107th Meeting Minutes

February 2, 2011

The National Advisory Council on Drug Abuse convened its 107th meeting at 8:30 a.m. on February 2, 2011 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director, NIDA, chaired the meeting. The closed portion of the meeting on February 2, 2011, from 8:30 a.m. until 10:30 a.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, on February 2, 2011, was from 10:30 a.m. until 2:30 p.m. The Council adjourned on February 2, 2011 at 2:50 p.m.

Council Members Present:
Louis E. Baxter, M.D.
Francisco X. Castellanos, M.D.
Steven R. Childers, Ph.D.
Thomas J. Crowley, M.D.
Anita S. Everett, M.D.
Caryn E. Lerman, Ph.D.
Daniele Piomelli, Ph.D.
Mary Jane Rotheram-Borus, Ph.D.
James L. Sorensen, Ph.D.
Hazel H. Szeto, Ph.D., M.D.
R. Dale Walker, M.D.
Steven M. Wolinsky, M.D.
Jon-Kar Zubieta, M.D.

Council Members Absent:
Ex Officio: John P. Allen, Ph.D., M.P.A.
Eric Nestler, Ph.D., M.D.

Council Chair:
Nora D. Volkow, M.D.

Executive Secretary:
Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:
Sue Camaione - RTI International
William Corrigall, Ph.D. - Contractor
Yoshie Davison, M.S.W. - American Academy of Child and Adolescent Psychiatry
Jason Ezzelle - PPD., Inc.
Julie Miller, Ph.D. - RTI
Pat President, M.L.S. - CSR, Inc.
Patrick Zickler - SEI Services, Inc

Closed Portion of the Meeting - February 2, 2011

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. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. She 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 Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; the Division of Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse; and the Office of Science Policy and Communications; presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Council also approved all administrative supplement requests and a MERIT application.

   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.

Open Portion of the Meeting - February 2, 2011

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order. 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 10-11, 2011 (later changed to May 11, 2011), September 13-14, 2011; February 14-15, 2012, May 8-9, 2012, September 5-6, 2012.

2. Consideration of the Minutes of Council

   The Minutes of the September 2010 meeting were approved as written.

3. Operational Procedures and Statement of Understanding - Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, NIDA and Executive Secretary, National Advisory Council on Drug Abuse

   Dr. Levitin noted the NIH policy that each institute and its advisory council develop a document outlining the operating procedures and delegation of authority relevant for grant review responsibilities of that council and institute staff. This document needs to be approved on a yearly basis and NIDA Council traditionally reviews the document at its February meeting. This document is also made available to the Office of Extramural Research of the NIH for its review to ensure compliance with relevant NIH policy.

   Dr. Levitin noted that the document approved in 2010 had been sent to Council prior to the meeting, along with a request for feedback. No suggestions were received. Dr. Levitin then reviewed the document with Council to see if there might be any recommendations now. She highlighted each of the sections of the document, for example, the use of en bloc concurrence, approval of administrative supplements, and other matters. She explained which matters require Council action and which are the responsibility of NIDA staff, and she also assured Council members that any unusual matters, even if delegated to staff for action, would be brought to Council for their information.

   Council unanimously voted to approve the document.

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

   Dr. Volkow began her report with a review of the budget, noting that NIH was still on a Continuing Resolution and that the 2011 President's Budget would provide NIDA with a total budget of $ 1,094,078, a 3.3% increase over the prior year. She then turned to new NIH activities, describing the NIH Board of Scientific Advisors' recommendation that NIH should establish a new entity devoted to advancing translational medicine and accelerating therapeutics development. This new entity would incorporate many existing programs such as the molecular libraries, CTSAs, CAN, and NIH-FDA partnerships, as well as other existing components or new resources to be developed, as appropriate. The range of activity would be from disease target to clinical trials. Dr. Volkow also reported on the status of the proposed new institute on substance use, abuse and addiction research. The most recent activities have been the December town hall meeting convened by Dr. Collins for the staffs of NIAAA and NIDA and the meetings taking place with the task force and representatives of NIDA, NIAAA, NCI, NIDDK, NICHD, and NIMH to collect information to inform the process of creation of a new institute rather than a merger of only NIAAA and NIDA portfolios.

