Section 301 and Title IV of the Public Health Service Act, as amended.
||FY 2006 Actual
||FY 2007 Continuing Resolution
||FY 2008 Estimate
||Increase or Decrease
This document provides justification for the Fiscal Year 2007 activities of the National Institute on Drug Abuse, including HIV/AIDS activities. A more detailed description of NIH-wide Fiscal Year 2007 HIV/AIDS activities can be found in the NIH section entitled "Office of AIDS Research (OAR)." Detailed information on the NIH Roadmap for Medical Research may be found in the Overview section.
Research on drug abuse over the past thirty years has brought us a deeper understanding of the disease of addiction, allowing us to develop more targeted strategies for its prevention and treatment. This is NIDA's continuing priority, along with combating the spread of HIV/AIDS, linked to drug abuse and the risky behaviors it elicits. Therefore, NIDA's goals are both short and long-term: to address the needs of people already suffering from drug abuse and addiction while at the same time developing the knowledge that will lead to more effective prevention and treatment of drug abuse and addiction in the future. NIDA- supported research also promotes investigation of strategies to ensure the "translation" of prevention or therapeutic interventions for the communities that can benefit from them.
While multiple challenges remain to fulfill this mission, many new opportunities have dawned to help overcome them. The challenges are familiar ones: high rates of drug abuse and low rates of treatment; lack of physician participation in identifying and treating substance abuse; lack of treatment integration with health care programs and major medical insurers; lack of pharmaceutical industry involvement in developing anti-addiction medications; etc. The opportunities, on the other hand, promise proactive approaches that can help overcome these obstacles through the application of revolutionary genetics and molecular biology tools, modern brain imaging technology, ground-breaking knowledge on brain development, and promising preclinical and clinical trials of anti- addiction medications and novel behavioral treatments.
Current Drug Abuse Prevalence
Knowledge from scientific research on drug abuse and addiction has prompted notable shifts in attitudes and behaviors toward drugs. Today approximately 840,000 fewer young people are using illicit drugs than in 2001 - an impressive 23 percent reduction.1 Use of nicotine is now lower than at any time since the Monitoring the Future Survey (MTF) of students began in 1975. Nevertheless, in 2005, an estimated 19.7 million Americans aged 12 and older were current (noted as "past month" in the survey) illicit drug users.2 And, according to MTF, nearly 50 percent of 12th graders will have tried an illicit drug by the time they graduate from high school. These are unacceptably high numbers rendered even more problematic in that drugs of abuse may be especially deleterious to adolescent brains.
Addressing the Latest Trends
Prescription drugs. Drug abuse can apply to more than abuse of illicit substances. In fact, the MTF reports in 2006 that roughly one in ten 12th graders used the prescription pain reliever Vicodin nonmedically during the past year - abuse second only to marijuana. In general, prescription drug abuse is an emergent problem that appears to be increasing in certain populations, and therefore is the subject of several NIDA initiatives.
Physician Outreach. NIDA is undertaking a Physician's Outreach Initiative to engage the medical community in identifying substance abuse problems, including prescription drug abuse, in their patients and to raise awareness of substance abuse and addiction as a primary care health issue. NIDA will (1) work with the Office of National Drug Control Policy (ONDCP) to increase drug abuse training for physicians; (2) partner with the American Medical Association to improve physician-patient communication about substance abuse; and (3) sponsor four National Centers of Excellence in Physician Information to conduct research
and develop messages and dissemination avenues for medical students, primary care, and family practice residents to raise awareness of substance abuse issues and of NIDA as a resource.
Methamphetamine. Methamphetamine continues to blight communities across the country, evincing marked increases in abuse consequences (e.g., treatment admissions rising from 28,000 to about 150,000 a year from 1993-2004)3. NIDA is pursuing several different therapeutic approaches, including both medications and behavioral therapies aimed at
abstinence, relapse prevention, and cognitive dysfunction caused by long-term abuse.
Drug Abuse and HIV/AIDS. HIV/AIDS, in which drug abuse is a major factor, continues to disproportionately affect African Americans and other minority populations. To overcome identified obstacles for differentially affected populations, NIDA released two program announcements in 2006 calling for drug abuse and mental health research on HIV/AIDS among African Americans, along with research on criminal-justice-related health disparities in this population.
