving Cannabis Cessation: add them to the mailing list for the next issue. The CTN is Evaluating N-Acetylcysteine). Enrolled 302 (N=300) – looking forward to reading about you! data lock occurred October 5. • CTN 0055 – CHOICES (Comparing Treatments for ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ HIV-Positive Opioid Users in an Integrated Care CTN Node & Coordinating Center News Effectiveness Study). Enrolled 51 (N=50) – follow up period completed, data lock October 7 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

• CTN 0056-Ot – Testing and Linkage to HIV Care in China. Enrolled 478 (N= 360) – in extended follow up Western States Node

period. Medication Assisted Treatment • CTN 0057-Ot – SBIRT-PC (Screening, Brief Intervention, and Referral to Treatment in Primary Care). On Friday, September 17th, Michael Botticelli, Director of Enrolled 107 (N=120). the Office of National Drug Control Policy, hosted a White Total Enrolled All Studies: 19,548 House symposium entitled “Medicine Responds to Addiction.” It was attended by leaders in graduate medical training, federal agencies, supporting institutions, and

representatives of current and emerging addiction medicine fellowship training programs. Speakers included leaders from NIDA (Wilson Compton, MD, MPE), NIAAA (George Koob, PhD), CDC (Tom Frieden, MD, MPH), and the Surgeon General (Vivek Murthy, MD, MBA).

One of the main purposes of the symposium was to highlight the need for developing a trained and certified physician workforce to effectively address the prevention and treatment of substance use disorders across the country. Medication-assisted treatment was featured as an example of how the findings of important research, such as that conducted by the NIDA CTN, need to be translated and disseminated into wider practice. To develop the

CTN is a program of the National Institute on Drug Abuse, part of the National Institutes of Health within the Department of Health and Human Services. workforce and leadership to care for the many persons Trials Network” at the quarterly meeting of the state’s affected by addiction, the American Board of Addiction AOD Treatment Director’s group. During her Medicine (ABAM) Foundation has created addiction presentation she discussed the background of the medicine fellowship programs at 36 medical schools and CTN, accomplishments, and goals for the future. The teaching hospitals across North America with the larger meeting was attended by representatives from the goal of establishing a total of 125 ACGME accredited South Carolina single state authority and treatment fellowship programs by 2025. Among these are established programs at OHSU and UBC and a new program at supervisors from each of the county’s community UCSF—academic institutions each involved with the treatment programs including five CTPs that have Western States node, specifically CTN 0055. participated in CTN trials.

Use the link below to access the official press release: CTN 0057-Ot Publishes! https://www.whitehouse.gov/the-press- “Substance use and mental diagnoses among adults with office/2015/09/18/white-house-drug-policy-office-hosts- and without type 2 diabetes: Results from electronic health %E2%80%9Cmedicine-responds-addiction%E2%80%9D th records data” Wu, L et al. is in press as of September 12 New OHSU Addiction Medicine Fellowship 2015. You will find the article in Drug and Alcohol Dependence at this link: Addiction specialists can play a critical role in addressing http://www.sciencedirect.com/science/article/pii/S0376871 the treatment gap for substance use disorders, improving 615016294 patient care, and increasing access to effective medication- assisted treatments. In response to the need for an Mid-Atlantic Node expanded addiction workforce, the Division of General Internal Medicine at Oregon Health & Science University The Mid-Atlantic Node in collaboration with the Region 3 applied for a new Addiction Medicine fellowship. Interim (Central East) ATTC continues to offer a series of accreditation was granted by the American Board of Motivational Interviewing Lunch & Learn Webinars Addiction Medicine Foundation, and the new program on selected Wednesdays from 1:00 - 1:30 p.m. (EST). accepted its first fellow in July 2015. Todd Korthuis, MD, These include lively discussions of each week’s topic MPH, the LI of the CTN 0055 study, led the development hosted by Christine Higgins, MA, MIA-Step Trainer, and of the Fellowship and directs the initiative. The fellowship Dissemination Specialist at the Mid-Atlantic Node. The partners with Hazelden Betty Ford Foundation outpatient three upcoming topics will be of special interest to the and residential facilities, Central City Concern, and CODA, CTN community. The following link will take you to the Inc. to provide diverse community-based and academic home page of the Central East ATTC to register: Click here training opportunities. Because addiction is a pervasive to Register disease that effects a broad range of specialties, the new “The Readiness Ruler” fellowship will be multidisciplinary, recruiting eligible applicants from Internal Medicine, Family Medicine, Date & Time: October 14, 2015, 1:00 - 1:30 PM ET Emergency Medicine, Obstetrics/Gynecology, and Pediatrics. Fellows will be supervised by faculty trained in Therese Killeen, PhD from the Southern Consortium Node internal medicine, family medicine, psychiatry and will join Christine Higgins, MA to discuss the Readiness addiction psychiatry, as well as addiction medicine. The Ruler or Importance Ruler—a tool used in MI to assess fellowship will prepare its graduates to pursue careers in readiness. Both presenters will explore the nuances to this integrating addiction medicine into general health care useful tool. settings, addiction specialty care settings, academic medicine, or research. To learn more, or to apply for the “MI Sandwich/MIA-Step” program, please contact Dr. Todd Korthuis Date & Time: October 21, 2015 1:00 p.m. - 1:30 PM ET ([email protected]) or Dr. Melissa Weimer ([email protected]). Paul Warren, PhD of the Northeast ATTC (New York and the Caribbean) will discuss why the MIA-Step Blending Southern Consortium Node Product is such a valuable tool for clinical supervision and where it fits into MI Training. Christine Higgins, MA will Talking about the CTN discuss how a CTN protocol designed to improve patient engagement was a springboard for developing MIA-Step On August 11, 2015, Louise Haynes, MS presented and explain the MI Sandwich. “Fifteen Years and Counting: The NIDA Clinical

