Minutes of the 101st Meeting of the National Advisory Council on Drug Abuse

February 3-4, 2009

The National Advisory Council on Drug Abuse convened its 101st meeting at 2:00 p.m. on February 3, 2009 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director of NIDA, chaired the overall meeting and Dr. Timothy P. Condon, Deputy Director of NIDA, chaired the review of applications. The closed portion of the meeting on February 3, 2009, from 2:00 p.m. until 4:30 p.m., was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open session, which was open to the public, was February 4, 2009, from 8:30 a.m. until 1:00 p.m. The Council adjourned on February 4, 2009 at 1:00 p.m.

Council Members Present:

Louis E. Baxter, M.D.
Warren K. Bickel, Ph.D.
Francisco X. Castellanos, M.D.
Steven R. Childers, Ph.D.
Thomas J. Crowley, M.D.
Debra K. DePrato, M.D.
Anita S. Everett, M.D.
Igor Grant, M.D.
Eric J. Nestler, Ph.D., M.D.
Daniele Piomelli, Ph.D.
Mary Jane Rotheram-Borus, Ph.D.
Ellie E. Schoenbaum, M.D.
James L. Sorensen, Ph.D.
Hazel H. Szeto, Ph.D., M.D.
R. Dale Walker, M.D.
Marina E. Wolf, Ph.D.
Janet Wood, MBA
Xiaoyan Zhang, Ph.D.

Council Members Absent:

John P. Allen, Ph.D., M.P.A.

Council Chairs Present:

Nora D. Volkow, M.D.
Timothy Condon, Ph.D.

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:

Matthew Aumen - NASADAD
Lizbet Boroughs, MSPH - American Psychiatric Association
Anne Bowen - Masimax Resources
Helen Cesari, M.S.C. - CSR, Inc.
Marshall Cohen
Jenn Columbel - National Association of Drug Court Professionals
William Corrigall, Ph.D.
Andrea DeSanti - Social and Scientific Systems
Stacia Hall Fleisher, M.P.P. - American Academy of Child and Adolescent Psychiatry
Rick Hansen, M.S. - Digicon Corp.
Andrew Kessler, Ph.D. - CAADAC
Marian Kratage, M.S. - MasiMax Resources
LouAnn Maier - MaxiMax Resources
Sarah Mandell, Ph.D. - Society for Research in Child Development
Meghan McGowan - Federation of Behavioral Psychological and Cognitive Sciences
Eileen McGrath, J.D. - American Society of Addiction Medicine
Julie Miller, Ph.D. - Masimax Resources, Inc.
Geoff Mumford, Ph.D. - American Psychological Association
Amy Pollick, Ph.D. - Association for Psychological Science
Patricia President - CSR
Darrel Regier, M.D. - American Psychiatric Association
Trina Stevens - Masimax Resources, Inc.
Lori Whitten, Ph.D. - Masimax Resources, Inc.
Joan Levy Zlotnik, Ph.D., A.C.S.W. - Institute for the Advancement of Social Work Research

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. Timothy Condon, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. Dr. Condon provided an overview of the agenda for the meeting and reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.

   Dr. Teresa Levitin, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   In turn, the Director or a designee for the Division of Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse; the Office of Science Policy and Communications; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; and the AIDS Research Program presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc.

   Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave if an application in conflict with that member was acted upon en bloc.

   For this Council, 840 applications, requesting $827,413,464 in Total Years Direct Costs, went to review. Of these, 412 were scored by the Scientific Review Groups (SRGs) representing $102,126,567 in First Year Direct Costs and $421,881,108 Total Years Direct Costs. Council concurred with the SRGs in time and amount.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members. She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. Dr. Volkow called attention to future Council meetings: May 12, 2009, September 15-16, 2009; February 2-3, 2010.

2. Consideration of the Minutes of Council

   The Minutes of the September 2008 meeting were approved as written.

