Clinical Trials Network - CTN Dissemination Library

CTN Bulletin

Clinical Trials Network

May 22, 2013 Volume 13 - 08

Trial Progress – Over 15,000!

Greater New York Node News The Greater New York Node held its semiannual Node and Stakeholders Meeting May 3rd at NYU School of Medicine. Participants included representatives from all of their Community Treatment Providers, New York University, Columbia University, Cornell University and The Rockefeller University, as well as leaders from the New York City Department of Health and Mental Hygiene, the New York City Health and Hospitals Corporation, the New York State Office of Alcoholism and Substance Abuse Services and the Northeast and Caribbean Basin ATTC. Drs. Betty Tai and Udi Ghitza joined from NIDA CCTN. Foci of the meeting included: (1) integrating and coordinating addictions screening and interventions across mainstream and specialty settings; (2) the use of technology to facilitate this; (3) scaling up and implementation research; and (4) an update on how addictions research and practice were sustained in the wake of Hurricane Sandy. Betty and Udi talked about leveraging the EHR (Electronic Health Record) to facilitate SBIRT in mainstream and addictions settings; Jennifer McNeely spoke on automated ACASI-administered screening instruments for mainstream settings; Ned Nunes presented key findings from CTN-0044 on web-based interventions; and Stan Sacks and Mike Chaple talked about training and implementation on a State-wide level. Ellie Grossman, Babak Tofighi and Helena Hansen discussed lessons learned from Hurricane Sandy, with a particular focus on sustaining methadone and buprenorphine services from the perspectives of both patients and providers.

Trial enrollment numbers reflect study information as of May 21, 2013. Open Studies • CTN 0048 – CURB (Cocaine Use Reduction with Buprenorphine). Enrolled 302 (N=300). Enrollment completed – Completed follow-up, data lock next. • CTN 0049 – Project HOPE (Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users). Enrolled 475 (N=800). • CTN 0050 – Long Term Follow-up to the CTN 0027 (START) Study. Enrolled 813 (N=1,267). • CTN 0052 – BRAC (Buspirone for RelapsePrevention in Adults with Cocaine Dependence). Enrolled 62 (N=60). Enrollment completed – in follow up phase. Total Enrolled All Studies: 15,905 CTN 0047 Locked Database! CTN 0047 – SMART-ED (Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments) started enrolling participants at 6 hospital emergency departments in October 2010. The study reached its target enrollment of 1,285 patients 16 months later in February 2012. The one-year follow up assessments were completed in February 2013. The database was locked on May 16, 2013. The Lead Investigator team is working on a final report to NIDA and the DSMB for September 2013. Congratulations to all!

Federal Offices Closed The CCTN office and NIDA will be closed on Monday, May 27, 2013, for the Memorial Day holiday observance

Delaware Valley Node Update Dr. George Woody, Node PI, gave a presentation at the APA annual conference, May 18-22, in San Francisco, California, entitled: “Co-morbidity and Practical Issues of Treatment in the NIDA Clinical Trials Network.” This presentation was co-authored by Dr. Tom McLellan and started with an overview of what we have learned about psychiatric co-morbidities and how we learned it, then moved on to the importance of substance use treatment for improving outcomes of other medical disorders, and ended with a discussion of how the Affordable Health Care Act and the new DSM-5 criteria might work together to facilitate the integration of treatment for substance use disorders with general healthcare.

CCC and DSC Closed The NIDA CCC (Clinical Coordinating Center) and DSC (Data and Statistics Center) offices at EMMES will be closed Monday, May 27, 2013 in observance of the Memorial Day Holiday. The DSC 2 Help Desk will not be available that day, but DSC staff will respond to your requests when the office reopens the next business day. 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.

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Ph.D., Director of ISAP’s Center for Advancing Longitudinal Drug Abuse Research (CALDAR), David Geffen School of Medicine at UCLA.

Pacific Node Update - Taipei Conference The biennial Conference Series to Promote Global Health is sponsored by 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 of drug abuse and HIV in Asian countries as reported by their representatives, featured strategies for meeting challenges posed by these problems, and promoted international collaborative work on the prevention and treatment of substance use and HIV in order to promote health in API and other populations.

