CTN Bulletin Clinical Trials May 22, 2013 Network Volume 13 - 08

Trial Progress – Over 15,000! Greater New York Node News The Greater New York Node held its semiannual Node Trial enrollment numbers reflect study and Stakeholders Meeting May 3rd information as of May 21, 2013. at NYU School of Medicine. Participants included representatives from all of their Open Studies Community Treatment Providers, • CTN 0048 – CURB (Cocaine Use Reduction with , Columbia University, Cornell Buprenorphine). Enrolled 302 (N=300). Enrollment University and The Rockefeller University, as well as completed – Completed follow-up, data lock next. leaders from the New York City Department of Health • CTN 0049 – Project HOPE (Hospital Visit as and Mental Hygiene, the New York City Health and Opportunity for Prevention and Engagement for Hospitals Corporation, the New York State Office of HIV-Infected Drug Users). Enrolled 475 (N=800). Alcoholism and Substance Abuse Services and the • CTN 0050 – Long Term Follow-up to the CTN Northeast and Caribbean Basin ATTC. Drs. Betty Tai 0027 (START) Study. Enrolled 813 (N=1,267). and Udi Ghitza joined from NIDA CCTN. Foci of the • CTN 0052 – BRAC (Buspirone for Relapse- meeting included: (1) integrating and coordinating Prevention in Adults with Cocaine Dependence). screening and interventions across mainstream Enrolled 62 (N=60). Enrollment completed – in and specialty settings; (2) the use of technology to follow up phase. facilitate this; (3) scaling up and implementation research; and (4) an update on how addictions research Total Enrolled All Studies: 15,905 and practice were sustained in the wake of Hurricane Sandy. Betty and Udi talked about leveraging the EHR CTN 0047 Locked Database! (Electronic Health Record) to facilitate SBIRT in CTN 0047 – SMART-ED (Screening, Motivational mainstream and addictions settings; Jennifer McNeely Assessment, Referral, and Treatment in Emergency spoke on automated ACASI-administered screening Departments) started enrolling instruments for mainstream settings; Ned Nunes participants at 6 hospital emergency presented key findings from CTN-0044 on web-based departments in October 2010. The study interventions; and Stan Sacks and Mike Chaple talked reached its target enrollment of 1,285 patients 16 months about training and implementation on a State-wide level. later in February 2012. The one-year follow up Ellie Grossman, Babak Tofighi and Helena Hansen assessments were completed in February 2013. The discussed lessons learned from Hurricane Sandy, with a database was locked on May 16, 2013. The Lead particular focus on sustaining methadone and Investigator team is working on a final report to NIDA buprenorphine services from the perspectives of both and the DSMB for September 2013. Congratulations to patients and providers. all! Federal Offices Closed Delaware Valley Node Update The CCTN office and NIDA will be Dr. George Woody, Node PI, gave a presentation at the closed on Monday, May 27, 2013, for the APA annual conference, May 18-22, in San Francisco, Memorial Day holiday observance California, entitled: “Co-morbidity and Practical Issues of Treatment in the NIDA CCC and DSC Closed Clinical Trials Network.” This presentation The NIDA CCC (Clinical Coordinating Center) and DSC was co-authored by Dr. Tom McLellan and (Data and Statistics Center) offices at EMMES will be started with an overview of what we have learned about closed Monday, May 27, 2013 in observance of the psychiatric co-morbidities and how we learned it, then Memorial Day Holiday. The DSC 2 Help Desk will not moved on to the importance of substance use treatment be available that day, but DSC staff will respond to your for improving outcomes of other medical disorders, and requests when the office reopens the next business day. ended with a discussion of how the Affordable Health

Care Act and the new DSM-5 criteria might work CTN is a program of the National Institute on Drug Abuse, together to facilitate the integration of treatment for part of the National Institutes of Health within the substance use disorders with general healthcare. Department of Health and Human Services.