3. NIDA Director's Report - Nora D. Volkow, M.D., Director, NIDA

   Dr. Volkow began her report with a budget update, noting a -0.7% decrease over the prior year in the 2009 C.R. She then turned to an overview of what is new at NIH, including the appointment of Dr. Raynard Kington as Acting NIH Director and Dr. Lawrence Tabak as Acting NIH Deputy Director. She also summarized the implementation plans for enhancing peer review, pointing out that the process had begun with a diagnostic phase and had moved into the design phase and was now in the implementation of selected actions phase. The Peer Review Oversight Committee managing this process had established four working groups to maximize the enhancement process and outcome. The groups focused on ways to 1) engage the best reviewers; 2) improve the quality and transparency of review; 3) ensure balanced and fair reviews across scientific fields and career stages; and 4) ensure continuous review and evaluation of peer review. In order to engage the best reviewers, there will be training for reviewers and NIH staff on changes in peer review, and pilots will be conducted on the feasibility of virtual reviews to provide more flexibility for reviewers. In order to improve the quality and transparency of review, a new scoring system will be implemented, and all applications will receive scores on each review criterion in addition to critiques in order to help applicants assess whether or not they should resubmit. Further, applications will be shorter and restructured. Priority 3 will be realized by reducing the number of resubmissions from two to one; identifying early stage investigators and establishing goals to encourage funding for new and early stage investigators; and, where possible, NIH will cluster new applications for review.

   Dr. Volkow then described the Research, Condition, and Disease Categorization (RCDC) Project to promote consistency, transparency and reproducibility, and noted that a more detailed report on this project will be presented at a later Council meeting.

   Recent NIDA activities include the transfer of the preclinical medications development applications from review at NIDA to review at CSR and initiation of the process of transfer to CSR of the Behavioral Treatment Branch applications. The NIDA Prevention Research Review Workgroup, chaired by Dr. Mark T. Greenberg, is continuing to meet and will report its findings at the May Council meeting.

   Dr. Volkow then highlighted activities from each Center/Division. For the Center for the Clinical Trials Network, she highlighted CTN-0029, a pilot study of osmotic-release methylphenidate (OROS-MPH) in initiating and maintaining abstinence in smokers with attention deficit hyperactivity disorder (ADHD). The trial has been completed as has the primary data analysis. The Scientific Director Administrative Review for Dr. Barry Hoffer of the Intramural Research Program was completed, and it was noted that later in the day Dr. Hoffer would report his responses to the Review Committee's recommendations. For the Division of Epidemiology, Services and Prevention Research, Dr. Volkow provided data on the percentage of U.S. 12th grade students reporting past month use of cigarettes and marijuana. She also described three new announcements. In the Division of Pharmacotherapies and Medical Consequences of Drug Abuse, Dr. David McCann is serving as Acting Director with the retirement of Dr. Vocci as the Director of that Division. A search is underway for a new Director. The announcement for Medication Development Centers of Excellence was described. Dr. Volkow noted several announcements from the Division of Basic Neurosciences and Behavior Research, including an RFA with NINDS and NIDCR to encourage research on CNS changes that occur with chronic pain, including the ways these changes parallel those occurring with drug addiction. Also, there will be several grand challenge initiatives associated with the NIH neuroscience blueprint; they will be on aspects of pain (harnessing understanding of neural plasticity to elucidate the transition from acute to chronic pain), imaging (seeing connections and molecules in human neuroimaging) and neurotherapeutics (new therapies for diseases of the nervous system). For the Division of Clinical Neuroscience and Behavioral Research, Dr. Volkow described an RFA on brain imaging and drug use prevention messages that required collaborative teams of brain imaging and prevention message investigators. It yielded three funded applications. She then summarized some research on differential brain activation by message sensation value. Several announcements were also highlighted. Dr. Volkow then noted that the second competition for the NIDA Avant Garde award is underway and that there was a successful workshop on epigenetics, HIV/AIDS and drug abuse in January.

