Minutes of the 76th Meeting of the National Advisory Council on Drug Abuse

September 12-13, 2000

The National Advisory Council on Drug Abuse convened its 76th meeting at 2:00 p.m. on September 12, 2000 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Alan I. Leshner, Director, NIDA, chaired the overall meeting, and Mr. Richard A. Millstein, Deputy Director, NIDA, chaired the latter part of the September 13 meeting and the application reviews. The meeting on September 12 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 September 13 at 9:00 a.m. and was open to the public. The Council adjourned September 13 at 3:40 p.m.

Council Members Present:

Susan G. Amara, Ph.D.
Hortensia D. Amaro, Ph.D.
Joe D. Bennett, M.D.
Kathleen T. Brady, M.D., Ph.D.
Rand D. Conger, Ph.D.
Gerald H. Friedland, M.D.
Morton E. Goldberg, D.Sc.
Steven C. Hayes, Ph.D.
G. Alan Marlatt, Ph.D.
Clyde B. McCoy, Ph.D.
Kathleen R. Merikangas, Ph.D.
Perry F. Renshaw, M.D., Ph.D.
David L. Rosenbloom, Ph.D.
Kathy Sanders-Phillips, Ph.D.
James E. Smith, Ph.D.
Richard T. Suchinsky, M.D. (ex officio)

Council Members Absent:

Andrea G. Barthwell, M.D.
Linda Fuller, M.D. (ex officio)

Council Chairs Present:

Alan I. Leshner, Ph.D.
Richard A. Millstein, J.D.

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

National Institute on Drug Abuse

Other Federal Employees Present:

Julian Azorlosa - Center for Scientific Review, NIH
Judit Camacho - National Institute of General Medical Sciences
Arlene Chiu, Ph.D. - National Institute of Neurological Disorders and Stroke, NIH
Michael Martin, Ph.D. - Center for Scientific Review, NIH
Christine Melchior, Ph.D. - Center for Scientific Review, NIH
Elliot Postow, Ph.D. - Center for Scientific Review, NIH

Members of the Public Present:

Jane Bailey - Howard University
Christine Carrington, Ph.D. - Howard University College of Medicine
Cathi Coridan - National Mental Health Association
Rex Cowen - NAMC
Glen Fischer - Management Assistance Corporation
Nancy Hamilton - PAR
Alan Kraut, Ph.D. - American Psychological Society
Rachel Loock - TRI
Robert Mathias - MasiMax Resources
Geoffrey Mumford, Ph.D. - American Psychological Association
Regina Vidaver, Ph.D. - Society for Women's Health Research
Patrick Zickler - NIDA NOTES

1. Call to Order

   Dr. Alan I. Leshner called the open portion of the meeting to order and welcomed the Council members, NIDA staff, and visitors. He 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 the 75th Council

   The Minutes of the May 16-17, 2000 meeting were approved as written.

3. Acknowledgement of Council Service

   Dr. Leshner expressed his and NIDA's appreciation for the service of Dr. Susan Amara, Dr. Clyde McCoy and Dr. Morton Goldberg. A certificate of appreciation and plaque were presented to them.

4. NIDA Director's Report

   Dr. Leshner reported recent changes in NIDA staff. Dr. Glen Hanson, a well-respected scientist from the University of Utah, is now on board as the Director for the Division of Neuroscience and Behavioral Research. He noted that Dr. Karen Skinner has done a superb job serving as Acting Director for the last couple of years and has provided outstanding leadership, particularly in the development and application of new technologies. Dr. Skinner continues to focus on the development of infrastructure and scientific technologies that might be better applied to issues of drug abuse and addiction. Dr. Leshner noted that Dr. David Shurtleff continues to serve as Acting Deputy Director in the Division of Neuroscience and Behavioral Research. He also announced that Dr. Cindy Miner was appointed as Chief of the Science Policy Branch, OSPC. Dr. Leshner announced that Dr. Jaylan Turkkan would be leaving NIDA to become Vice President of Research at the University of Buffalo. He also called attention to many staff honors and awards as highlighted in the Director's Report.

