Minutes of the 96th Meeting of the National Advisory Council on Drug Abuse

May 15-16, 2007

The National Advisory Council on Drug Abuse convened its 96th meeting at 3:00 p.m. on May 15, 2007 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 May 15th, from 3:00 p.m. until 5:00 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 May 16th, from 8:30 a.m. until 12:00 p.m. The Council adjourned on May 16, 2007 at 12:00 p.m.

Council Members Present:

Louis E. Baxter, M.D.
Warren K. Bickel, Ph.D.
Steve Brasington, M.D. (Ex officio) 
Igor Grant, M.D.
Mark T. Greenberg, Ph.D.
Bankole A. Johnson, M.D., Ph.D.
Herbert D. Kleber, M.D.
Barry M. Lester, Ph.D.
Thomas E. Lucking, Ed.S.
Patricia I. Ordorica, M.D.
Daniele Piomelli, Ph.D.
Linda J. Porrino, Ph.D.
John P. Rice, Ph.D.
Mary Jane Rotheram-Borus, Ph.D.
Ellie E. Schoenbaum, M.D.
Marina E. Wolf, Ph.D.
Janet Wood, M.B.A., M.Ed.
Xiaoyan Zhang, Ph.D.

Council Members Absent:

Debra K. DePrato, M.D.

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:

Barbara Berman - MasiMax Resources, Inc.
Madelyn Blair - Pelerei, Inc.
Jack Blaine, M.D. - Contractor
Anne Bowen - MasiMax Resources, Inc.
Bryan Fantie - American University
Diane Galloway - Community Anti-Drug Coalition
Judy Galloway - Nat'l Association of Children of Alcoholics
Stacia Hall - American Academy of Child and Adolescent Psychiatry
W.B. Hamilton - Advantage Consulting, Inc.
Clare Imhultz - Substance Abuse Librarians and Information Specialists
Jennifer Isenberg - IQ Solutions
Andrew Kessler, Ph.D. - Friends of NIDA
Roxanne Kibben - Synergy Enterprises, Inc.
Marian Kratage - MasiMax Resources, Inc.
LouAnn Maier - MasiMax Resources, Inc.
Bob Morrison - Nat'l Assn of State Alcohol Drug Abuse Directors
Geoff Mumford, Ph.D. - American Psychological Association
Ramesh Nayak, Ph.D. - Contractor, Caspiansea, Inc.
Bobbie Peterson - RTI International
Pamela Pressley - Consortium of Social Science Associations
Anne Rhodes - VA Commonwealth University
Laura Rosenthal - Contractor
Mary Shilton - National Treatment Alternatives for Safe Communities
Taniesha Woods - Society for Research in Child Development

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 Office of Science Policy and Communications; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; the Division of Epidemiology, Services and Prevention Research; and the Division of Pharmacotherapies and Medical Consequences of Drug Abuse 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, 773 applications, requesting $773,079,843 in Total Years Direct Costs, went to review. Of these, 248 were scored by the Scientific Review Groups (SRGs) representing $50,085,301 in First Year Direct Costs and $207,183,665 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.

2. Consideration of the Minutes of Council

   The Minutes of the February 2007 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 that the 2007 Continuing Resolution provides a +0.1% increase from the prior year and that the 2008 President's Budget would yield the same increase. She noted funding trends for solicited and unsolicited applications and their success rates for NIH as a whole over several years, pointing to the large increase in submissions and the decline in success rates. The point was made that the proportion of solicited to unsolicited applications has not varied much over the years, nor is there evidence that those who respond to a solicited announcement have a better success rate. Rather, overall, the solicited have a slightly lower success rate. Turning to NIDA, Dr. Volkow described the importance of solicited announcements to the portfolio as well as the FY 2008 budget hearings, noting that there was a subject theme of mind, brain and behavioral research in the Senate hearings.

