Minutes of the 84th Meeting of the National Advisory Council on Drug Abuse

May 21-22, 2003

The National Advisory Council on Drug Abuse convened its 84th meeting at 1:00 p.m. on May 21, 2003 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director, NIDA, chaired the overall meeting, and Mr. Richard A. Millstein, Deputy Director, NIDA, chaired the closed session and the application reviews. The meeting on May 21 was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The meeting reconvened on May 22 at 9:00 a.m. and was open to the public. The Council adjourned May 22 at 2:30 p.m.

Council Members Present:

Rodolfo Arredondo, Ed.D.
Dorothy K. Hatsukami, Ph.D.
Kenneth J. Hoffman, M.D., M.P.H. (ex officio)
Peter W. Kalivas, Ph.D.
A. Thomas McLellan, Ph.D.
Scott A. Reines, M.D., Ph.D.
David L. Rosenbloom, Ph.D.
James E. Smith, Ph.D.
Claire E. Sterk, Ph.D. 
Jose Szapocznik, Ph.D.
David Vlahov, Ph.D.
Constance M. Weisner, Dr.P.H.
Robert L. Woodson, Sr., M.S.W.
Nancy R. Zahniser, Ph.D.

Council Members Absent:

Norman B. Anderson, Ph.D.
Steven C. Hayes, Ph.D.
Robert C. Malenka, M.D., Ph.D.
Peggy B. Sapp

Council Chairs Present:

Nora D. Volkow, M.D.
Richard A. Millstein, J.D.

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

National Institute on Drug Abuse, NIH, DHHS

Other Federal Employees Present:

Duane F. Alexander, Ph.D. - National Institute of Child Health and Human Development
Elizabeth A. Davis - National Institute of Child Health and Human Development
Della Hann, Ph.D. - Office of Extramural Research, OD, NIH
Ranga V. Srinivas, Ph.D. - Center for Scientific Review, NIH
Luci Roberts, Ph.D. - Center for Scientific Review, NIH

Members of the Public Present:

Sue Camaione - MasiMax Resources
Duncan Clark - University of Pittsburgh
Joseph Carey - Society for Neuroscience
Michael Dennis, Ph.D. - Chestnut Health Systems, Illinois
Marie Dyak - Entertainment Industry Council
Nabila El-Bassel, Ph.D. - Columbia University, New York
Cindy Elliott - MasiMax Resources
Gary Field, Ph.D. - Oregon Department of Corrections
Glen Fischer - Management Assistance Corporation
J. Gartenmann - American Society of Addiction Medicine
Mary Beth Hatem - MasiMax Resources
Jocelyn Kaiser - Science Magazine
Lee Herring - American Sociological Association
Mary Kratage - MasiMax Resources
Sherry Marts, Ph.D. - Society for Women's Health Research
Bill Northey - American Association for Marriage and Family Therapy
Martha Pien - MasiMax Resources
Sam Schildhaus - National Opinion Research Center, University of Chicago
S. Sepelak - Social and Scientific Systems
Mary Shilton - National Consortium of TASC Programs
Mickey J.W. Smith - National Association of Social Workers
Edward Spitznagel, Ph.D. - Washington University
Daniel Tisch - MasiMax Resources
Robert Trachtenberg - Contractor
Diedre Watkins - MasiMax Resources
Kim Zink - IQ Solutions
J.L. Zlotnik, Ph.D. - 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).

   Mr. Richard A. Millstein, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. He 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 the meeting was closed to the public. Dr. Teresa Levitin, Executive Secretary, summarized voting policies and procedures, 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 Treatment Research and Development; the Division of Epidemiology, Services and Prevention Research; the Division of Neuroscience and Behavioral Research; the Center on AIDS and Other Medical Consequences of Drug Abuse; and the Center for Clinical Trials Network presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Requests for three MERIT awards and 15 administrative supplements were also reviewed and approved.