   In other news, Dr. Christine Colvis has been appointed to a new position, Director of Program Integration. In this position she will be facilitating collaboration across NIDA's Divisions, Offices and Centers, as well as across the NIH with an emphasis on program development, and she will continue to represent NIDA on a number of trans-NIH program teams. NIDA and NIAAA are participating in a new program to supplement new investigators who have support from sources other than the NIH to conduct research in basic or clinical alcohol or drug abuse research. It is called Support Opportunity for Addiction Research (SOAR) for New Investigators. A new RFA to explore the interactions between physical activity and drug abuse was described. Dr. Volkow also noted that a meeting was held in January with the U.S. Department of Defense and the Department of Veterans Affairs as well as several other NIH Institutes to look at problems of trauma, stress and substance abuse and comorbidities among military personnel, veterans and their families. NIDA also recently released a report on comorbidity as part of its research report series. Dr. Volkow concluded by noting that an IOM report published in 2003 suggested further study on the merger of NIDA and NIAAA and the NIH Reform Act of 2006 established a Scientific Management Review Board to conduct periodic organizational reviews.

   Council thanked Dr. Volkow for her report. Several issues were raised, including the possible consequences for new investigators of having only one resubmission opportunity, concern about the review of behavioral treatment applications at CSR, the importance of forming collaborations with other agencies, the suggestion that Israeli research on trauma and PTSD might inform research at NIDA, the importance of research on pain, the absence of an adequate animal model for chronic pain, and the importance of considering the intersection of depression, chronic stress and chronic pain. It was also noted that the Bureau of Indian Affairs might offer important collaborative opportunities in prevention and other areas and that agencies such as the Department of Commerce/Census Bureau could also be valuable resources. There were also comments about merging NIDA and NIAAA, both from the perspective of the different patient populations and available resources. The importance of maintaining funding while blending science was noted. Council also noted that it should be actively involved in any merger activities.

4. Clinical Translational Science Awards - Barbara Alving, M.D., M.A.C.P., Director, National Center for Research Resources, NIH

   Dr. Barbara Alving noted the importance of accelerating research from basic discovery to improved patient care and pointed out that the impetus for the Clinical and Translational Science Awards (CTSAs) was to ensure that new discoveries would lead to improved public health. She noted that in order to do so, clinical science must evolve to better implement biomedical discoveries; develop, test and bring new prevention strategies into medical practice more rapidly, catalyze change and encourage creative and innovative approaches.

   The CTSAs, in building a national consortium of academic health centers, with 38 sites across the country, is providing local leveraging opportunities, creating national partnership opportunities and otherwise working toward national strategic plan priorities. Dr. Alving described the four goals that comprise the CTSA national strategic plan: 1) enhancing national clinical and translational research capability, 2) enhancing the training and career development of clinical and translational investigators, 3) enhancing consortium-wide collaborations and 4) enhancing the health of our communities and the nation. She then described ways to realize these goals and noted that a committee structure has been established to execute that vision and goals of the CTSA program She described a variety of resources available on the CTSA webpage, noted the types of regional partnership opportunities that have been developed, showed how clinical and translational information exchange environment informatics pilots are encouraging and enhancing collaboration Dr. Alving then described the informatics pilot projects in more detail, noting the investigators and purposes of each project.

   The CTSA consortium is building connections with business schools to achieve a number of goals, including developing business plans and designing and implementing community surveys, creating innovative cross-educational programs, and preparing cost analyses. Further, to encourage and enhance collaboration, there are CTSA thematic research networks/CTSA interest groups in emergency medicine, sleep research, critical care, neurology and neuroimaging.

   Dr. Alving noted the educational impact of the CTSA, which has included doubling the clinical and translational training workforce from 2006-2008, increasing the number of regional training interactions among consortium sites and the awarding of a supplement to develop a National CTSA Educational Resource Program to identify, catalog and assess training modules in clinical and translational research as well as enhance and broaden training opportunities for clinician-scientists across the CTSA consortium.

   Dr. Alving concluded by noting CTSA and NIDA collaborations, identifying the number of NIDA grants using the CTSAs and suggesting how the NIDA Clinical Trials Network can work with the CTSAs to enhance the bidirectional partnership of NIDA and the CTSAs.