2

“MI SIMmersion”

Date & Time: November 4, 2015, 1:00 - 1:30 PM ET

Geetha Subramaniam, MD, DFAPA, Deputy Director of the CCTN, will explain how the on-line MI SIMmersion interactive web-based program developed by the NIDA A forum for discussing the science of dissemination Blending Initiative can be used by medical personnel and and implementation, this conference aims to grow other health practitioners who want to learn how to use the research base by bridging the gap between Motivational Interviewing with their patients. evidence, practice, and policy in health and medicine. CCC & DSC The theme, ‘Optimizing Personal and Population 2015 CTN WEBINAR SERIES: October Webcast Health,’ reflects the twin challenges to the field in this new era of health and health care. First, the “Concepts of CBT and Strengths-Based Approaches to Addiction and Mental Health concept of precision (or personalized) medicine Research and Treatment” encourages us to think about how to provide the best possible health information and services to Date & Time: October 14, 2015, 1:00 PM ET meet individual needs, preferences, and local environments. Second, new expectations and Description: opportunities exist to make large-scale gains in

In the CTN, investigators and research staff engage in the health at a population level. As a result, the conduct of studies and treatment for patients dealing with integration of evidence-based practices and service substance use and mental health disorders. There are a delivery has the capacity to improve healthcare number of interventions and approaches used for relapse delivery and population health. This imperative prevention and recovery, including coaching and exists for stakeholders in the U.S. and globally. counseling for lifestyle and behavioral modifications. This REGISTRATION one-hour webinar will discuss Cognitive-Behavioral Treatment and strengths-based approaches as interventions to prevent relapse and sustain recovery in treatment and Registration is now open. research settings. TECHNICAL ASSISTANCE WORKSHOP

Objectives: The technical assistance workshop will be held on Wednesday, December 16 at the Marriott Marquis • Provide a brief introduction and overview of CBT as it is Washington, DC. utilized in substance use and mental health disorders. • Introduce the Dysfunctional Thought Record and discuss how this can be utilized with substance use and mental health disorders. NIDA News • Describe the use of structure in CBT. • Outline a CBT session. NIDA Director at ASAM Press Conference about • To Register: Copy and paste the following link into your Practice Guidelines web browser and once connected follow the registration On September 24, NIDA Director Nora Volkow, MD instructions: participated in a press conference at the National Press https://cc.readytalk.com/r/8d9sflb9bknw&eom Club in Washington, DC, about the American Society of Upon completing your registration, you will receive an Addiction Medicine’s National Practice Guidelines. The email confirmation that will include the information Guideline is a tool for clinicians to provide a more needed to join the event. If you have questions or you do uniform, higher quality of care to patients with addictions not receive your registration confirmation, please notify the involving opioid use. Other participants in the press CCC at [email protected]. conference include representatives from ONDCP and CDC.

