CTN Bulletin Clinical Trials July 3, 2013 Network Volume 13 - 10

Trial Progress – Over 15,000! NIDA’s Mobile Site Named by Marketwatch as One of the “10 Apps That Could Save Your Life” Trial enrollment numbers reflect study The Wall Street Journal’s MarketWatch recently named information as of July 2, 2013. NIDA’s mobile-compatible website as one of the “10 apps that could save your life.” NIDA’s website, Open Studies drugabuse.gov, adapts to fit smartphone and tablet • CTN 0049 – Project HOPE (Hospital Visit as screens, thereby allowing for quick and easy access to Opportunity for Prevention and Engagement for scientific facts about drugs and drug . Materials HIV-Infected Drug Users). Enrolled 529 (N=800). can also be downloaded onto the Kindle, Nook or other • CTN 0050 – Long Term Follow-up to the CTN E-book. Check the apps out below! 0027 (START) Study. Enrolled 826 (N=1,267). • CTN 0052 – BRAC (Buspirone for Relapse- Prevention in Adults with Cocaine Dependence). Enrolled 62 (N=60). Enrollment completed – in follow up phase.

Total Enrolled All Studies: 15,972

CTN 0048 CURB Locked Database! The CTN 0048 Cocaine Use Reduction with Buprenorphine (CURB) study database was locked on June 7, 2013. CURB began enrollment in September 2011, recruiting 302 participants across 11 participating treatment programs. Patient recruitment was completed in November 2012, and data collection was completed in March 2013. The aim of this study was to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence. The study is led by Dr. Walter Ling, Principal Investigator of the Pacific Node. The Lead Team is now working on the final study report. Congratulations to the entire study team!

Request for Information NIDA needs to keep track of the number of grants that use CTN as a platform. Our current information is limited. Please let us know of any funded R01, K23, R03, R21, or other grants using CTN as a platform. Send the information to Quandra Scudder at: [email protected]. Thanks!

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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New Funding Opportunities Dr. Nora Volkow Joins President Bill Clinton for The following announcements may be Prescription Drug Abuse Panel Discussion of interest to those in the CTN: On May 6th, NIDA Director Dr. Nora Volkow joined former President Bill Clinton, New York dignitaries, and • Notice of Intent to Publish a Funding Opportunity college students from for a panel Announcement for the NIH Health Care Systems discussion on prescription drug abuse, particularly Research Collaboratory - Demonstration Projects for among 18 – 26 year olds, and how the Clinton Pragmatic Clinical Trials Focusing on Multiple Foundation’s Clinton Health Matters Initiative can work Chronic Conditions (UH2/UH3) with others to contribute to solutions in New York and http://grants.nih.gov/grants/guide/notice-files/NOT- nationwide. Featured speakers included President Bill RM-13-022.html Clinton, NYC Police Commissioner Ray Kelly, NYU President Dr. John Sexton as well as NIDA Director Dr. • HIV/AIDS and Substance Use Among the Homeless Nora Volkow. The event was moderated by Melinda and Unstably Housed (R01) Beck, columnist for the Wall Street Journal. (RFA-DA-14-009)

• HIV/AIDS and Substance Use among Black/African American Women and Young MSM (R01) (RFA-DA-14-010)

• Integrating Substance Abuse Prevention and Treatment within HIV/AIDS Service Delivery Settings (R01) (RFA-DA-14-011) Comorbid HIV, Chronic Pain, and Substance Use among Older Adults (R21) (RFA-DA-14-012) Application Receipt Date(s): November 15, 2013