   Council thanked Dr. Alving for her presentation and asked for more information about NIDA-CTSA collaborations. Council members described their positive experiences in being part of CTSAs as well as applying for CTSAs, noting both positive institutional and business practices changes as well as the benefits of social networking. There was also discussion about the kinds of people who are supported and trained as part of a CTSA and the interdisciplinary focus of that training as well as the importance of leveraging core resources at facilities.

5. Mainstreaming Addictions in Medicine: Update on NIDA's SBIRT Efforts in General Medical Settings - Wilson Compton, M.D., M.P.E., Director, Division of Epidemiology, Services & Prevention Branch, NIDA

   Dr. Wilson Compton provided an update on NIDA's Screening Brief Intervention Referral to Treatment (SBIRT) efforts in general medical settings. He noted that the U.S. Preventive Services Task Force (USPTF) has accepted SBIRT for alcohol and tobacco but stated in a 2008 report update that the "evidence is insufficient to determine the benefits and harms of screening for illicit drug use." Dr. Compton presented the USPTF model, noting that evidence is needed that intervention impacts long-term morbidity and mortality within primary care populations and describing accepted outcomes for SBIRT. He provided an analytic framework and key questions as well as an example of the strength of evidence for 1) alcohol and 2) tobacco/smoking. The strength of evidence for illicit drugs is promising, but results are sparse. Data on brief motivational intervention in reducing cocaine and heroin use were presented, as were the results of other studies, including the WHO ASSIST Phase III Technical Report and a SAMHSA demonstration program for SBIRT.

   Dr. Compton then turned to NIDA SBIRT initiatives, including an RFA in 2008 that yielded four funded grants to test the effectiveness of various SBIRT models. He also cited SBIR and STTR grants and noted that a resource guide for providers on screening and brief intervention for drug use in primary care settings was in preparation. This guide targets adult primary care with a key goal of increasing screening for illicit drug abuse, and provides a clinician-friendly format to support screening and brief intervention and strengthens clinicians' ability to discuss screening results with patients, among other features. It will be available on the NIDA website, and will be similar to the NIAAA guide with which general medical clinicians are already familiar to facilitate adoption. Dr. Compton provided additional detail about the screening and brief intervention for drug use in primary care settings that will serve as a resource guide for providers. It has been developed by NIDA staff and peer-reviewed by university-based experts and features collaboration with representatives from WHO, ONDCP, SAMHSA, CDC and NIAAA. NIDA will also offer a screening resource pocket guide to facilitate implementation.

   Dr. Compton then described additional NIDA-SBIRT initiatives, including cooperative actions with other public health agencies such as WHO and the AMA. He noted areas for future SBIRT research, including enhancing the evidence base regarding effectiveness in a variety of medical and related settings, working with new technologies and developing models for referral and/or direct care in general medical settings. Dr. Compton summarized his presentation by noting that 1) SBIRT is efficacious for alcohol and tobacco, while evidence for illicit drugs is promising but not yet sufficient, 2) NIDA has numerous initiatives to enhance the evidence base and to disseminate SBIRT training to medical professionals, and 3) NIDA's collaborations with other organizations/agencies is key to this process.

   Council thanked Dr. Compton for his presentation. It was noted that Colorado is a SBIRT state and has made some innovations such as training chaplains within the National Guard to serve as screeners. Questions were also raised about how to decide who receives the brief intervention and who gets referred, about using the CTN to include primary medical care and to serve as a resource for dissemination and referral to treatment, about the use of trauma or primary care settings, about linking with a CTSA, about the importance of referral to treatment, and about the consequences of self-reporting of the use of illegal substances and the safeguards needed, including safeguards with electronic medical records.

6. Intramural Research Program Administrative Review Board - Barry Hoffer, M.D., Ph.D., Director, Division of Intramural, Research, NIDA

   Dr. Barry Hoffer began his presentation by noting that on April of 2008, Dr. Nora Volkow convened the NIDA Scientific Director Administrative Review Committee, composed of members from the National Advisory Council on Drug Abuse and prominent scientists from the drug abuse and addiction field, and charged them to provide an administrative review of Dr. Hoffer's contributions as Scientific Director of NIDA's Intramural Research Program (IRP). Dr. Daniele Piomelli chaired the committee. The report was, overall, very positive in its assessment of the IRP and the role of Dr. Hoffer in leading it.