   Budget

   Dr. Leshner announced that under the proposed Senate/House budget, NIDA would receive a $100 million increase over FY 2000, which would be about a 15 percent increase, the NIH average. The President's 2001 budget request would give NIDA $725,467,000, an increase of 5.5% over FY 2000, but with a success rate of 21% reduced from 31% last year. The House and Senate mark would keep the success rate at 31%.

   Shaping the Research Agenda

   Dr. Leshner reported that NIDA had sponsored a series of meetings. He mentioned a meeting of international scientists in conjunction with the 62nd annual meeting of the College on Problems of Drug Dependence that was held in June in Puerto Rico that discussed the latest studies on drug dependence and abuse and also featured meetings focused around gender issues. This was a successful international meeting of high-level scientists interested in forming collaborations in the U.S. Dr. Leshner mentioned a series of lectures hosted by the Behavioral Science Working Group in collaboration with the American Psychological Association around the theme of the Vulnerability to Drug Abuse that looked at both genetics and environmental factors. NIDA staff also co-chaired a Career Development Workshop at this meeting. The NIDA-sponsored workshop, "Computational Models: Applications to Drug Abuse," explored how computational and theoretical modeling could be used in drug abuse. A similar meeting, the Cell Biology of Addiction, was successful in bringing together researchers in cell biology of addiction and those interested in other aspects of cell biology, particularly the application of new technologies to cell biology. Dr. Leshner noted the Community Epidemiology Work Group (CEWG), a group that discusses current and emerging patterns and trends in drug abuse, has been very successful as an early warning system about emerging drug problems.

   He also noted other meetings and mentioned that NIDA will cosponsor with the World Health Organization and the National Inhalant Prevention Coalition an international meeting, "Street Children and Drug Abuse: Social and Health Consequences," to examine street youth, violence and drug abuse as well as to launch an updated report discussing studies on inhalant use among adolescents. Four NIDA symposia are planned at the Society for Neuroscience meeting in New Orleans. The NIDA National Drug Abuse Treatment Clinical Trials Network Steering Committee will meet in September and October. NIDA will also cosponsor a trans-NIH meeting, "The Science of the Placebo: Toward an Interdisciplinary Research Agenda," to be held in Bethesda in November.

   Initiative Implementation

   Dr. Leshner noted that Council was involved in both the development and structuring of the Strategic Plan on Health Disparities. The four working groups, the African American Researchers and Scholars Group, the National Hispanic Science Network, the Asian and Pacific Islanders Workgroup, and the Native American-Alaskan Native Workgroup, have been helpful in developing programs to recruit minorities and have begun mentoring young scientists interested in drug abuse research. All of the workgroups will meet together for the first time in November. Dr. Leshner also mentioned that a NIDA grantee will be one of the speakers at the Hispanic Heritage Days at NIH.

   Dr. Leshner talked about the intertwined epidemics of HIV/AIDS, drug abuse, and hepatitis C and the need to focus on other blood-borne infections. He noted a well-attended meeting NIDA cosponsored with the Centers for Disease Control and Prevention and the Center for Substance Abuse Treatment that brought attention to NIDA's commitment to these issues. Dr. Leshner added that a large number of NIDA staff were involved in developing a recently released community-based outreach booklet entitled "Principles of HIV Prevention in Drug-Using Populations".

   Dr. Leshner noted that NIDA was instrumental in the formation and evolution of the Global Research Network, a multinational infrastructure for research on prevention and treatment of HIV/AIDS on a worldwide scale.

   Dr. Leshner mentioned that NIDA hosted the "Neuroimaging of Brain and Behavioral Development Following Early Drug Exposure" meeting that explored the value of combining pediatric neuroimaging and the assessment of early exposure to drugs of abuse. He pointed out that there is evidence from brain imaging studies of persistent effects of prenatal exposure on later brain development and that this is a major NIDA initiative area.