• The Patient-Centered Outcomes Research Institute Photo credit ©NYU Photo Bureau: Hollenshead (PCORI) is authorized by Congress to conduct Caption: L to R: President Bill Clinton, Dr. Nora Volkow, NYC Police Commissioner Ray Kelly, and NYU President Dr. John Sexton research to provide information about the best available evidence to help patients and their health Wanted: Data for a Confirmatory Study of the care providers make more informed decisions. START CTN-0027 Genetics Findings PCORI’s research is intended to give patients a Analyses of the START data identified pharmacogenetic better understanding of the prevention, treatment results related to polymorphisms in the delta- and care options available, and the science that opioid receptor gene for both African supports those options. American participants and for European http://www.pcori.org/funding-opportunities/funding- American female participants. These results announcements/upcoming-opportunities/ require confirmation. START investigators are looking for appropriate existing data they could use to validate News from the Greater NY Node their results. Blood samples and weekly urine drug The New York Node has received word that screen data and self-reported substance use (either the 8th paper from the Infections and existing or prospectively collected) from African Substance Abuse Study (NIDA CTN-0012) Americans and European American females with DSM-5 has been loaded into PubMed Central. The opioid use disorders receiving medication assisted manuscript: "Hepatitis B Virus and Hepatitis C Virus treatment (buprenorphine/naloxone, methadone) for at Services Offered by Substance Abuse Treatment least 16 weeks would be analyzed. The primary outcome Programs in the United States" (NIHMS328851) can be will be proportion of opioid positive urine specimens viewed at the following link: collected during the final 8 weeks of treatment. It is http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272317/ expected that approximately 100 African Americans and 200 European American females study completers would Authors of this paper were: Edmund J Bini, MD, MPH, be needed in each medication condition to have adequate Steven Kritz, MD, Lawrence S. Brown, Jr., MD, MPH power to confirm the original observations. For more (Lead Investigator), Jim Robinson, MEd, Donald Calsyn, information, please contact Wade Berrettini, MD, PhD, PhD, Don Alderson,MS, Kathlene Tracy, PhD, Patrick Director, Center for Neurobiology and Behavior, McAuliffe, MBA, LADC, Cheryl Smith, MD, and John University of Pennsylvania Perelman School of Rotrosen, MD (Co-PI of the Greater NY Node). Medicine: [email protected], 215-898-0092, 484-432-5836.

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Texas Node News Clinical Coordinating Center (CCC) at EMMES The Texas Node, in close CTN Investigator Toolbox collaboration with two of their What’s New! The NIDA CCC has added Community Treatment Programs, new tools to the Investigator Toolbox on the Nexus Recovery Center, Inc. and DSC’s TPR website at Homeward Bound, Inc., held their http://www.ctndsc2.com/: second annual Texas Addiction Research to Practice Dissemination • Pre-Implementation Timeline Calculator and Conference in Dallas on April 26, 2013. This conference Instructions – Thanks to Dr. Theresa Winhusen and was free to attendees, and Nexus provided continuing the Ohio Valley Node Team, the CTN has a useful education credits at no charge to attendees. tool to develop a timeline for critical milestones in the pre-implementation planning of protocols. To keep costs low, they limited the conference to three Using this tool, investigators can track progress topics, with three morning didactic sessions followed by towards the target date for site initiation. afternoon experiential sessions for two topics. They achieved maximum capacity, with 85 attendees at the • Study Budget Calculator – Are you are a lead morning sessions and 30 in each of the concurrent investigator needing to develop and submit a budget afternoon experiential learning sessions. Dr. Scott to the CCTN? You need the Study Budget Walters discussed eliciting, identifying, and responding Calculator. This tool is an MS Excel document that to change talk in motivational interviewing in a morning lays out a framework for projecting study costs session for all attendees with some experiential intuitively, as they relate to the Lead Node, RRTC, components, followed by a fully experiential afternoon and site/CTP. While the framework is a good breakout session in which attendees further learned, starting point, investigators are encouraged to add practiced, and developed new skills related to engaging the necessary details as they apply to each protocol. clients’ change talk. Reference the Protocol Development section of the Dr. Angela Stotts discussed Acceptance and Investigator Toolbox to obtain your own copy of each Commitment Therapy (ACT) as it applies to , tool. including her studies using ACT for patients undergoing opioid detoxification, followed by an experiential 2013 Webinar Seminar Series breakout session in which attendees learned more about CTN Training Update – the underlying principles of ACT and had the Please join the next CTN Web opportunity to practice and experience ACT introductory Seminar on “Developing Medication skills. Assisted Treatment (MAT) Protocols,” presented by Andrew Dr. Sidarth Wakhlu presented a thorough review of Saxon, MD on Wednesday, July 17, 2013 at 1:00 pm medication assisted therapies and fielded numerous ET. This one-hour presentation will examine design and questions from the audience. CTN Dissemination implementation issues related to medication assisted Librarians posted the materials after the conference for treatment protocols, masking strategies, and regulatory attendees to download on their own, helping increase the considerations for treatment models. We encourage all visibility of the CTN Dissemination Library to attendees. interested to attend.