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

   For this Council, 701 applications, requesting $657,638,176 in Total Years Direct Costs, went to review. Of these, 466 were scored by the Scientific Review Groups (SRGs), representing $101,636,516 in First Year Direct Costs and $450,207,794 in Total Years Direct Costs. Council concurred with the SRGs in time and amount. The Council approved three MERIT awards.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members, NIDA staff, and visitors. She noted that four Council members were unable to attend. Dr. Volkow thanked Dr. Glen Hanson for an outstanding job serving as Acting Director, NIDA, from December 2001 through April 2003. 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.

2. Consideration of the Minutes of Council

   The Minutes of the February 12-13, 2003 meeting were approved as written.

3. NIDA Director's Report

   Dr. Volkow welcomed new staff members and reported on other recent changes at NIDA. She gave an overview of her background prior to coming to NIDA, noting that she has been doing addiction research for 20 years. Her expertise is on the neurobiology of addiction, and she is particularly known for her work investigating the mechanisms underlying the reinforcing, addictive and toxic properties of drugs of abuse in the human brain. Dr. Volkow received her M.D. from the National University of Mexico and completed her residency in Psychiatry at New York University. She served as Associate Director for Life Sciences, Chairman of the Medical Department, Director of Nuclear Medicine, and Director of the NIDA-DOE Regional Neuroimaging Center at the Brookhaven National Laboratory. She also served as Professor in the Department of Psychiatry and Associate Dean for the Medical School at SUNY-Stony Brook.

   Research areas she would particularly like NIDA to address include the impact of genetic and environmental influences in the vulnerability to addiction, prevention research in children and adolescents, and treatment interventions.

   Dr. Volkow reported on the NIH Roadmap activity, in which NIH Institute Directors and extramural experts met several times to identify trans-NIH initiatives unique to NIH and its mission. Using new approaches and new technologies, such as regenerative medicine, molecular imaging, nanotechnology and molecular libraries; creating multidisciplinary research teams of the future; and re-engineering the clinical research enterprise were among the initiatives identified. She noted that molecular libraries are crucial for medication development.

   Budget

   Dr. Volkow reported that the NIDA budget for FY 2003 increased 8.6% over the FY 2002 appropriation and the FY 2004 President's proposed budget has an estimated 3.7% increase over the FY 2003 appropriation.

   Recent NIDA Activities

   Dr. Volkow highlighted several meetings of interest. To commemorate Brain Awareness Week at NIH, a symposium entitled Stress and the Brain: Developmental, Neurobiological and Clinical Implications was held in March 2003. This meeting addressed basic and clinical scientific findings related to the various ways stress can impact the brain. NIDA also hosted a two-day symposium, "Foundations and Innovations in the Neuroscience of Addiction," in May 2003 to honor the late Dr. Roger Brown and his great contributions to the neuroscience program at NIDA. Another meeting entitled "Beyond the Clinic Walls: Expanding Mental Health, Drug and Alcohol Services Research Outside the Specialty Care System" was co-sponsored by NIDA, the National Institute of Mental Health, and the National Institute on Alcohol Abuse and Alcoholism. Over 250 participants attended this multi-institute services research conference, the first ever held at NIH. This meeting represented a new commitment to collaborative efforts among the three institutes to strengthen the research base underlying care for people with addictions and mental health problems. NIDA also sponsored a workshop on model systems for neuroproteomics in March. Another NIDA-sponsored conference entitled "What Do Schools Really Think About Prevention Research? Blending Research and Reality" provided a forum for discussing the challenges in conducting prevention research and implementing research-based prevention programs in schools. Other recent meetings were also highlighted.

   Dr. Volkow reported that the 7th Annual PRISM Awards were held on May 8, 2003. This event, co-sponsored with the Robert Wood Johnson Foundation and the Entertainment Industries Council, honors creative contributions that accurately portray substance abuse and addiction. A new category was added this year that recognizes individual performances in feature films, television series and made-for-TV movies.