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Pacific Node Update - Taipei Conference Ph.D., Director of ISAP’s Center for Advancing The biennial Conference Series to Longitudinal Drug Abuse Research (CALDAR), David Promote Global Health is sponsored by Geffen School of Medicine at UCLA. NIDA, in collaboration with organizations in Asia and around the world. The first meeting, which was held April 17–19, 2013, in Taipei, Taiwan, was organized by UCLA in partnership with the Taiwan National Health Research Institutes (NHRI) and the Taiwan Food and Drug Administration (TFDA); 365 participants from 17 countries attended the meeting. This event was co-hosted by CTN 0050 Principal Investigator Yih-Ing Hser, Ph.D., Director of ISAP’s Center for Advancing Longitudinal Drug Abuse Research (CALDAR), David Geffen School of Medicine at UCLA.

The theme was prevention and treatment of substance

abuse and HIV, focusing on Asia and the Pacific Islands (API). The conference sessions covered the current status Special guests at the April 2013 Taipei meeting of the Conference of drug abuse and HIV in Asian countries as reported by Series to Promote Global Health were (from left) (1) Yun Wang, M.D., their representatives, featured strategies for meeting PhD., Director, Center for Neuropsychiatric Research, National Health Research Institutes, Taiwan; (2) Wen-Ing Tsay, Director, Division of challenges posed by these problems, and promoted Controlled Drugs, Food and Drug Administration, Department of international collaborative work on the prevention and Health, Executive Yuan, Taiwan; (3) Barry J. Hoffer, M.D., Ph.D., treatment of substance use and HIV in order to promote Case Western Reserve University School of Medicine, USA; (4) Gene- health in API and other populations. Jack Wang, M.D., , USA; (5) Nora D. Volkow, M.D,. Director, National Institute on Drug Abuse (NIDA), National

Institutes of Health (NIH), USA; (6) Wen-Ta Chiu, M.D., Ph.D. Drug use persists as a major problem that severely Minister, Department of Health, Executive Yuan, Taiwan; (7) Gilberto impacts the health of individuals and populations, locally Gerra, M.D., Chief, Drug Prevention and Health Branch, United and globally. The international Conference Series to Nations Office On Drugs and Crime (UNODC), Vienna; (8) Ing-Kang Promote Global Health is designed to share research Ho, Ph.D., China Medical University Hospital, Taiwan; (9) Hsing-Jien Kung, Ph.D., President, National Health Research Institutes, Taiwan; findings on substance abuse treatment and HIV (10) Jaw-Jou Kang, Ph.D., Director, Taiwan Food and Drug prevention, stimulate international collaborations, Administration, Department of Health, Executive Yuan, Taiwan; and particularly between the United States and API countries, (11) Yih-Ing Hser, Ph.D., University of California, Los Angeles, USA. and inform cultural aspects of treatment and prevention Future meetings will rotate among different locales in of substance abuse and HIV. These and upcoming activities are part of efforts to extend NIDA’s mission of Asia, the Pacific Islands, and the United States. Planning promulgating research-based interventions to improve for the 2015 conference is underway. Conference presentations and upcoming information will be posted at health services and promote health globally. www.caldar.org. Keynotes were delivered by Nora Volkow, M.D., NIDA Director, and Gilberto Gerra, M.D., Chief of the Drug New Funding Opportunities Prevention and Health Branch for the United Nations The following announcements may be Office on Drugs and Crime (UNODC). Local officials of interest to those in the CTN: (Wen-Ta Chiu, M.D., Ph.D., Minister, Department of • Health, Executive Yuan, Taiwan; Jaw-Jou Kang, Ph.D., Integration and Analysis of Diverse HIV-Associated Director, Taiwan Food and Drug Administration, Data (R03) (RFA-MH-14-200)