3

NIDA’s Deputy Director Rappelled 12 Stories for (NIDA). “Adolescents have access to high potency Shatterproof Challenge marijuana and greater varieties of nicotine delivery devices than previous generations. We want to know how that and On September 25, NIDA Deputy Director Wilson other trends affect the trajectory of the developing brain.” Compton, MD, MPH rappelled down 12 stories on “The ABCD Study is an important opportunity to closely Lafayette Tower in Washington DC, as part of a national examine, in humans, the hypothesized link between movement to raise awareness about drug and alcohol adolescent alcohol abuse and long-term harmful effects on addiction. Preceding the rappelling, Dr. Compton brain development and function,” said George Koob, PhD, participated in a press conference along with Shatterproof director of NIH’s National Institute on Alcohol Abuse and Founder and CEO Gary Mendell and several Congressmen. Alcoholism (NIAAA). “Recent human studies have Shatterproof, a national organization committed to revealed an acceleration in the typical decline in volume of protecting our children from addiction to alcohol or other neocortical areas and smaller increases in white matter drugs and ending the stigma and suffering of those affected volume in adolescents who transitioned to heavy drinking by this disease, is hosting more than 20 events in 2015 in compared to those who did not using magnetic resonance cities across the United States. See Dr. Compton pictured imaging.” below (circled in green) as he descends! The ABCD Study will seek to address many questions related to substance use and development that will help inform prevention and treatment research priorities, public health strategies, and policy decisions.

The requests for applications and other information about the ABCD Study, including protection of patient confidentiality and parental consent, can be found at http://addictionresearch.nih.gov/adolescent-brain- cognitive-development-study. The ABCD Study was initiated by the Collaborative Research on Addiction at NIH (CRAN). See the NIDA website at http://www.drugabuse.gov/news-events/news- releases/2015/09/nih-launches-landmark-study-substance- From the NIDA Website (see the full story at use-adolescent-brain-development for more information www.drugabuse.gov) and a complete listing of participating institutes.

NIH launches landmark study on substance use and Note: NIDA has a special section on its website related to adolescent brain development the current state of the science on substances and brain health. The National Institutes of Health awarded 13 grants to research institutions around the country as part of a NIDA Deputy Director at Appalachian Opioid Abuse landmark study about the effects of adolescent substance Summit use on the developing brain. The Adolescent Brain On September 23-24, NIDA Deputy Director Wilson Cognitive Development (ABCD) Study will follow Compton, MD, MPH gave a plenary address, “Addiction approximately 10,000 children beginning at ages 9 to10, and the Brain,” at the Appalachian Opioid Abuse Summit: before they initiate drug use, through the period of highest Understanding the Impact of Opioids on Appalachia. The risk for substance use and other mental health disorders. goal of the summit was to mobilize efforts across systems Scientists will track exposure to substances (including and state borders to address the opioid epidemic in nicotine, alcohol, and marijuana), academic achievement, Appalachia. Dr. Compton also moderated a session titled cognitive skills, mental health, and brain structure and “Emerging Health Crises” which discussed best practices function using advanced research methods. and information sharing among states to handle potential “With advances in neuroimaging and other investigative outbreak crises that arise from intravenous drug use. In tools, we will be able to look in greater detail at the impact addition, Dr. Compton served on a panel of federal of substance use on young people,” said Nora D. Volkow, representatives to explore how agencies strategize for MD, director of NIH’s National Institute on Drug Abuse collaboration and sustainability of efforts.

4

Funding Opportunities * Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Development of Minimally- Notices Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01) (NOT- Review of Grants Information for Fiscal Year 2015 DA-15-076) National Institute on Drug Abuse (NOT-OD-15-160) National Institutes of Health