   Dr. Volkow called attention to several Program Announcements (PAs) in which NIDA has collaborated with other Institutes. One PA will organize programs for international clinical, operational and health services research training for AIDS, tuberculosis, and related conditions in resource-limited nations. Another collaborative PA will invite applications for core grants to support centers for AIDS research, and another will focus on gene discovery for complex neurological and neurobehavioral disorders research. A recently released Request for Applications (RFAs) with other NIH components involved clinical research education and career development in minority institutions.

   Dr. Volkow noted that collaborative work between NIDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) is significant in translating research findings into relevant clinical practice. These science-to-services efforts include providing NIH grant writing technical assistance. CSAT and CSAP, respectively, co-fund the NIDA's criminal justice initiative and multi-site community prevention trials, and NIDA provides support for some SAMHSA activities.

   Dr. Volkow has met with each of the NIDA divisions for an overview of proposed division activities for 2004 and beyond. The Division of Neuroscience and Behavioral Research presented a 5-year plan that will expand the ability to support transdisciplinary research approaches; take advantage of new technologies, models and paradigms; and look at genetics and vulnerability and the developmental processes. New initiatives by the Division would foster research in tobacco addiction, proteomics, adolescents and drug abuse, and drug abuse relapse. The Division of Treatment Research and Development reported that its 5-year plan includes a shift in medications development efforts from opiates to stimulants and nicotine, and efforts to strengthen relationships with the pharmaceutical industry. The Division plans to revive medical involvement in drug abuse treatment and consider new directions for behavioral therapy development. New initiatives will focus on neurodevelopment and pediatric neuroimaging, integration of HIV and infection disease risk reduction interventions into behavioral treatments, translational brain imaging centers, and access to chemical and molecular libraries. The Division of Epidemiology, Prevention and Services Research's 5-year plan includes environment-gene interaction studies, service systems studies for prevention and treatment to improve public health outcomes, and applying concepts and methodologies from allied fields to "real world settings" public health research. The Division's new initiatives will foster research in novel approaches to phenotyping drug abuse, prevention and treatment of drug abuse in primary care settings, prevention programs aimed at young adults, and family-based prevention systems. The Center on AIDS and Other Medical Consequences of Drug Abuse presented plans to advance HIV/drug use epidemiology and prevention studies, tailor HIV treatment for drug abusers, and focus on drug and drug interactions. The Center's new initiatives will foster research on hepatitis C, the longitudinal effects of drug use in children, women's health research, and HIV/AIDS prevention and drug abuse treatment in the Caribbean and China. The Center for the Clinical Trials Network reported that its 5-year plan includes refinement of the CTN's infrastructure and mission, development of clinical practice guidelines, reviving medical involvement in drug abuse treatment, and enhancing the CTN as a platform for additional types of research and as an infrastructure for training.

   Dr. Volkow concluded by describing the Blue Ribbon Task Force, a Council work group to look at the NIDA services research program. She noted that she would also like Council to help assess the Clinical Trials Network and the HIV/AIDS programs.

4. NICHD and the National Children's Study - Dr. Duane Alexander

   Dr. Volkow introduced Dr. Duane Alexander, Director of the National Institute of Child Health and Human Development (NICHD). Dr. Alexander reported on the National Children's Study, a longitudinal study of environmental effects on child health and development. He commented that Congress directed NICHD to plan the National Children's Study, and it was done in collaboration with the Centers for Disease Control and Prevention, the National Institute of Environmental Health Sciences, and the Environmental Protection Agency. Children have an increased vulnerability to environmental exposures (air, water, food and other environmental exposures) due to their metabolism and behavior. Known exposures of concern come from many sources. He added that all of these have an impact on development, but the extent is unknown. Dr. Alexander noted that important childhood conditions such as birth defects, autism, cerebral palsy, asthma, type I diabetes, schizophrenia, obesity, and cancer have suspected environmental components.