Two VA hospital systems in the Texas Node An e-mail invitation will be sent to the CTN mailing list (VA North Texas Health Care System within the next week. Follow the instructions given to and South Texas Veterans Health Care register. If you have any problems with this link, please System, i.e., the VAs in Dallas and San contact CTN Training Coordination at Antonio, respectively) have been awarded [email protected]. If you would like to a VA Interprofessional Advanced participate in this webinar or future trainings and have Fellowship in Addiction Treatment. This two-year not signed up to our member list, please contact CTN fellowship is designed to develop our future leaders in CCC Training Coordination at [email protected] the addictions. The Dallas site (PIs: Bryon Adinoff and to request registration assistance and to be added to their Jody Rubenstein) will be recruiting one physician and mailing list. one psychologist, and the San Antonio site (PIs: Michael Dawes and Troy Moore) will be recruiting one physician Other CCC related questions and topics- Principal and one psychologist or PharmD annually. Investigator, Robert Lindblad, at 301-251-1161, [email protected], or Eve Jelstrom, Project Director, at 301-251-1161, [email protected]

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CTN International Activities during the NIDA New Summer Intern at NIDA CTN International Forum at CPDD In mid-June, the Center for the Clinical CTNers were busy at the recent CPDD (College Trials Network at NIDA welcomed Kevin on Problems of Drug Dependency) annual Hamill, its new summer intern. Kevin meeting in San Diego, California, last month. recently graduated from the Georgetown Here is a recap of the International Forum: Preparatory School and is entering the University of Virginia in Charlottesville this fall. An avid soccer, golf, 1. Geetha Subramanian chaired a workshop: “What is movie, music, and literature fan, Kevin will assist the SBIRT and Why?” In this session, presenters (Drs. team in publishing a special edition of the CTN Bulletin Redonna Chandler, Geetha Subramanian, Gail focused on drug abuse and addiction among minority D’Onofrio and Robert Ali) reviewed recent populations. The CTN and Kevin look forward to a great evidence, highlighted the need for more empirical and enriching summer! Look for the special CTN data, and described new health information Bulletin edition next month! technology tools for substance use screening. Dr. Betty Tai wrapped up the workshop discussing the Federal Guidelines for Opioid Treatment - Comment Role of Health Information Technology in SBIRT. You can now comment on the Federal Guidelines for Opioid Treatment. This 2. Carmen Rosa and Petra Jacobs chaired a session: preliminary set of guidelines provides “Using the Clinical Trials Network (CTN) Model To detailed information to opioid treatment Improve Treatment.” This session included programs (OTPs) and accreditation organizations about presenters from Ukraine CTN INVEST– Fellow what they need to comply with new requirements under Sergey Dvoriak, Mexico – Rodrigo Marin, NIP, and the Code of Federal Regulations (42 CFR Part 8). View the Opioid Treatment Guidelines [PDF - 982 KB] Canada– Evan Wood, UBC and Nathalie Gendron, CIHR, to discuss the approaches and advances As part of efforts to finalize the guidelines, made towards establishing evidence-based representatives from OTPs, accreditation organizations, treatments in drug treatment centers in their patient groups, the medical community, and interested countries. Drs. George Woody, Walter Ling and members of the public are asked to review and comment Betty Tai were the discussants. on these preliminary guidelines.

3. Richard Rawson (UCLA) and Traci Rieckmann All comments submitted by the deadline, July 16, 2013, (OHSU) chaired a session: “Using Performance and will be carefully considered. Email Your Comments Outcome Data to Improve Treatment.” In this [[email protected]] session four different models for using data to measure/ assess and improve treatment services EMMES Offices Closed were presented. The panel included presenters from The NIDA CCC (Clinical Coordinating Canada, Republic of South Africa, Vietnam, and the Center) and DSC (Data and Statistics United States. Center) offices at EMMES will be closed Thursday, July 4, 2013 in observance of 4. Walter Ling (UCLA) chaired a panel: “Cochrane the Independence Day holiday. The DSC 2 Help Desk and the Practice of Addiction Medicine: An will not be available that day, but DSC staff will respond International Perspective.” Presenters explored the to your requests when the office reopens the next impact of the Cochrane Collaboration systematic business day. reviews of evidence-based interventions on international treatment guidelines for addiction Federal Offices Also Closed medicine and the potential influence of U.S. health The CCTN office and NIDA will be closed on Thursday, care reforms on the Cochrane model. July 4, 2013, for the Independence Day holiday observance too. 5. George Woody chaired a symposium: “Emerging Data on Efficacy and Clinical Applications of Extended-Release Naltrexone Formulations.” Updates for this Bulletin should be sent to Carol Cushing at Researchers from several countries (Russia, [email protected]

Norway, Iceland, and Australia) presented results on Connect with NIDA through: several studies using extended release naltrexone for the treatment and management of opioid, amphetamine and alcohol dependence. Dr. Kathleen

Brady (University of South Carolina) was the discussant for this session. 4