   She then described the process and outcome of the IC Directors' retreat that identified five topics and four strategic planning groups for Roadmap II. Dr. Volkow described some of the activities and the timeline for the epigenetics initiative, noting the importance of this area of science and also noting that epigenetic marks are altered in common brain disorders including addiction. The Directors of NIDA and NIEHS will co-chair the Roadmap II epigenetics initiative. Institutes will submit specific projects related to epigenetics and tools will also be developed.

   Dr. Volkow then turned to HIV/AIDS activities of the NIDA divisions and offices. She noted why she would be focusing on the HIV/AIDS portfolio and pointed out that about 30% of the NIDA budget is to be used for HIV/AIDS work and that the success rate for AIDS and non-AIDS research differs. Dr. Volkow explained NIDA's strategy for AIDS research, including infrastructure, innovative research and international activities, to ensure that the best science is submitted and supported. She noted that the funding cycle is such that in the next few years there will be a significant amount of AIDS money available for new projects. She noted that, therefore, it is extremely important to ensure that outstanding research applications are submitted and supported; to assist in this process brainstorming meetings both with the scientific community and with NIDA staff have taken place to identify the most important scientific areas, questions and approaches. These meetings led to the identification of significant new opportunities. Increasing access to existing cohorts, developing proteomic studies, and increasing international efforts--including connecting with extant infrastructures--are some of the directions meriting exploration. Also, NIDA will propose an award program similar to the NIH Director's Pioneer Award that will promote the work from the most creative of investigators. Dr. Volkow then provided examples of highly meritorious research that NIDA has supported in this important area of science. The Division of Epidemiology, Services and Prevention Research's (DESPR) support for work that identified the convergence of HIV seroprevalence among injecting and non-injecting drug users was highlighted, as was work that identified sexual and drug behavior patterns and HIV/STD racial disparities which was supported by the Division of Clinical Neuroscience and Behavioral Research (DCNBR). Dr. Volkow also reported on a Division of Basic Neuroscience and Behavioral Research (DBNBR)-supported study showing the effects of statins on the interactions of HIV-1-infected T cells with neurons with and without ETOH on the oxidative stress marker, heat shock protein 70. For the Center for Clinical Trials Network (CCTN), Dr. Volkow noted efforts to integrate HIV rapid testing and counseling into drug treatment. She pointed out that 1,000,000 people living in the USA are infected with HIV but that 25% of people with HIV are unaware that they are infected. Dr. Volkow highlighted the work of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) by reference to a study on injectable sustained-release naltrexone for opioid dependence treatment.

   Dr. Volkow described several FY 07 RFAs, noting the intent of the RFA, the mechanisms used, and the number of applications submitted in response to that RFA and, where appropriate, its relevance to HIV/AIDS. The RFAs presented included one on brain imaging and drug use prevention messages, another on extinction and pharmacotherapies for drug addiction, another on mechanisms of drug abuse interactions with HIV neuropathogenesis. An RFA on the development of immunotherapeutic products for the treatment of methamphetamine addiction as well as one on the design, synthesis and preclinical testing of potential treatment agents for drug addiction were also noted.

   Dr. Volkow described several recent and upcoming meetings, conferences and events. She noted that the very successful Addiction Project had garnered audiences on HBO channels, DVDs and podcasts; the estimated audience was over 50 million impressions and still counting. TV media coverage has included the Oprah Winfrey Show and Good Morning America, among others, yielding about 35 million viewers and presenting a clear message that addiction is a brain disease. Also, a Congressional Briefing sponsored by the Friends of NIDA addressed the blending of research and treatment. Further, changing NIDA's name to the National Institute of Diseases of Addiction is under consideration as is providing parity for the treatment of drug abuse. The American College of Neuropsychopharmacology organized a meeting to facilitate interaction between public and private parties to see how the pharmaceutical industry might become more active in partnering with the government in the development of medications. Also there will be a NIDA track at the American Psychiatric Association focused on translating of new insights into better psychiatric practice and many presentations will address comorbidity.