Department of Health, Executive Yuan, Taiwan; Hsing- • NIDA Research Center of Excellence Grant Jien Kung, Ph.D., President, NHRI, Taiwan) opened the Program (P50) (PAR-13-222) conference with a welcome to the participants, and NIDA officials (Wilson Compton, M.D., M.P.E., Jacques • Notice to Clarify Number of Applications Allowed Normand, Ph.D., Betty Tai, Ph.D.) and many eminent per Institution for RFA-DA-14-004 Medications researchers presented cutting-edge research findings and Development Centers of Excellence Cooperative led discussions. Speakers from UCLA Integrated Program (U54) (NOT-DA-13-027) Substance Abuse Programs (ISAP) included Richard A. Rawson, Ph.D., and Walter Ling, M.D. This event was • Substance Use Disorders and Molecular Regulation co-hosted by Yun Wang, Ph.D., Director, Center for of Brain Energy Utilization (R01)(RFA-DA-14-005) Neuropsychiatric Research of NHRI, and Yih-Ing Hser, 2

New England Consortium Node News Day Two of the conference was the North Dakota Roger D. Weiss, MD , Shelly F. Counselor Association’s Spring Conference, Greenfield, MD, MPH, Hilary S. Connery, at which Drs. Somoza and Winstanley provided MD, PhD, Kevin Hill, MD, MHS, and R. presentations on novel medications to treat addiction, Kathryn McHugh, PhD from the New methadone, overdose prevention, barriers to MAT England Consortium Node were all adoption and using social media. Approximately 76 presenters at the McLean Hospital/Harvard Medical people attended the first day and 68 people attended the School “Addictions in 2013” Conference on May 10-11, second day. 2013, at the Renaissance Boston Waterfront Hotel in Boston, Massachusetts. Presentations covered topics such as the psychopharmacologic treatment of opioid dependence, mood disorders and substance abuse, gender differences in addiction and its treatment, treatment of cannabis dependence, cognitive behavioral therapy and motivational interviewing. Many of the presentations included findings from NIDA CTN studies. A. Thomas McLellan, PhD from the Treatment Research Institute delivered the keynote address reviewing healthcare reform and its impact on the care and delivery of substance use disorders.

New England Consortium Node members from SSTAR Kurt Snyder (L-Heartview) and Eugene Somoza (R-Ohio Valley Node) and AdCare treatment programs delivered presentations at the “Innovations in Addictions: Integrating Systems The timing of this conference is significant for two and Services” conference in Norwood, Massachusetts, on reasons. First, North Dakota recently passed legislation May 10, 2013. The Conference is supported by the to allow Opioid Treatment Programs. Previously, North Massachusetts Department of Public Health, Bureau of Dakota was one of only two states that did not allow Substance Abuse Services (BSAS) with additional methadone treatment, and North Dakota clinicians have support provided by the AdCare Educational Institute, very limited experience using addiction medications. Inc. Genie Bailey, MD and Nancy Paull, MS, LADCI, There are 13 physicians in the State that can prescribe delivered a presentation on Integrated Substance Abuse buprenorphine; however, local physicians report that Treatment based on the experiences at SSTAR with only approximately 5 physicians are actually prescribing providing Buprenorphine treatment in a Primary Clinic buprenorphine, and perhaps only 2-3 are accepting new within a Federally Qualified Health Center. Patrice patients. In preparation for this conference, Dr. Muchowski, ScD and Susan Hillis, LICSW, CADCII, Winstanley traveled to North Dakota in October 2012 LADCI from AdCare Hospital were among a group of and Kurt Snyder (Heartview’s CEO) facilitated meetings presenters who described the process of developing an with key stakeholders in the State, including the Attorney Electronic Health Record (EHR) system, from vendor General. This was an important step to ensure that selection, implementation planning, and staff training, to science was considered as part of the decision of whether and through the “go-live” point and including the current to enact legislation that would allow for OTPs. post-implementation reality. Secondly, this conference is important because North

Dakota is in the middle of an oil boom. While the oil Ohio Valley Node (OVN) Update boom has brought economic prosperity to residents, it Medication Assisted Treatment in North has not come without a cost – one of which is increasing Dakota The Ohio Valley Node collaborated rates of prescription opioid and heroin use. Hence, the with their Community Treatment Program demand for treatment for opioid dependence has (CTP), Heartview, to plan a two-day increased. conference on medication assisted treatment in