   Dr. Leshner noted that NIDA's millennial goal is to improve drug abuse treatment throughout the nation using science as the vehicle in treatment. NIDA treatment initiatives will develop new treatment components and also improve existing ones. He mentioned a recent meeting held jointly with the Therapeutic Communities of America that brought together people from the treatment provider community with treatment researchers to take on the task of understanding therapeutic communities and the factors that make them effective. The other part of the treatment initiative is moving promising drug abuse treatments from research into real life settings. The cornerstone of this is the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) that will be significantly expanding over the next couple of months. The CTN will have its second kickoff meeting in October in Los Angeles and will have a major conference with a number of other organizations focusing on blending clinical practice and research.

   Dr. Leshner spoke about blending clinical practice and research and mentioned there will be a conference called "Blending Clinical Practice and Research to Enhance Drug Addiction Treatment" that will be held in Los Angeles in November. Researchers and practitioners will examine ways to enhance ongoing efforts to ensure that research is incorporated into practice settings.

   Dr. Leshner noted that the Community Anti-drug Coalition of America has translated the NIDA treatment booklet into one of their "Practical Theorist" series. Also noteworthy are many new publications as part of the education campaign that is sending a positive message to young people, particularly the NIDA "Toolbox" consisting of materials useful in real life settings.

   Council suggested that NIDA needs to encourage more studies on marijuana use because it is understudied and is very prevalent, particularly among adolescents. Council also suggested NIDA organize initiatives to look at the population diagnosed with mental illness, substance abuse and HIV that has complicated prevention and therapy.

5. Women, Gender and Drug Abuse - Dr. Cora Lee Wetherington

   Dr. Wetherington announced that the Office of Research on Women's Health at NIH celebrated its tenth anniversary, and last year the Society for Women's Health Research, an advocacy group to promote research in the area of women's health in gender differences, also celebrated its tenth anniversary. Ten years ago there was virtually no gender-based research on drug abuse. In the late 70s some research was being conducted with prenatal exposure to heroin and marijuana. She noted that the 1994 NIDA Conference on Drug Addiction Research and the Health of Women identified two areas to study: 1) females of all ages, not just childbearing women, and 2) gender differences. NIDA developed strategies to increase research in these areas and was exemplary at NIH in research of females and gender differences. She talked about the prevalence of drug use and noted that rates of dependence are greater for males than for females. She added that males have a greater opportunity to use drugs than females and that males were more likely to become dependent on marijuana and alcohol whereas females were more likely to become dependent on anxiolytics, sedatives and hypnotics. Dr. Wetherington pointed out that animal models have shown sex differences in speed of acquisition of self-administration, prevalence of acquisition, and also with relapse. She also noted that women have an increased feeling of "high" during the follicular phase and that they have more nicotine withdrawal symptoms and depression during the late luteal phase; how this effects treatment is largely unexplored. Predictors of drug use, progression and dependence are gender-sensitive and gender-specific, and this raises questions as to whether gender-based predictors affect prevention and treatment. Dr. Wetherington concluded that we have made progress in the last decade but much research remains to be done in the area. Council commented that the findings on gender-sensitive and gender-specific factors might have implications for the work NIDA does beyond those investigations on gender issues.