   Council members thanked Dr. Volkow for her presentation. Questions were raised about support for HepC research, possible reasons for higher risk for HIV in African-Americans, collaborations between NIDA and other Institutes as well as within NIDA, and the integration of behavioral research into the portfolio. There was also interest in epigenetic research as part of the NIH roadmap activity and the potential of epigenetic research was noted by several Council members and Dr. Volkow. The question was also raised about how Council could assist with Dashboard efforts. Council was invited to submit two or three ideas for Dashboard items that could become benchmarks for measuring NIDA programs. Dr. Condon noted that Dashboard items of interest include how new investigators fare in obtaining their first R01 award, how new investigators fare when they apply for their first renewal application, how clinical and preclinical investigators compare in terms of success, how more collaborations with other Institutes might be encouraged, and how training more new medicinal chemists might be encouraged. Council discussed the meaning and calculation of success rates and raised the question of how many preclinical and clinical/ Ph.D. and M.D. awardees of K grants receive additional grants. This information will be provided as will information about the proportion of applicants funded on their first try vs. on their first or second revisions. There was also discussion of what is acceptable to the Office of AIDS research as being HIV/AIDS research and of how well the diffusion of the AIDS portfolio across NIDA, rather than being concentrated in a single unit, is working. A question was raised about the success of the I/START and B/START programs, and Drs. Joseph Frascella and David Shurtleff said they were working well. Dr. Jacques Normand reported that NIDA has just initiated an HIV/AIDS-START program.

4. Update on the Intramural Program - Linda Porrino, Ph.D., Council Representative

   Dr. Linda Porrino provided an update on the intramural research program which included listing the staff who had recently been reviewed by the Board of Scientific Counselors and staff who would be reviewed in the near future. She also noted that the much anticipated move to the new facilities would be completed in 2007. Dr. Porrino provided information on extramural-intramural sharing of resources, noting that 18 intramural scientists have 145 collaborations with extramural scientists. She highlighted the work of two individuals as examples of this substantial collaborative activity and sharing of resources with the extramural community. Specifically, Dr. Porrino listed 20 collaborations of Dr. Marilyn Huestis and 28 collaborations of Dr. Amy Newman, describing the importance of these collaborations to the scientific community. She also noted that Dr. Marilyn Huestis had received the Irving Sunshine Award in 2007 from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. This award is presented no more than every two years to a scientist who has made outstanding contributions in the field of clinical toxicology. Also, Dr. Kenner Rice, who has recently joined the intramural program, received the Bristol-Meyers Squibb Smissman Award, an award presented every other year by the Division of Medicinal Chemistry of the American Chemical Society to a scientist whose research, teaching or service has had a substantial impact on the intellectual and theoretical development of the field of medicinal chemistry. Dr. Porrino concluded her presentation by presenting the 2007 initiatives. They include a viral gene delivery core, a mitochondrial diseases program, an obesity program and an ecological monitoring assessment (EMA) program.

   Council members thanked Dr. Porrino for her presentation and Dr. Barry Hoffer answered a question about conflicts of interest and allowable collaborations.

5. Data Sets of Interest to Drug Abuse Researchers - Wilson Compton, M.D., M.P.E., Director, Division of Epidemiology, Services and Prevention Research

   Dr. Compton began his presentation by providing an example of how secondary data can provide answers to important scientific questions. He then focused on epidemiology data sets, raising the question of what types of scientific opportunities these data sets provide and the question of how NIDA could promote the use of these resources, with the ultimate goal of enhancing the process of scientific discovery. The first examples presented were from cross-sectional data sets. One major data set is the Monitoring the Future, part of which is a repeated cross-sectional evaluation of students in the 8th, 10th and 12th grades every year since 1975. A group of scientists became interested in using this data set to understand smoking behavior and the impact of the Truth anti-smoking campaign. Both time series analyses and the distribution of media penetration of the campaign in different parts of the country could be used to begin to accumulate evidence about the effects of this campaign. Examination of the effects of this campaign was not an aim of the Monitoring the Future project, but secondary analysis allowed this important work to be done.