Requests for Applications Notice of Change in Applicants’ Eligibility for RFA-AA- 16-004 “Integrative Neuroscience Initiative on Alcoholism Phased Innovation Award for Mechanistic Studies to (INIA) Consortia (Collaborative U01)” (NOT-AA-15-017) Optimize Mind and Body Interventions in NCCIH High National Institute on Alcohol Abuse and Alcoholism Priority Research Topics (R61/R33) (RFA-AT-16-005) National Center for Complementary and Integrative Health * Notice of Intent to Publish a Funding Opportunity Application Receipt Date(s): January 15, 2016 Announcement for Clinical Development of Minimally- Invasive Bioassays to Support Outpatient Clinical Trials of * Adolescent Medicine Trials Network for HIV/AIDS Therapeutics for Substance Use Disorders (R01) Interventions (ATN) Research Program Grants (U19) (NOT-DA-15-076) National Institute on Drug Abuse (RFA-HD-16-035) Eunice Kennedy Shriver National Institute of Child Health Civil Rights Protections in NIH-Supported Research, and Human Development and Other Institutes Programs, Conferences and Other Activities Application Receipt Date(s): January 19, 2016 (NOT-OD-15-152) National Institutes of Health * Adolescent Medicine Trials Network for HIV/AIDS Notice of Participation of NIDCR in RFA-OD-15-005 Interventions (ATN) Coordinating Center (CC) (U24) “Chemistry, Toxicology, and Addiction Research on (RFA-HD-16-040) Waterpipe Tobacco (R01)” (NOT-DE-15-002) Eunice Kennedy Shriver National Institute of Child Health National Institute of Dental and Craniofacial Research and Human Development and Other Institutes AHRQ Implements eRA Commons Financial Conflict of Application Receipt Date(s): January 19, 2016 Interest Module for Grantee Reporting under FCOI * Adolescent Medicine Trials Network for HIV/AIDS Regulations (NOT-HS-15-016) Interventions (ATN) Research Program Grants (U19) Agency for Healthcare Research and Quality (RFA-HD-16-035) Notice Announcing FAQ Page and Pre-Application Eunice Kennedy Shriver National Institute of Child Health Webinar for RFA-OD-15-005 “Chemistry, Toxicology, and Human Development other Institutes and Addiction Research on Waterpipe Tobacco (R01)” Application Receipt Date(s): January 19, 2016 (NOT-OD-15-150) National Institutes of Health * Adolescent Medicine Trials Network for HIV/AIDS Notice Announcing FAQ Page and Pre-Application Interventions (ATN) Coordinating Center (CC) (U24) Webinar for RFA-OD-15-006 “Abuse Liability Associated (RFA-HD-16-040) with Reduced Nicotine Content Tobacco Products (R01)” Eunice Kennedy Shriver National Institute of Child Health (NOT-OD-15-151) Office of the Director, NIH and Human Development & other institutes Application Receipt Date(s): January 19, 2016 Notice of Technical Assistance Webinar for RFA-MD-15- 012 “Behavioral Interventions to Prevent HIV in Diverse Integrative Neuroscience Initiative on Alcoholism (INIA) Adolescent Men Who Have Sex with Men (U01)” (NOT- Consortia 1) Collaborative U01 (RFA-AA-16-004) 2) MD-15-019) Research Resource Core U24 (RFA-AA-16-005) 3) National Institute on Minority Health and Health Administrative Research Core U24 (RFA-AA-16-006) Disparities National Institute on Alcohol Abuse and Alcoholism Application Receipt Date(s): March 10, 2016 Webinars for Applicants and Grant Administrators: What You Need to Know About NIH Application Submission * BRAIN Initiative: Foundations of Non-Invasive and Review (NOT-OD-15-154) Functional Human Brain Imaging and Recording - National Institutes of Health Bridging Scales and Modalities (R01) (RFA-MH-16-750) National Institute of Mental Health and Other Institutes Review of Grants Information for Fiscal Year 2015 Application Receipt Date(s): January 06, 2016 (NOT-OD-15-160) National Institutes of Health

5

* BRAIN Initiative: Next-Generation Invasive Devices for * SBIR Technology Transfer (R43/R44) (PA-15-354) Recording and Modulation in the Human Central Nervous National Institute of Neurological Disorders and Stroke & System (UG3/UH3) (RFA-NS-16-009) other Institutes National Institute of Neurological Disorders and Stroke & Application Receipt/Submission Date(s): Multiple dates, other Institutes see announcement. Application Receipt Date(s): April 26, 2016 * denotes announcements supported by NIDA * BRAIN Initiative: Clinical Studies to Advance Next- Generation Invasive Devices for ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Recording and Modulation in the Human Central Nervous Reminders and Announcements System (UH3) (RFA-NS-16-010) ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ National Institute of Neurological Disorders and Stroke & other Institutes Columbus Day Office Closures? Yes and No… Application Receipt Date(s): April 26, 2016 The CCTN offices will be closed on Program Announcements Columbus Day, Monday, October 12, 2015. * Research on the Mechanisms and/or Behavioral The DSC and CCC offices will be Outcomes of Multisensory Processing (R01) open on Columbus Day. (PA-15-347) National Institute on Aging & other Institutes Bulletin Reminder: Application Receipt/Submission Date(s): Multiple dates, see announcement. The due date for items for the next CTN Bulletin is Monday, October 26, 2015, * Administrative Supplements for Research on Sexual and Close of Business. Gender Minority (SGM) Populations (Admin Supp) (PA-15-329) National Institutes of Health & multiple institutes Application Receipt/Submission Date(s): Multiple dates, see announcement.

* BRAIN Initiative: Pre-Applications for Industry Updates for this Bulletin Partnerships to Provide Early Access to Devices for should be sent to Stimulation and Recording in the Human Central Nervous Michele Straus at [email protected] System (X02) (PAR-15-345) National Institute of Neurological Disorders and Stroke & other Institutes Application Receipt/Submission Date(s): November 18, 2015

* AIDS-Science Track Award for Research Transition Connect to NIDA through: (R03) (PA-15-290) National Institute on Drug Abuse Application Receipt/Submission Date(s): Multiple dates, see announcement

6