6. International HIV Research Strategies: Global Research Network Efforts - Dr. Henry Francis

   Dr. Francis noted that NIDA is involved in international research because HIV is rapidly increasing in international populations and that drug use is one of the significant vectors in transmitting HIV in most parts of the world. He also noted that NIDA is one of three institutions that funds most of the international behavioral and other research relevant to drug use and its complications, and is a reservoir of information and research knowledge applicable to problems of drug use not only here in the United States, but internationally as well. The Global Research Network (GRN), part of NIDA's international activities, consists of approximately 80 members throughout the world. NIDA staff started this process several years ago at the 12th International AIDS meeting where they brought together a group to share information and make recommendations on how to develop a research agenda. The GRN's initial target was to advance the science of HIV prevention in drug use but it has expanded to include reviewing, on an annual basis, emerging trends and findings of qualitative and quantitative research in HIV prevention in injecting and non-injecting drug users, facilitating prevention and treatment interventions in an international audience, and exploring how HIV prevention has relevance to multiple epidemics. The GRN is looking at overlapping infectious and non-infectious disease issues within the global population. They will focus on issues of HIV prevention and related diseases in drug using populations and try to link with people who do HIV work but do not necessarily focus on the drug using population. They will also introduce the concept of educating policy makers to be participants in scientific meetings to gain information on doing prevention for HIV and hepatitis in drug using populations.

   Dr. Leshner added that the Global Research Network needs to be an integral part of bigger international meetings and that this can be an important international infrastructure. He noted the need to intervene early enough to prevent progression.

7. NIDA and South Africa: Exploring Interests and Opportunities - Dr. Lula Beatty

   Dr. Beatty reported on her trip to South Africa and NIDA's involvement there. The DHHS initiatives include the U.S.-South Africa Bi-national Commission; the Gore-Mbeki Commission, which has seven committees and is designed to help promote cooperation between Africa and the U.S.; a Health Subcommittee whose priorities are HIV/AIDS, emerging and reemerging infectious diseases including TB, mental health, substance abuse, among others; a Memorandum of Understanding that lays the groundwork for continued understanding between the U.S. and South Africa; and a LIFE (Leadership and Investment in Fighting an Epidemic) initiative to address the AIDS pandemic. Dr. Beatty noted that there was a 70% increase in the number of grants to South African institutions and investigators since 1996. She mentioned the meeting in South Africa that was held in July and sponsored with the Center for Drug Abuse Research, Howard University, NIDA, the Centers for Disease Control and Prevention, and others in which prominent South African officials were in attendance. The objectives of the meeting were: to strengthen collaborative relationships, identify partnerships, identify best practices from here that could be used there, identify sources for funding, and identify strategies for long-term human resource development. Workgroups were developed at the meetings to look at prevention, treatment, HIV/AIDS, violence and capacity development. These workgroups prepared a report as a way of stimulating ideas and keeping the momentum going. The meeting has stimulated research interests on both sides, including interest in maternal exposure to AIDS and substance abuse in South Africa, infectious diseases in the correctional setting, effective HIV/AIDS intervention strategies for young women of color targeting pre-adolescent youth, telepsychiatry intervention in drug abuse treatment, and many others. Dr. Beatty noted several activities that are planned, including sponsoring a roundtable with South African researchers to identify ways to best target drug abuse and HIV/AIDS research. A NIDA South African Committee was established to plan for future activities. This group will determine priority areas and present an overall plan to the Director, NIDA.

   Dr. Leshner added that the AIDS meeting was a very inspirational meeting and that South African officials are very committed and involved. Some Council members described it as the best of the 13 AIDS meetings that have occurred. Council noted that a concerted, focused effort needs to be made to help. Dr. Leshner also added that this is an important opportunity to bring the power of science to bear on drug abuse.