   Recent NIDA activities and events have included several staff changes, including the appointment of Dr. David Shurtleff as Acting Deputy Director of NIDA and Dr. Amy Newman as Deputy Scientific Director of the NIDA IRP. Dr. Joni Rutter will be the Acting Director of DBNBR and Dr. Susan Weiss will be the Acting Deputy Director, OSPC. Dr. Gaya Dowling will be the Acting Chief of the Science Policy Branch of OSPC. Dr. Yavin Shaham will be the Chief of the Behavioral Neuroscience Branch at the IRP and Dr. Toni Shippenberg will be the Chief of the Integrative Neuroscience Research Branch at the IRP.

   Dr. Volkow summarized recent ARRA funded projects, highlighting a Phase III study of a nicotine vaccine for smoking cessation that now has two active 1,000 subject Phase II studies in progress. She also presented a six-month RCT of probuphine in opioid addiction which now has an ongoing Phase III multi-site clinical trial of an implantable formulation of buprenorphine, i.e. Probuphine. Results of this study should support the NDA approval for Probuphine. Another ARRA project is an adenovirus-based anti-cocaine vaccine that leverages an adenovirus (Ad) gene transfer vector and retains many of the immunogenic adjuvant-like properties of the live Ad vector. The final ARRA example was that of a project on HIV rapid testing and counseling in STD clinics which is an adaptation of the CTN 0032 Project Aware study; this is a randomized controlled multi-center HIV project that will evaluate the effects of rapid HIV testing, with and without counseling, on the acceptance of testing and reduction of risky behaviors.

   Dr. Volkow reminded Council of NIDA's priority areas of prevention research with children and adolescents, treatment interventions, and medical consequences-HIV/AIDs. She presented results of studies in each of these priority areas. In the prevention area, she summarized some findings from the University of Michigan's 2010 Monitoring the Future Study and identified relevant new PAs and RFAs, including a PA on the development of frontal cortex and limbic system and their roles in drug abuse.

   In the area of treatment interventions, Dr. Volkow listed several potential targets for medication development. She also described the work and the membership of the medications development scientific workgroup which met in January and provided several recommendations, including trimming and focusing the medications development portfolio and developing a target product profile for every compound in development. Another recommendation was to focus on preparing to market potential medications to a commercial partner capable of sustaining development through late-stage clinical trials and commercialization, i.e., providing proof of concept and proof of pharmacological mechanism. Several new PAs and RFAs were presented.

   In the area of HIV and drugs, Dr. Volkow described the "seek, test, treat and retain" RFA that will address HIV among vulnerable populations. She presented questions and recommendations derived from a meeting on the genomics and epigenomics of HIV/AIDS and substance abuse. These included asking what the most critical research questions are for genomics research in HIV/AIDS and substance abuse and identifying meaningful and useful substance use assessment tools to incorporate into ongoing clinical HIV studies. Also encouraged was collaborative research addressing clinically relevant questions on genetic and epigenetic factors associated with HIV latency, innate immune responses, variability in disease outcomes and the impact of substance use on these associations. Upcoming activities include the AIDS Avant-Garde review; next year foreign scientists will be able to apply to this program. New PAs and RFAs were also presented as were the major conclusions from a meeting on prescription opioids and pain. In collaboration with the NIH pain consortium, a medical/dental/nursing students' pain education workshop was held. A proposed organization of NIH pain consortium centers of excellence was also presented and the program for developing a curriculum on pain was described.