Jamestown, North Dakota, at the State hospital. Day One The OVN is very thankful for the partnership with of the conference was a two-track buprenorphine Heartview, as well as the American Osteopathic training. Track one was the PCSS-B Half and Half Academy of Addiction Medicine and the Central Rockies Buprenorphine Training for physicians that was Addiction Technology Transfer Center that made this sponsored by the OVN and the American Osteopathic conference possible. As a result of the OVN’s trip in Academy of Addiction Medicine. Track two was the October 2012, Heartview’s physician was able to start NIDA/SAMHSA buprenoprhine blending product prescribing Vivitrol, and we are hopeful that this training for all non-physicians that was sponsored by the conference will make a real difference in people’s path to Central Rockies Addiction Technology Transfer Center. recovery. 3

Western States Node News mid- and late-career researchers). The NIH expects all Congratulations to Elinore F. McCance- programs to foster the participation of individuals from Katz, M.D., from UCSF in the Western backgrounds underrepresented in biomedical and States Node. Dr. McCance-Katz has behavioral research, including individuals from been appointed as SAMHSA's underrepresented racial and ethnic groups, individuals (Substance Abuse and Mental Health with disabilities and persons from disadvantaged Services Administration) first chief backgrounds. Therefore all applications must include medical officer. In this capacity, she plans to recruit a diverse group of students and faculty. will provide medical-scientific expertise to SAMHSA's Some examples of topics appropriate for this major behavioral health efforts, including those announcement include the following: promoting the prevention of mental illnesses and substance use disorders, as well as the treatment and • Mobile and wireless health (mHealth) recovery of people living with these conditions. methodologies for the conduct of BSSR. • Innovations in dissemination and implementation Dr. McCance-Katz will work with leading scientists in research methodologies. the field of behavioral health to ensure that SAMHSA • Quasi-experimental designs and other designs that advances effective, state-of-the-art, evidence-based complement randomized controlled trial designs. approaches to promoting the Nation's behavioral health • “Big data” mining, pattern recognition, services. “As SAMHSA's Chief Medical Officer, Ellie integration, visualization and analysis which will greatly enhance SAMHSA's ability to bring the best encourage hypothesis testing or analysis of BSSR available medical science and clinical perspective to bear research questions. in promoting all aspects of the Nation's behavioral • Merging multiple iterations of experimental or health,” said Administrator Pamela S. Hyde, J.D. survey data that contain common data elements Congratulations! (e.g., two data sets that both contain the same measure of depression). OBSSR Funding Opportunity • Statistical matching methods to identify the same OBSSR (NIH Office of Behavioral cases in different datasets. and Social Sciences Research) • Innovations in community-engaged or community- announces that they are leading a based, participatory research. trans-NIH funding opportunity • Cost-benefit or cost-effectiveness analyses of announcement calling for short behavioral, social, policy or public health courses on innovative research methodologies in the initiatives. behavioral and social sciences and includes Big Data. • Innovative study designs, creative uses of existing

data, and novel analytical approaches for cross- RFA-OD-13-009 Short Courses on Innovative national comparisons of data relevant to health. Methodologies in the Behavioral and Social Sciences • (R25) http://grants.nih.gov/grants/guide/rfa-files/RFA- Innovative methods for the analysis of longitudinal OD-13-009.html multidimensional data (e.g., growth curves) Letter of Intent Due Date: June 3, 2013 including issues related to missing data. Application Due Date: July 3, 2013 • Innovations in short, brief interventions and referrals to treatment (SBIRT) in medical and non- The NIH Research Education (R25) grant mechanism medical settings. is designed to support the development of creative and • Methods to develop common data element innovative research education programs for the approaches for integrative behavioral development of biomedical, behavioral, and clinical interventions. researchers, or for public education and outreach on • Methods to develop translational tools for health-related research to a variety of audiences. integrative behavioral interventions. Applicants are expected to describe the learning • Algorithms for measuring the construction of objectives for the proposed short course, how the short, brief interventions and referrals to treatment proposed course will enhance existing skills and (SBIRT) measurement and/or methods to evaluate capabilities of the target participants, and how the the effectiveness of research delivery models in learning will be measured. Target participants include medical and non-medical settings. those just starting their careers (e.g., graduate/medical students, medical residents, postdoctoral scholars, See the full announcement at: early-career investigators) as well as established http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-13- investigators who are interested in learning new 009.html methods to apply them in their area of research (e.g.,