8. Update on the National Drug Abuse Clinical Trials Network - Dr. Betty Tai

   Dr. Tai gave an update on the National Drug Abuse Treatment Clinical Trials Network (CTN). She noted the mission of the CTN is to conduct community-based clinical studies of promising therapies for drug addiction and to ensure the timely transfer of research results to physicians, providers and their patients. She talked about the structure of the CTN that allows substantial NIDA scientific and programmatic involvement. The six nodes are the functional units and are comprised of a regional research and training center situated at a university, plus community-based treatment programs. These nodes have substantial geographic coverage and a diverse patient population. Anticipating participation of additional nodes, Dr. Tai added that there was a need to streamline the governing body so the Steering Committee created an Operations Committee made up of five subcommittees and many protocol teams (half university researchers and half treatment program representatives). She added that there are many ongoing activities designed to establish infrastructure, develop policies and initiate studies. Dr. Tai mentioned that communication was a challenge across all levels of the CTN (within and between the nodes, between the nodes and NIDA, within and between the protocol teams). She talked about the required elements to initiate a study and to start to enroll patients and how the lead investigator needs to forward the protocols and required elements to the nodes and collect this documentation and forward it to NIDA, which, in turn, performs site visits and authorizes the study to start. Dr. Tai discussed training issues, both general training to teach general research concepts, and protocol-specific training to teach how to deliver specific therapies. Dr. Tai talked about disseminating CTN information through NIDA quarterly reports and information brochures. She also noted the need to develop protocol knowledge material. The protocol knowledge dissemination includes a Good Research Practice manual and protocol brochures. She also talked about medical safety and the establishment of a Data and Safety Monitoring Board that provides interim analyses of efficacy and safety data. The lead investigator has final responsibility for safety of the enrolled patients and adverse events reporting. Dr. Tai updated Council on the research concepts, including medication, behavior and integrated therapies. She also mentioned the research concept selection criteria for the second group of protocols that will be slightly different and complement the first ones. Five new concepts/protocols are Buprenorphine/Naloxone in adolescents, smoking cessation in the community treatment programs, aftercare follow-up, qualitative/quantitative assessment, and hepatitis C screening, education, and evaluation. She added that the new nodes will add scientific breadth and increase geographic diversity, but future challenges will include learning how to integrate new nodes into existing nodes and how to continue to communicate effectively.

9. NACDA Recommended Guidelines for the Administration of Drugs to Human Subjects - Dr. A. Thomas McLellan

   A Council subcommittee has developed revisions to the existing NACDA Recommended Guidelines for the Administration of Drugs to Human Subjects. A draft was developed with NIDA staff and returned to Council for comments. Dr. McLellan summarized the recommended changes. Council discussed several parts of the document and proposed further changes to the draft. Council members commented on the need to balance science and human subject concerns, to train the staff involved, and to obtain outside advice if necessary expertise is lacking. Various comments and changes were added to the draft. Council then unanimously voted to accept these guidelines. Dr. Leshner thanked Council for their input and noted that NIDA will work with their comments as the guidelines are refined.

10. The Emerging Role of Data Safety and Monitoring Boards - Dr. Robert Walsh

    Dr. Walsh talked about the role of Data and Safety Monitoring Boards (DSMBs) and the new NIH policy, starting with the October 2 receipt date, requiring that monitoring plans be submitted for Phase I and II clinical trials. He noted that a DSMB is needed for earlier trials if the trials have multiple clinical sites, are blinded or employ high-risk interventions or vulnerable populations. Dr. Walsh also noted that the function of the DSMB is to determine if the benefit or harm for the patients in the trial differs from that of a placebo or alternative and whether or not a trial should be stopped. Usually the DSMB has from 3-12 members appointed from either outside the sponsoring organization or from within and having no connection to the trial. He explained that the principal investigator is responsible for providing a description of the monitoring plan to be submitted as part of the application. This plan should include a description of the reporting mechanism for serious adverse events to the IRB, FDA and the NIH, and a plan for stopping if safety concerns arise. The Scientific Review Group will look at the general description and may comment in an administrative note in the summary statement. A detailed monitoring plan is then reviewed and approved by NIDA before the trial can begin. Council made suggestions for changes and additions to the Guidelines. Dr. Walsh gave the websites for NIH guidance and policy concerning data and safety monitoring.