   Dr. Volkow presented announcements from OppNet and the NIH Blueprint for neuroscience research, noting that they provided opportunities in several different areas of science and training. She then described several activities centered on the November 8-14 National Drug Facts Week. Activities included working with federal and private sector partners to encourage events in communities, producing a teen booklet, "Shatter the Myths," and partnering with the MusiCares/Grammy Foundation to launch a music video contest. Council members viewed a short video clip of the first place teenage winner of this contest. Dr. Volkow concluded her presentation by describing several new collaborations between NIDA and other agencies, both within and outside of NIH.

   Council thanked Dr. Volkow for her report. Council then discussed issues concerning the creation of the proposed new institute on substance use, abuse and addiction research, including concerns about possible decreases in funding, questions about how comorbidity and several areas of science might fit into the new institute, and ways of thinking about different scientific areas. It was noted that Council members had insights and expertise ranging from clinical and basic areas of research that would be relevant and that Council wanted to be of assistance in sharing that expertise with those at NIH working on creating this new institute. Thus, it was decided to send a letter from the Council expressing interest in providing their expertise. There was also discussion about the utility of meeting with the NIAAA Council.

5. Drug Abuse Research in Criminal Justice Settings: Improving Public Health & Safety - Redonna Chandler, Ph.D., Chief, Services Research Branch, Division of Epidemiology, Services and Prevention Research (DESPR)

   Dr. Chandler began her presentation by noting that she would provide reasons NIDA works with the criminal justice system, the public health problems of those in the criminal justice system, relevant research and dissemination efforts, and future plans for work in this domain. She then pointed out that drugs of abuse and crime are linked, citing a number of statistics such as drug use at the time of offense to demonstrate the importance of a focus on the criminal justice system. She noted that drug-related crime costs approximately $107 billion dollars a year and that, since 2005, the combined federal, state and local adult correctional population has been over 7 million people, with the United States imprisoning more people per capita than any other country in the world, having a 239% growth in the 1990s of the prison population.

   Dr. Chandler than presented the racial distribution in the correctional system, noting, for example, that African-American citizens are about 11% of the United States population, but make up 43% of the imprisoned population. She also presented information on alcohol use disorders and drug use disorders, noting the increased estimates of the population affected by alcohol and drug use disorders. She indicated the estimated size of the correctional population with drug use disorders, including both adult and juveniles, and pointed out that rates of smoking are four times higher in the criminal justice population than in the general population. Further, mental health disorders among incarcerated populations are far higher than among the general population, and incarcerated populations have a variety of medical problems, as well. Dr. Chandler stated that treatment planning for drug-abusing offenders should include strategies for chronic medical conditions such as HIV/AIDS, Hep B/C and TB. She noted that although many prison inmates have a drug use disorder, very few receive treatment in either federal or state prisons. For example, in any given year, over 200,000 heroin addicts pass through prison, but less than 1% receives methadone treatment.

   She delineated two approaches to addressing drugs and crime: 1) the public health approach which focuses on disease and treatment and is characterized by high attrition, and 2) the public safety approach with focuses on illegal behavior and punishment and is characterized by high recidivism. Dr. Chandler then noted that an integrated public health/public safety strategy blends the functions of criminal justice and treatment systems to optimize outcomes and that this strategy is effective. She described how drug abuse can be addressed, from entry into the correctional system through several steps and finally community reentry, and who the key players are at each point in the process in order to clarify the complexity of the various steps and functions and the distinctive parts of the system.

   Dr. Chandler then turned to an overview of the NIDA criminal justice portfolio, noting that there are projects being supported in basic science, basic neuroscience, treatment development and service delivery, prevention, epidemiology as well as medication development and implementation, for a total of 119 projects. She described the CJ DATS program, which has 12 research and academic institutions throughout the country that are partnered with different criminal justice settings and have collaborated on a variety of projects. Currently the focus is on intervening at the systems level. She provided information about the implementation of a continuum of care for those with HIV or at risk of infection, implementation in correctional settings of medication-assisted treatment for addictions, and implementation of screening and assessment tools for drug abuse and addiction. Dr. Chandler also described recent RFAs that call for a seek, test and treat research program to address HIV in the criminal justice system, noting that 12 research centers and criminal justice agencies are involved in this program. Several dissemination activities were then described. These include judicial training of judges, consulting with the Bureau of Justice, and collaboration with the Federal Bureau of Prisons.