   A second major source of data often used for secondary data analysis is the household survey now called the National Survey on Drug Use and Health. Dr. Compton presented some of the work of Dr. Jim Anthony and his colleagues, who have been using the household survey for secondary analyses to identify, for example, neighborhood opportunities to buy drugs. They have discovered that the combination of delinquency and aggression led to about a five-fold increase in exposure to the opportunity to buy drugs. Dr. Compton also cited the work of Dr. Denise Kandel, who has used secondary data analyses to identify differences between African-Americans and whites in risk patterns for drug use. For example, she has discovered that in the youngest age group, smoking is much higher among White than African Americans, but there is also a cross over effect where, by their mid-twenties and later, there is an excess or an increase in the prevalence of smoking among African-Americans when compared with whites. Also, for African-Americans the onset of marijuana and cocaine use is later but the rate of dependence is slightly higher. Dr. Compton noted that these important findings need to be better understood.

   Another major set of household survey results comes from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC) study. This is a large household psychiatric epidemiology survey supported primarily by NIAAA, but also by NIDA. Dr. Carlos Blanco and his colleagues have used these data to look at prescription drug disorders, an area of substantial interest to NIDA, and have provided important public health findings from their secondary analyses. Dr. Compton noted that he had provided only a few examples of the many datasets that could be major resources for asking important questions. He listed several examples of national cross sectional data sets and select examples of other large data sets of interest, such as NIDA's Clinical Trials Network (CTN) data.

   Dr. Compton then turned to longitudinal studies, including the longitudinal part of Monitoring the Future (MTF). Every year some of the 12th graders are followed for additional data collection with the oldest subjects now in their mid-forties. In one study using this sample, it was found that, although there has been a reduction in smoking intensity across successive birth cohorts, smoking remains remarkably persistent across time among individuals themselves. Dr. Compton noted that this finding has implications for primary prevention programs. He then cited work in other areas--e.g., price elasticity in cocaine markets, family structure and dynamics--that has made use of the MTF data. He also noted work by Dr. William Crano, who is conducting analysis of the longitudinal National Survey of Parents and Youth to look at the predictors of risk and vulnerability to marijuana use onset. Dr. Compton then listed examples of nationally representative U.S. longitudinal data sets of interest as well as selected examples of other large data sets that are not national in their sampling but, nonetheless, would be useful for secondary data analyses.

   Dr. Compton then discussed some of the advantages and problems inherent in secondary data analyses. A major issue is access to data. Dr. Compton listed a relevant SAMHDA website and noted that NIDA is funding projects to improve the statistical methods that can be applied to these data sets and to serve as repositories for conducting secondary analyses. Confidentiality concerns must be taken into account, especially with longitudinal data sets. Also, scientists seeking to conduct secondary analyses may not have enough knowledge about the data sets of interest. There are often nuances in the data collection methods that are difficult to communicate, but through publications, seminars, and user groups, for example, knowledge about data sets can be shared. Dr. Compton then turned to the question of how we can improve the use of data. NIDA supports secondary data analysis from dissertation awards to large scale analyses and the development of new techniques. The Gene Environment Development Initiative (GEDI) is an example of using a very rich source of data and adding the possibility of collecting genetic information in conjunction with other types of information. Data sharing plans ensure that there will be access to the data. Another way to enrich the opportunities for people interested in drug abuse research is to develop common metrics for newly proposed studies, including those that are not primarily concerned with drug abuse/addiction but which might nonetheless include some appropriate measures of drug use and abuse. Dr. Compton pointed out that there is not consensus as to an appropriate list of measures for drug abuse. He concluded by noting that multiple rich sources of data exist and provide opportunities for developing and testing important hypotheses and that promoting the effective and efficient use of these data requires management and strategic planning.

   Council thanked Dr. Compton for his presentation and raised questions about combining data sets, about ways these data sets might benefit basic science, about the role of observation in determining research directions, about how NIDA might provide input into surveys and questionnaires to obtain more information about drug abuse and about the need to provide data relevant to state, county and local area concerns.