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Pacific Northwest Node News For your calendar, we have the following training Congratulations to Co-PI, Dr. John Roll, on his webinars scheduled for the rest of the year: new appointment. Dr. Roll will assume a new role as Washington State University Spokane's Topic/Date/Presenters Webinar Description senior vice chancellor for academic affairs and research Developing Medication This one hour presentation effective July 1. Assisted Treatment (MAT) will review some of the Protocols, July 17, 2013 lessons learned from prior Clinical Coordinating Center (CCC) at EMMES medication assisted treatment 2013 Webinar Seminar Series • Andrew J. Saxon, MD protocols conducted, and CTN Training Update – consider design decisions Please join us for an engaging discussion on used as well as blinding and Site Management and Performance on adherence strategies. The presentation will also address th at 1:00 pm ET, with Wednesday, May 29 regulatory aspects for Dr. Greg Brigham, Ms. Dorothy Sandstrom, and Mr. Al treatment models. Cohen. This 90-minute webinar will address success Social Media – Using Social In 2012 the CTN Webinar factors in site management and performance as site staff Media as a Clinical Trials series introduced the use of prepares for initiation and implementation of multi-site Research Tool, August 21, social media tools in clinical clinical trials. Additionally, there will be discussion on 2013 trials and how to develop a the various indicators for performance success. strategy to use those tools. • Erin Winstanley, PhD This one hour presentation The objectives are: • Gloria Miele, PhD will consider IRB guidelines • Review strategies for improving site management regarding use of social media in the conduct of research and performance success. trials and how to integrate • Understand the management of sites in the pre- these tools for study implementation, implementation, and closeout participant recruitment, phases of multi-site clinical trials. engagement, and follow-up. • Consider factors that contribute to the successful performance of a trial. NIDA Project Officer, Steve Sparenborg, at: [email protected], telephone (301) 496-4844. To register for this event, copy and paste the following link into your web browser and, once connected, follow Other CCC related questions and topics- Principal the registration instructions. Investigator, Robert Lindblad, at 301-251-1161, http://www.yourconferencecenter.com/r.aspx?p=1&a=U [email protected], or Eve Jelstrom, Project phxWlWXRmMXTE Director, at 301-251-1161, [email protected].

Upon completing your registration, you will receive an e- Baby News for CTNers mail confirmation that will include the dial-in number, The Ohio Valley Node congratulates Kim Ross at passcode, PIN and links to be used when joining your Maryhaven (CTP) on the birth of her daughter on May 9, event. If you have any problems with this link, please 2013. Congratulations! contact the trainers at [email protected]. From the Southwest Node - If you would like to participate in future trainings, please Alyssa Forcehimes, Investigator for SW contact CTN CCC Training Coordination at Node and Lead Project Director for CTN 0047, [email protected] for details on requesting welcomed a baby girl on May 13, 2013. Congratulations registration and to be added to our mailing list. to Alyssa and her family!

NEW! Are there topics you would like added to the CTN Web Seminar Series? Do you want to provide a Updates for this Bulletin should be sent to Carol Cushing at general comment about our training offerings? Do you [email protected] have suggestions for presenters or training needs? Please follow the link here: https://www.surveymonkey.com/s/CTNTrainingSuggesti Connect with NIDA through: onBox to provide your questions, suggestions, or general comments for training. If you would like to be

contacted by the CTN CCC Training Coordination staff, please provide your contact information with your feedback; otherwise, all suggestions are anonymous. 5