   Dr. Chandler concluded her presentation by pointing to the three future directions for this important program: 1) harmonization of the work of the seek, test, and treat grantees; 2) prevention and treatment development for adolescents in juvenile justice; and 3) implementation of research facilitating uptake of EB prevention and treatment practices in juvenile justice.

   Council thanked Dr. Chandler for her presentation. It was noted that it is important to distinguish between those who have a drug abuse problem and those involved in a drug-related offense, and that the number of people who develop a drug abuse problem after incarceration is unknown. Finally, in response to a question, Dr. Chandler stated that NIDA has the largest portfolio at NIH of research on individuals in the criminal justice system.

6. Common Data Elements and the Electronic Health Record: From SUD Treatment Research to Patients' Health - Betty Tai, Ph.D., Director, Center for Clinical Trials Network (CTN)

   Dr. Tai began her presentation by defining electronic medical (health) records (EM(H)R), noting that EMR and EHR contain the same data elements but vary as to who owns the information and where it is stored. She pointed to some of the potentially positive effects of EMHR on patient care, including improved care quality, reduced costs and integrated care as well as provision of a framework for clinical decision support and aiding guideline implementation. Dr. Tai then explained the federal mandate for the adoption of EMR, pointing out relevant definitions and requirements, as well as the financial incentives available to promote the adoption by meaningful use of certified EMHRs offered by ONC, and other factors. She further stated that all medical records must be digitized by 2015 for CMS reimbursement.ity, and the role of the VA and Indian Health Services in this process.

   Dr. Tai then described the EMR landscape in the United States for SUD treatment programs, and she noted that interoperability is a critical issue. For example, she referenced a recent pilot sample study which revealed that no substance use treatment agency has the capability to communicate electronically across programs. She further noted that multiple vendors are developing EMR for hospital-based systems and individual medical practice-based systems, and she pointed to the need to have substance use disorders integrated into these systems. The key to this integration is to identify the data elements core to substance abuse treatment and to standardize these data elements for interoperability to facilitate the incorporation into all developing EMRs for both clinical care and research needs.ity, and the role of the VA and Indian Health Services in this process.

   The NIDA CTN EMR efforts have accomplished the following tasks: Formed a CTN special interests group as the brain trust for NIDA EMR efforts; sixty-seven CTN affiliated providers have responded to the request for submission of their medical records forms and templates; ten sets of records have been selected that exemplify core data elements in substance use disorders.ity, and the role of the VA and Indian Health Services in this process.

   Dr. Tai then presented an overview of the SUD EMR development process to date, including drafting SUD domains, sub-domains and questions, obtaining stakeholder input and consensus, creating a draft consensus document and distributing the document for review and feedback. She described some of the constraints and considerations for EMR development. She noted that the current effort is to develop an EMR core or minimal data set for SUD, which could be expanded as required. The importance of developing these elements with interoperability and certified EHR technology in mind was stressed. She illustrated SUD sub-domains and domains and further illustrated the types of questions and information that would be gathered under the domain/sub domain of addiction history and status. She demonstrated that NIDA's proposed SUD EMHR would have a small core set of screening questions to be used in a primary care or other medical settings and an enlarged core set of questions for an SUD specialty treatment setting.ity, and the role of the VA and Indian Health Services in this process.

   Dr. Tai discussed a pathway to interoperability, by applying a biomedical research integrated domain (BRIDG) model CDEs. Dr. Tai then turned to the challenges faced while creating common data elements, presented a substance abuse EMHR mind map, and provided more information about implementation of the EMR initiative. She noted the benefit of deriving data from a single source that could have multiple uses, including patient care, research and reimbursement, quality improvement, post marketing safety, decision support, administration and management and population health reporting, etc. She then illustrated the overlap of data used for many purposes and stressed the importance of meeting the challenge to develop common data elements to enable interoperability. Dr. Tai then presented highlights of NIH efforts from multiple ICs in developing CDEs for research and patient care. She concluded by pointing out how EHR will advance research as well as patient care and how the development of an EM(H)R in SUD will have profound and far reaching ramifications for patient care and research in the substance use disorders field.ity, and the role of the VA and Indian Health Services in this process.