6. Update on the Clinical Trials Network - Betty Tai, Ph.D., Director, Clinical Trials Network

   Dr. Betty Tai noted that the five year vision of the Clinical Trials Network (CTN) has been to translate research into practice, to revive medical involvement in drug treatment and to use the CTN as a platform for additional research and training. The NIDA Clinical Trials Network is, today, a research infrastructure of 17 regional research training centers ( RRTCs) and 240 community-based treatment programs (CTPs) across 34 states and Puerto Rico, with a drug abuse treatment community that includes rehabilitation centers, hospitals, therapeutic community groups and methadone clinics, spanning social, behavior and medical models of treatment. Dr. Tai noted the number of trials that have been undertaken as well as those that are in earlier stages of development. To date, over 7,000 patients have been recruited into the various studies.

   She then summarized some of the pharmacological therapies protocols and gave an example of a pharmacological treatment study, the results of which indicate that buprenorphine/naloxone can be used safely and effectively for inpatient and out patient short term detoxification in community treatment settings and that more patients stay in care and complete the procedures with buprenorphine/naloxone. Dr. Tai also described several of the behavioral therapies studies and provided an example of a behavioral intervention involving motivational incentives/contingency management. The CTN has, with input from practitioners, enhanced the acceptability and sustainability in the community treatment programs of this type of intervention. Dr. Tai also presented results from studies on motivational incentives, noting, for example, that methadone patients reduce their use of cocaine and outpatients reduce their use of methamphetamines with motivational incentives.

   She then described the challenges of integrating drug abuse treatment into the mainstream of medical practice, noting the areas of psychiatric co-morbidity and chronic illness co-morbidity that would benefit from integrated care. It was clear from her presentation that there is an emerging public health crisis in the use of prescription opioid analgesics for non-medical purposes. Dr. Tai described how the CTN has responded promptly to this emerging crisis through the use of its existing infrastructure with a study on naloxone treatment of prescription opioid analgesic addiction. She also pointed to the importance of integrating onsite rapid HIV testing and counseling into drug treatment, citing a project that is identifying the most effective strategy to increase rates of HIV testing and communication of results. This project also will identify what testing strategy is most effective in reducing risk behaviors.

   Dr. Tai presented information on the blending initiative, a SAMHSA-NIDA collaboration through the ATTCs. A variety of blending products were described, and Dr Tai also provided an example of how new supervisory tools for enhancing proficiency with Motivational Interviewing assessment were developed and disseminated through the SAMHSA ATTCs. Within the CTN, candidates from 15 CTN nodes participated in a special Motivational Interviewing training program that will develop a network of competent Motivational Interviewing counselors and of a cadre of on-site supervisors for the CTPs. The CTN dissemination library, data sharing activity and the CTN platform and training network were also described, demonstrating the range of CTN activities.

   Dr. Tai concluded by noting that research and practice can be bridged. Researchers and practitioners can collaborate productively. Community drug treatment can benefit from CTN research. Treatment research can benefit from the CTPs' involvement and the CTPs can recruit patients and conduct quality RTCs successfully. Further the CTPs can also become interested in research and independently secure research funding, as has been demonstrated by the Oregon/Hawaii node, for example. Dr. Tai also noted that a NIH Roadmap initiative included an inventory of clinical research networks. Of the 267 networks that qualified, the NIDA CTN was one of 29 selected for further study and was recognized for its best practices in a number of areas, including establishing trust and respect between researchers and practitioners. Dr. Tai concluded her update by acknowledging the dedication of the CCTN staff. Council thanked Dr. Tai for her presentation and asked about whether the networks collected samples that would be suitable for genetics studies, about combining behavioral therapy and pharmacotherapy for optimal outcomes, about the CTN success in bringing researchers and practitioners together to learn from each other, and about projections for the stability and growth of the CTN, and about CTN success in translating findings from the clinic to the community.

7. Public Comments

   Dr. Andrew Kessler spoke on behalf of the Friends of NIDA. He described the coalition of associations and individuals that comprise the Friends of NIDA and noted some of their recent activities. He noted that the next Congressional briefing would be on co-morbidity and he welcomed Council questions about this organization.

8. Adjournment

   The 96th meeting of the National Advisory Council on Drug Abuse was adjourned at l2:00 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.