Special guests at the April 2013 Taipei meeting of the Conference Series to Promote Global Health were (from left) (1) Yun Wang, M.D., PhD., Director, Center for Neuropsychiatric Research, National Health Research Institutes, Taiwan; (2) Wen-Ing Tsay, Director, Division of Controlled Drugs, Food and Drug Administration, Department of Health, Executive Yuan, Taiwan; (3) Barry J. Hoffer, M.D., Ph.D., Case Western Reserve University School of Medicine, USA; (4) GeneJack Wang, M.D., Stony Brook University, 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. Minister, Department of Health, Executive Yuan, Taiwan; (7) Gilberto Gerra, M.D., Chief, Drug Prevention and Health Branch, United Nations Office On Drugs and Crime (UNODC), Vienna; (8) Ing-Kang Ho, Ph.D., China Medical University Hospital, Taiwan; (9) Hsing-Jien Kung, Ph.D., President, National Health Research Institutes, Taiwan; (10) Jaw-Jou Kang, Ph.D., Director, Taiwan Food and Drug Administration, Department of Health, Executive Yuan, Taiwan; and (11) Yih-Ing Hser, Ph.D., University of California, Los Angeles, USA.

Drug use persists as a major problem that severely impacts the health of individuals and populations, locally and globally. The international Conference Series to Promote Global Health is designed to share research findings on substance abuse treatment and HIV prevention, stimulate international collaborations, particularly between the United States and API countries, and inform cultural aspects of treatment and prevention of substance abuse and HIV. These and upcoming activities are part of efforts to extend NIDA’s mission of promulgating research-based interventions to improve health services and promote health globally.

Future meetings will rotate among different locales in Asia, the Pacific Islands, and the United States. Planning for the 2015 conference is underway. Conference presentations and upcoming information will be posted at www.caldar.org.

Keynotes were delivered by Nora Volkow, M.D., NIDA Director, and Gilberto Gerra, M.D., Chief of the Drug Prevention and Health Branch for the United Nations Office on Drugs and Crime (UNODC). Local officials (Wen-Ta Chiu, M.D., Ph.D., Minister, Department of Health, Executive Yuan, Taiwan; Jaw-Jou Kang, Ph.D., Director, Taiwan Food and Drug Administration, Department of Health, Executive Yuan, Taiwan; HsingJien Kung, Ph.D., President, NHRI, Taiwan) opened the conference with a welcome to the participants, and NIDA officials (Wilson Compton, M.D., M.P.E., Jacques Normand, Ph.D., Betty Tai, Ph.D.) and many eminent researchers presented cutting-edge research findings and led discussions. Speakers from UCLA Integrated Substance Abuse Programs (ISAP) included Richard A. Rawson, Ph.D., and Walter Ling, M.D. This event was co-hosted by Yun Wang, Ph.D., Director, Center for Neuropsychiatric Research of NHRI, and Yih-Ing Hser,

New Funding Opportunities The following announcements may be of interest to those in the CTN:

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Integration and Analysis of Diverse HIV-Associated Data (R03) (RFA-MH-14-200)

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NIDA Research Center of Excellence Grant Program (P50) (PAR-13-222)

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Notice to Clarify Number of Applications Allowed per Institution for RFA-DA-14-004 Medications Development Centers of Excellence Cooperative Program (U54) (NOT-DA-13-027)

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Substance Use Disorders and Molecular Regulation of Brain Energy Utilization (R01)(RFA-DA-14-005)

New England Consortium Node News Roger D. Weiss, MD , Shelly F. Greenfield, MD, MPH, Hilary S. Connery, MD, PhD, Kevin Hill, MD, MHS, and R. Kathryn McHugh, PhD from the New England Consortium Node were all presenters at the McLean Hospital/Harvard Medical School “Addictions in 2013” Conference on May 10-11, 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.

Day Two of the conference was the North Dakota Addiction Counselor Association’s Spring Conference, at which Drs. Somoza and Winstanley provided presentations on novel medications to treat addiction, methadone, overdose prevention, barriers to MAT adoption and using social media. Approximately 76 people attended the first day and 68 people attended the second day.

New England Consortium Node members from SSTAR and AdCare treatment programs delivered presentations at the “Innovations in Addictions: Integrating Systems and Services” conference in Norwood, Massachusetts, on May 10, 2013. The Conference is supported by the Massachusetts Department of Public Health, Bureau of Substance Abuse Services (BSAS) with additional support provided by the AdCare Educational Institute, Inc. Genie Bailey, MD and Nancy Paull, MS, LADCI, delivered a presentation on Integrated Substance Abuse Treatment based on the experiences at SSTAR with providing Buprenorphine treatment in a Primary Clinic within a Federally Qualified Health Center. Patrice Muchowski, ScD and Susan Hillis, LICSW, CADCII, LADCI from AdCare Hospital were among a group of presenters who described the process of developing an Electronic Health Record (EHR) system, from vendor selection, implementation planning, and staff training, to and through the “go-live” point and including the current post-implementation reality.