   Council thanked Dr. Tai for her presentation. Questions were raised about 42 CFR, about the DSM process and interoperability, and the role of the VA and Indian Health Services in this process.

7. Data Harmonization in NIDA-Funded Clinical Research - Kevin Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, And Prevention Research (DESPR)

   Dr. Conway opened his presentation by stating that he had three goals: 1) providing an overview of NIDA's vision for data harmonization, 2) alerting NIDA staff about this project, and 3) recruiting experts on Council to participate or to nominate participants. Dr. Conway then defined harmonization, noting that it means having commensurate measurement across independent studies such that 1) constructs have the same theoretical meaning, 2) measures reflect the same construct, 3) variables are scored with identical values, and 4) values are scaled commensurately and function equivalently.

   He illustrated degrees of harmonization by examples from nicotine dependence research, pointing out that the construct level, measure level and item level must be taken into account. He then presented and explained three different cases of harmony. The first was complete harmony among construct, measure, and item levels. The second case was that of construct level harmony, and the third was that of construct, measure, and partial item level harmony. Dr. Conway also presented an empirical demonstration of what can happen with pooled data analysis among different studies, all using the concept of internalizing symptomatology and various items across two different instruments to measure that concept.

   Dr. Conway next turned to the NIDA harmonization project, noting that harmonizing is a way to increase cross-study comparability, collaboration, and scientific yield through the use of multi-site pooling for integrative data analysis, cross-site replication/comparisons, meta analyses and secondary analyses. Specifically, NIDA intends to create and implement a plan that achieves maximum harmonization and uptake by investigators through adapting the PhenX Toolkit to ensure that it meets NIDA's needs.

   Dr. Conway then described the PhenX toolkit. It is a three year project funded by the National Human Genome Research Institute to contribute to the integration of genetics and epidemiologic research. Consensus building is being used to develop a recommended minimal set of high priority measures for use in large scale research studies. Dr. Conway walked Council through the toolkit, highlighting the measures available for the study of alcohol, tobacco, and other substances. He also showed Council a protocol overview for nicotine dependence and the specific questions that could be used.

   The NIDA harmonization project is characterized by a multilevel approach with cores to maximize gain while minimizing cost, risk, and time to payoff. This approach also harmonizes data whether already collected or yet-to-be-collected and builds upon the existing PhenX infrastructure and promotes construct quantification through integrative data analysis. Dr. Conway explained the project organization, including the central core questions asked in every study, with specialty core questions based on the specific interests of the study. Thus, a genetics of nicotine study would use three cores: central, genetics and nicotine. The project timeline was then presented, and Dr. Conway noted that the schedule is a very tight one; an advisory committee and work groups need to be established or continued, and a number of tasks need to be done expeditiously. It is hoped that Council will help identify people who could serve on various relevant workgroups. Dr. Conway closed by acknowledging NIDA staff on the NIDA harmonization working group as well as other participants and listing an NIH Guide Notice about a supplemental program for the PhenX toolkit.

   Council thanked Dr. Conway for his presentation. Questions were raised about back-translations of items, the availability of the PhenX toolkit to anyone who is interested, the inclusion of children in the PhenX toolkit data base, the importance of encouraging but not mandating the use of the toolkit, and how future investigators might make the best use of the toolkit in conjunction with their own measures, using both a shared core and individually tailored items.

8. Public Comments

   There were no public comments.

9. Adjournment

   The 107th meeting of the National Advisory Council on Drug Abuse was adjourned at 2:30 p.m.

Certification

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

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