11. New Outreach Activities - Dr. Timothy Condon

    Dr. Condon reported on NIDA's outreach activities. He noted that NIDA's science education activities include a grant portfolio and in-house program, focusing on curriculum projects in kindergarten through 12th grade. Information is distributed on a website and in public libraries. Every middle school, both public and private, in the country has received a "NIDA Goes to School" box containing accurate scientific information about drugs of abuse. This has been so successful that NIDA has launched two additional projects. One is to develop a curriculum and videos for teachers to use in elementary school classrooms, and the other is a packet for high school students with a new interactive CD ROM that was developed by NIDA and the NIH Office of Science Education. Dr. Condon noted that the internet is becoming a major information dissemination vehicle and that NIDA plans to launch a new home page. A very successful website is the "clubdrugs.gov," site having 319,000 hits and routing users into the NIDA home page. He mentioned that NIDA had launched the anabolic steroid abuse initiative. Dr. Condon showed videotapes of public service announcements launched by NIDA. There were seven ads on radio and TV in both English and Spanish and collateral materials to go with these announcements, some geared towards children and some towards their parents. NIDA also developed an art card to go with the ad campaign. The 1-800 number at the end of the videos was switched to a web address, "stopdrugaddiction.org," that also routes users into the NIDA home page, allowing NIDA to count how many hits obtained as a result of national airing of these public service announcements. Dr. Condon spoke about special population outreach publications, giving examples such as the "Principles of Prevention" brochure translated into Spanish and a Latino brochure developed for adolescent drug abuse. He also mentioned a "Walking a Good Path" calendar for 2001 that will reach many different American Indian tribes. Dr. Condon showed the NIDA clinical toolbox, containing treatment manuals, drug abuse counseling materials, a laminated card about treatment principles, the NIDA publications catalog, and NIDA Research Reports. This kit was sent to 12,000 treatment sites across the country. He also noted an upcoming meeting in November in Los Angeles entitled "Blending Clinical Practice and Research to Enhance Drug Addiction Treatment." Representatives from the different CTN nodes and the community treatment programs will be there to examine ways to enhance ongoing efforts to ensure that research is incorporated into practice settings. Dr. Condon noted the annual Prism Awards that are cosponsored with the Robert Wood Johnson Foundation and the Entertainment Industries Council. These awards are presented for accurate depictions of drug abuse and addiction in the media. This yearly, one-hour televised special will be aired on 141 stations across the United States.

    Council suggested maintaining an icon regarding women and gender issues on the NIDA main web page. It was also suggested that NIDA find a way to evaluate the different strategies to convey most effectively the message that drug addiction is a brain disease. Council raised a question regarding NIDA educating primary care physicians on drug and alcohol addiction treatment. Dr. Leshner noted that NIDA has materials directed towards medical professionals. He also noted that NIDA's efforts in the broader NIH community have resulted in greater attention to drug abuse by other Institutes. Council suggested that it would be useful for NIDA to assemble information on the grant portfolio for each Council meeting, giving the number of grants, dollar amounts, and length of award to help determine what areas were in need of more support. Dr. Leshner thanked Council for these important suggestions.

    Dr. Kathleen Brady addressed Council on the draft document, "Distribution of Genetic Data and Biomaterials from the NIDA Center for Genetic Studies." She noted that NIDA had issued an RFA in 1998 and funded a few centers for genetics research. This group of PIs formed the NIDA genetics consortium and the NIDA Center for Genetics Studies, a repository for the data. A Council subcommittee was formed to develop policy to maximize the use of the data and samples in the repository and make it available to qualified investigators. A committee consisting of four people of appropriate scientific background and skills and one bioethicist will review the application requests for data access. Dr. Brady explained how the guidelines specify what the PIs can and cannot do with the data and the reporting to NIDA of their findings. Mr. Millstein commented that these documents have been on the web site for two months and have been shared with the NIH General Counsel, and the draft will be sent to all Council members for their approval.

12. Public Comments

    Mr. Millstein opened the floor to any comments from members of the public. Dr. Regina Vidaver from the Society for Women's Health Research in Washington, D.C. announced the Society's tenth Scientific Advisory Meeting to be held October 26-27, 2000 in Washington, D.C. on Drug Addiction, Sexually Transmitted Diseases and Pain. She added that Dr. Leshner and Dr. Wetherington will be part of the program.

Mr. Millstein adjourned the 76th meeting of the National Advisory Council on Drug Abuse at 3:40 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.