Kurt Snyder (L-Heartview) and Eugene Somoza (R-Ohio Valley Node)

The timing of this conference is significant for two reasons. First, North Dakota recently passed legislation to allow Opioid Treatment Programs. Previously, North Dakota was one of only two states that did not allow methadone treatment, and North Dakota clinicians have very limited experience using addiction medications. There are 13 physicians in the State that can prescribe buprenorphine; however, local physicians report that only approximately 5 physicians are actually prescribing buprenorphine, and perhaps only 2-3 are accepting new patients. In preparation for this conference, Dr. Winstanley traveled to North Dakota in October 2012 and Kurt Snyder (Heartview’s CEO) facilitated meetings with key stakeholders in the State, including the Attorney General. This was an important step to ensure that science was considered as part of the decision of whether to enact legislation that would allow for OTPs. Secondly, this conference is important because North Dakota is in the middle of an oil boom. While the oil boom has brought economic prosperity to residents, it has not come without a cost – one of which is increasing rates of prescription opioid and heroin use. Hence, the demand for treatment for opioid dependence has increased.

Ohio Valley Node (OVN) Update Medication Assisted Treatment in North Dakota The Ohio Valley Node collaborated with their Community Treatment Program (CTP), Heartview, to plan a two-day conference on medication assisted treatment in Jamestown, North Dakota, at the State hospital. Day One of the conference was a two-track buprenorphine training. Track one was the PCSS-B Half and Half Buprenorphine Training for physicians that was sponsored by the OVN and the American Osteopathic Academy of Addiction Medicine. Track two was the NIDA/SAMHSA buprenoprhine blending product training for all non-physicians that was sponsored by the Central Rockies Addiction Technology Transfer Center.

The OVN is very thankful for the partnership with Heartview, as well as the American Osteopathic Academy of Addiction Medicine and the Central Rockies Addiction Technology Transfer Center that made this conference possible. As a result of the OVN’s trip in October 2012, Heartview’s physician was able to start prescribing Vivitrol, and we are hopeful that this conference will make a real difference in people’s path to recovery.

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mid- and late-career researchers). The NIH expects all programs to foster the participation of individuals from backgrounds underrepresented in biomedical and behavioral research, including individuals from underrepresented racial and ethnic groups, individuals with disabilities and persons from disadvantaged backgrounds. Therefore all applications must include plans to recruit a diverse group of students and faculty. Some examples of topics appropriate for this announcement include the following:

Western States Node News Congratulations to Elinore F. McCanceKatz, M.D., from UCSF in the Western States Node. Dr. McCance-Katz has been appointed as SAMHSA's (Substance Abuse and Mental Health Services Administration) first chief medical officer. In this capacity, she will provide medical-scientific expertise to SAMHSA's major behavioral health efforts, including those promoting the prevention of mental illnesses and substance use disorders, as well as the treatment and recovery of people living with these conditions.

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Dr. McCance-Katz will work with leading scientists in the field of behavioral health to ensure that SAMHSA advances effective, state-of-the-art, evidence-based approaches to promoting the Nation's behavioral health services. “As SAMHSA's Chief Medical Officer, Ellie will greatly enhance SAMHSA's ability to bring the best available medical science and clinical perspective to bear in promoting all aspects of the Nation's behavioral health,” said Administrator Pamela S. Hyde, J.D. Congratulations!

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OBSSR Funding Opportunity OBSSR (NIH Office of Behavioral and Social Sciences Research) announces that they are leading a trans-NIH funding opportunity announcement calling for short courses on innovative research methodologies in the behavioral and social sciences and includes Big Data.