   Nevertheless, the Committee made recommendations on ways to further improve the IRP in three areas: communication and cooperation; conducting human research on drug abuse; and cultural diversity among IRP researchers. Dr. Hoffer then described both the specific recommendations in each of these three areas and the actions that have been, or will be, taken to address the specific recommendations. For example, in the area of communication and cooperation, the Committee recommended that the IRP increase the transparency of the decision making process, increase chance interactions among IRP scientists and use the tools of social network analysis to enhance interaction among IRP scientists. In response, Dr. Hoffer listed nearly 20 separate actions, including, for example, the establishment of quarterly town hall meetings for all IRP staff, advertising weekly "clinical rounds" talks to the entire staff, and encouraging maximum participation in interest groups, seminars, symposia and related activities.

   In the area of conducting human research on drug abuse, the recommendations included improving recruitment for protocols, improving interactions with the NIH Institutional Review Board, enhancing supervision of the contract with the Maryland Psychiatric Research Center (MPRC), extending collaborations with clinical investigators at other NIH Institutes for more effective use of the NIH Clinical Center and considering alternative venues for clinical research. Dr. Hoffer described a large number of actions to improve recruiting for protocols, including the expansion of shopping mall-based outreach, and the identification of areas in the screening process that could be made more efficient and work better for the research candidate as well as for the NIDA study teams. Dr. Hoffer noted that the implementation of several techniques has resulted in the number of protocols and the number of participants increasing in every study.

   Actions such as regular meetings between the Clinical Director and/or Deputy Director and the Chair of the IRB and the completion of a Memorandum of Understanding for providing support to the Chair of the IRB are improving IRB interactions. Actions to enhance supervision of the contract with the Maryland Psychiatric Research Center include Dr. Hoffer meeting with the management officials from the MPRC to clarify expectations, and the creation of a Scientific Liaison position to work on integrating areas and determining commonalities of research between NIDA and MPRC clinical and preclinical work. NIDA and MPRC are collaborating on a number of activities that will yield important research results. Dr. Hoffer presented 12 collaborative protocols addressing a dual-diagnosed population that are currently being conducted at MPRC as well as a substantial number of other specific activities intended to enhance supervision of the contract with MPRC.

   Several activities, such as developing a collaboration with NIDDK on a project looking at addiction in relation to obesity, were listed as actions to extend collaborations with clinical investigators at other NIH Institutes to better use the resources of the NIH Clinical Center. Actions to consider alternative venues were also listed and included a number of new studies with new colleagues.

   The Committee emphasized that Dr. Hoffer has done a tremendous job at supporting the scientific success of minority researchers within the IRP. Nonetheless, it was noted that, given lingering perceptions regarding cultural diversity at the NIH, it is important that Dr. Hoffer continue to maintain a high level of vigilance on this delicate issue. Dr. Hoffer offered several actions for doing so, including securing funding for four additional minority trainees and continuing to support a minority summer student program.

   Council thanked Dr. Hoffer for his presentation and asked about scientific interactions with other IRPs. Dr. Hoffer provided information about meetings and interactions.

7. Operational Procedures and Statement of Understanding - Teresa Levitin, Ph.D., Director, Office of Extramural, Affairs, NIDA

   Dr. Teresa Levitin reminded the Council members that it is NIH policy for Councils to review their operating procedures and delegation of authority once a year and that the NIDA Advisory Council does so at the February meeting each year. She noted that the materials had been sent to them prior to this meeting for their review and asked if there were any questions or comments. Dr. Levitin further pointed out that this document was not intended to describe all the activities of the Council. Rather, it focused on grant application review responsibilities and related issues. Council unanimously approved this document and Dr. Levitin thanked the Council members for their assistance.

8. Public Comments

   There were no public comments.

9. Adjournment

   The 101st meeting of the National Advisory Council on Drug Abuse was adjourned at 1:00 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

Council Roster

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.