   The Children's Health Act of 2000 directed NICHD to establish a consortium of representatives from appropriate Federal agencies to conduct a national longitudinal study of environmental influences on children's health and development. The study would be a longitudinal study of children, their families and their environment; be national in scope; define environment as chemical, physical, behavioral, social, and cultural; be of sufficient size (approximately 100,000 participants); and look at gene/environment interactions. He added that the study would use state-of-the-art technology, be a consortium of multiple agencies, be hypothesis driven, and be a national resource for future studies. Dr. Alexander noted that some of the priority outcome areas of the study include undesirable outcomes of pregnancy, neurobehavioral development, injury, asthma, and obesity and physical development. He explained that one of the hypotheses under consideration that specifically dealt with drug abuse was how prenatal exposure to drugs would interact with family, child and other factors to influence cognitive, social/emotional and physical development.

   Dr. Alexander reported the central hypotheses and design study should be finished this year. In 2004 NCS study sites will be selected across the U.S. Participant recruitment is projected to begin in 2005 with targeted hypotheses-testing analyses starting at that time. Funding will be made available from NIH and other organizations for investigator-initiated research and analyses. The first research results should be available in 2008. He added that from years 2008-2030 the results would translate into disease prevention strategies.

   Dr. Alexander noted that an interagency coordinating committee from NICHD, the NIH National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, and the Environmental Protection Agency provides leadership and funding, and the NICHD will manage operations for the study. There is a Federal consortium of all the Department of Health and Human Services agencies plus 12 other departments and independent agencies, and a chartered Federal Advisory Committee provides advice and peer review. In addition 20 working groups consisting of approximately 250 scientists and experts will provide consultation and guidance on the hypotheses, design, and measures of the study.

   Dr. Alexander concluded that the National Children's Study would provide the answers to concerns about known exposures to potential toxicants during childhood, identify early life factors contributing to many adult conditions, determine causal factors for a number of diseases of children with suspected environmental causes, and be a national resource to answer future questions.

5. Report on Administrative Supplements - Mr. Richard Millstein

   Mr. Millstein gave an overview of NIDA research grant supplements. He noted that occasionally investigators need additional funds to supplement their approved budgets. NIDA uses two types of supplements, competitive and administrative, to accomplish this. A competitive supplement is initiated by the applicant submitting a PHS 398 for peer review. Mr. Millstein added that competitive supplements are used to request an expansion of a project's approved scope of work; however, the work is closely tied to the parent grant. Administrative supplements are applicant-initiated and are submitted for internal review. These requests are for additional funding for unforeseen increased costs within the scope of the approved application, such as salary increases, loss of equipment, errors in recommendations or awards, orderly termination, or for bridge funding. He explained that NIH allows use of administrative supplements to achieve special purposes, such as grant support for research by underrepresented minorities and individuals with disabilities, or for re-entry into biomedical and behavioral research careers. NIDA uses the administrative supplement for the same purposes as the NIH-wide program and also for ongoing programs and one-time applications. Mr. Millstein added that Council's role involves considering the competitive supplements along with competing grant applications, and advising on and approving administrative supplements. Council has delegated authority for some administrative supplements to NIDA staff. He noted that Council approval is needed for any supplement for 25% or more of the direct costs for the year of the parent application to which the supplement is attached or for any supplement of $100,000 or more in direct costs for any year. Mr. Millstein concluded by noting that administrative and competitive supplements are distinct and serve a range of purposes and that NIDA has begun more rigorously to implement systematic tracking, analysis and oversight of the supplement award process.