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RFA-OD-13-009 Short Courses on Innovative Methodologies in the Behavioral and Social Sciences (R25) http://grants.nih.gov/grants/guide/rfa-files/RFAOD-13-009.html Letter of Intent Due Date: June 3, 2013 Application Due Date: July 3, 2013

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The NIH Research Education (R25) grant mechanism is designed to support the development of creative and innovative research education programs for the development of biomedical, behavioral, and clinical researchers, or for public education and outreach on health-related research to a variety of audiences. Applicants are expected to describe the learning objectives for the proposed short course, how the proposed course will enhance existing skills and capabilities of the target participants, and how the learning will be measured. Target participants include those just starting their careers (e.g., graduate/medical students, medical residents, postdoctoral scholars, early-career investigators) as well as established investigators who are interested in learning new methods to apply them in their area of research (e.g.,

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Mobile and wireless health (mHealth) methodologies for the conduct of BSSR. Innovations in dissemination and implementation research methodologies. Quasi-experimental designs and other designs that complement randomized controlled trial designs. “Big data” mining, pattern recognition, integration, visualization and analysis which encourage hypothesis testing or analysis of BSSR research questions. Merging multiple iterations of experimental or survey data that contain common data elements (e.g., two data sets that both contain the same measure of depression). Statistical matching methods to identify the same cases in different datasets. Innovations in community-engaged or communitybased, participatory research. Cost-benefit or cost-effectiveness analyses of behavioral, social, policy or public health initiatives. Innovative study designs, creative uses of existing data, and novel analytical approaches for crossnational comparisons of data relevant to health. Innovative methods for the analysis of longitudinal multidimensional data (e.g., growth curves) including issues related to missing data. Innovations in short, brief interventions and referrals to treatment (SBIRT) in medical and nonmedical settings. Methods to develop common data element approaches for integrative behavioral interventions. Methods to develop translational tools for integrative behavioral interventions. Algorithms for measuring the construction of short, brief interventions and referrals to treatment (SBIRT) measurement and/or methods to evaluate the effectiveness of research delivery models in medical and non-medical settings.

See the full announcement at: http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-13009.html

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For your calendar, we have the following training webinars scheduled for the rest of the year:

Pacific Northwest Node News Congratulations to Co-PI, Dr. John Roll, on his new appointment. Dr. Roll will assume a new role as Washington State University Spokane's senior vice chancellor for academic affairs and research effective July 1. Clinical Coordinating Center (CCC) at EMMES 2013 Webinar Seminar Series CTN Training Update – Please join us for an engaging discussion on Site Management and Performance on Wednesday, May 29th at 1:00 pm ET, with Dr. Greg Brigham, Ms. Dorothy Sandstrom, and Mr. Al Cohen. This 90-minute webinar will address success factors in site management and performance as site staff prepares for initiation and implementation of multi-site clinical trials. Additionally, there will be discussion on the various indicators for performance success.

Topic/Date/Presenters

Webinar Description

Developing Medication Assisted Treatment (MAT) Protocols, July 17, 2013

This one hour presentation will review some of the lessons learned from prior medication assisted treatment protocols conducted, and consider design decisions used as well as blinding and adherence strategies. The presentation will also address regulatory aspects for treatment models. In 2012 the CTN Webinar series introduced the use of social media tools in clinical trials and how to develop a strategy to use those tools. This one hour presentation will consider IRB guidelines regarding use of social media in the conduct of research trials and how to integrate these tools for study participant recruitment, engagement, and follow-up.

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Andrew J. Saxon, MD

Social Media – Using Social Media as a Clinical Trials Research Tool, August 21, 2013 • •

The objectives are: • Review strategies for improving site management and performance success. • Understand the management of sites in the preimplementation, implementation, and closeout phases of multi-site clinical trials. • Consider factors that contribute to the successful performance of a trial.

Erin Winstanley, PhD Gloria Miele, PhD

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 the registration instructions. http://www.yourconferencecenter.com/r.aspx?p=1&a=U phxWlWXRmMXTE

Other CCC related questions and topics- Principal Investigator, Robert Lindblad, at 301-251-1161, [email protected], or Eve Jelstrom, Project Director, at 301-251-1161, [email protected].

Upon completing your registration, you will receive an email confirmation that will include the dial-in number, passcode, PIN and links to be used when joining your event. If you have any problems with this link, please contact the trainers at [email protected].

Baby News for CTNers The Ohio Valley Node congratulates Kim Ross at Maryhaven (CTP) on the birth of her daughter on May 9, 2013. Congratulations!

If you would like to participate in future trainings, please contact CTN CCC Training Coordination at [email protected] for details on requesting registration and to be added to our mailing list.

From the Southwest Node Alyssa Forcehimes, Investigator for SW Node and Lead Project Director for CTN 0047, welcomed a baby girl on May 13, 2013. Congratulations 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 general comment about our training offerings? Do you have suggestions for presenters or training needs? Please follow the link here: https://www.surveymonkey.com/s/CTNTrainingSuggesti 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.

Updates for this Bulletin should be sent to Carol Cushing at [email protected]

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