6. Update on the Medications Development Program - Dr. Frank Vocci

   Dr. Frank Vocci, Director of the Division of Treatment Research and Development, presented an update of the Medications Development Program. He noted that in 1914 Congress passed the Harrison Narcotics Act allowing physicians to prescribe narcotics only for the treatment of disease and that narcotic addiction was not then considered a disease. In 1929 the National Academy of Sciences and the National Research Council proposed a program to analyze the literature on addictive alkaloids, formulate rules for legitimate use, educate physicians and the public, and develop nonaddicting replacements for morphine/codeine and cocaine. He added that in the 1960s, due to an upsurge in heroin use, researchers started working with the medication methadone to treat opiate addiction. The Harrison Narcotics Act influenced not only the research but also the development of a narcotic treatment program system. In 1974 the Narcotic Addict Treatment Act permitted treatment under a regulatory framework, and in 1995 the Institute of Medicine recommended that regulations be replaced with practice guidelines and minimal regulations. In the early 1990s the Medications Development Program initially concentrated on LAAM, buprenorphine, and depot naltarexone and the development of a cocaine pharmacotherapy program.

   Dr. Vocci noted that with the approvals of LAAM and the buprenorphine products for opiate addiction, NIDA now is shifting towards developing medications for cocaine addiction and, most recently, methamphetamine addiction. He commented that there are over 2 million addicted or heavy cocaine users and about one out of every 10 is in treatment on any given day. Of these, 40 percent are considered primary cocaine addicts and 60 percent are enrolled for secondary treatment. Neuroscience discoveries have led to new medications of interest. Dr. Vocci described the "top down" approach in treating stimulant addiction as using medications marketed for other indications but that have shown some evidence of efficacy for drug dependence in placebo controlled, blinded trials. He added that use of the "bottom up" approach, the translation of laboratory findings to clinical studies and reliance on behavioral, biochemical and neuroimaging techniques, is a growing trend. NIDA uses both approaches.

   He further noted that dopamine transporter inhibitors have been a program focus for 10 years and may have multiple mechanisms of efficacy. Also, ongoing projects being funded for development of immunotherapies include passive immunization using monoclonal antibodies, a cocaine vaccine and a nicotine vaccine. Dr. Vocci concluded by saying that progress is being made in the development of opiate and cocaine pharmacotherapies as well as immunological therapies, in researching the interactions of medications with behavioral therapies, in expanding the methamphetamine treatment program, and in expanding the smoking cessation program.

7. Update on Intramural Research Program - Dr. Barry Hoffer

   Dr. Hoffer updated the Council on the Intramural Research Program (IRP). He announced that Dr. Elliot Stein was recruited as Chief of the Neuroimaging Research Branch and is introducing fMRI into the existing IRP imaging program. Both human and animal fMRI magnets have been purchased in an effort to broaden and enhance NIDA's imaging research focus. Search is under way for a Chief of the PET Research Section in an effort to have a fully integrated imaging program. Dr. Hoffer reported on other staff actions that have added expertise in medicinal chemistry, kappa opioid mechanisms, medications discovery, neurobiology of relapse, and neural protection and regeneration. Newly recruited tenure track investigators will work in the area of in vitro brain slice electrophysiology and confocal microscopy as well as MR physics and development of new and innovative data acquisition paradigms. Dr. Hoffer announced that the newly created Molecular Neuropsychiatry Research Branch, headed by Dr. Jean Cadet, would increase focus on neurodegeneration research. He added that the clinical program has been reorganized to enhance its effectiveness and create operational efficiencies. Additionally a pilot recruitment program will target recruiting hard to find research volunteers. Dr. Hoffer reported that a new clinical director is being recruited to manage the human research program and that Dr. Robert Conley from the University of Maryland has been appointed the new chair for the IRB. He also reported that additional space has been acquired and a state-of-the-art laboratory will be created for new, existing and expanded research programs. Dr. Hoffer reported that a new joint facility for NIDA's IRP and the National Institute on Aging's IRP programs is under way. This new facility will be called the NIH Biomedical Research Center and will have a state-of-the-art vivarium and clinical and laboratory space.

8. Public Comments

   Dr. Volkow opened the floor to comments from members of the public. Mr. Andrew Kessler from the American Psychological Society (APS) congratulated Dr. Volkow on her appointment as Director and informed Council of activities in which the APS and NIDA have been collaborating.

9. Adjournment

   The 84th 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.