New Directions in Drug Abuse Research
New knowledge is leading us to new solutions that address the multiple factors contributing to addiction. For example, an exciting new initiative being undertaken with the National Cancer Institute (NCI) will examine the interplay of gene-environment-development (GED) interactions and promises to aid in mitigating developmental risk. Fascinating results are already emerging from both basic and clinical social neuroscience studies, where non-invasive
brain imaging techniques are providing information on the brain circuits involved in social behaviors and how these are affected by drug abuse.
Advances in neuroscience research, which yield a more accurate understanding of addiction as a chronic disease of the brain, have also inspired new approaches to treatment. Whereas formerly, medications development efforts zeroed in on the chemical dopamine and the brain reward system, therapeutic approaches are now also focusing on other brain circuits (memory, executive control, motivation), other neurotransmitter systems (cannabinoids, GABA, glutamate), and other strategies (vaccines, slow-release delivery systems).
For behavioral approaches, NIDA is encouraging investigators to evaluate the use of functional imaging technologies to optimize cognitive behavioral interventions (i.e., to develop messages that activate brain regions promoting greater acceptance) and to use neurofeedback to strengthen targeted brain circuits. The latter approach was shown to be useful in teaching subjects to decrease their emotional reaction to pain by activating brain areas that control
FY 2008 Justification by Activity Detail
Overall Budget Policy: Investigator-initiated research projects, new investigator research and career development are NIDA's highest priorities. In the field of drug abuse, NIDA has identified several important research training areas for enhancement, including clinician researchers, inter- and trans-disciplinary researchers, underrepresented populations, and chemists. NIDA is addressing these gaps through multiple career development mechanisms and interdisciplinary research training grants, which include plans for recruiting
underrepresented minority trainees. NIDA has identified several other areas important for the nation's research competitiveness and directs resources accordingly. Investigator-initiated grant applications are carefully evaluated for all major research programs. This process includes a scientific panel review, which helps determine the level of recommended support, if any. Results are presented to the NIDA Advisory Council for concurrence. The level of
support provided for NIDA-solicited projects, stemming from Requests for Applications (RFAs) for example, are also evaluated. NIDA balances solicitations issued to the extramural community (in areas it wants to stimulate) with funding made available to support investigator initiated projects.
Clinical and Basic Neuroscience: Clinical and basic neuroscience represent two programs in NIDA that work together to enlarge the understanding of neurobiological, genetic, and behavioral factors that underlie drug abuse and addiction. Specifically, they examine the factors affecting increased risk and/or resilience to drug abuse, addiction, and drug-related disorders; the mechanisms of addiction; and the effects of drugs on the brain and behavior.
Together, they provide the fundamental information to develop and inform prevention and treatment interventions for drug abuse and addiction.
Budget Policy: The 2008 estimate for this program area is $429.1 million, the same level as the FY 2007 estimate. The program plans for 2008 include several targeted initiatives to stimulate research in emerging scientific areas or those under-represented in the current research portfolio. NIDA will expand its portfolio to investigate the social brain, to include studies on genetics, molecular biology, behavioral pharmacology, and brain imaging. Plus, NIDA will
advance a Genes, Environment, and Development Initiative (GEDI) to solicit research investigating the interplay among these variables in the etiology of substance abuse in humans. NIDA will also encourage and support the development of next generation technologies to identify and catalogue the myriad functional changes to the DNA (i.e., epigenetic modifications) that can result from exposure to a wide range of environmental variables, such as quality of parenting. Additionally, in FY 2007, NIDA will call for studies of medications
and genetic interventions to facilitate the "unlearning" or extinction of conditioned drug responses - often the promoters of relapse to drug abuse. Resulting research will be used to guide and implement combined behavioral and pharmacological interventions to enhance drug abuse treatment and reduce relapse. Finally, NIDA promotes research to foster the development of more effective HIV prevention interventions, targeting the role of drug abuse
on HIV transmission and acquisition.
Epidemiology, Services and Prevention Research: This program area is also a major one within NIDA. It seeks to promote integrated approaches to understand and address the interactions between individuals and environments that contribute to the continuum of problems related to drug abuse. The vision is to support research to prevent drug abuse and optimize service delivery in real-world settings.
Budget Policy: The 2008 estimate for this program area is $249.4 million, a decrease of $204 thousand below the FY 2007 estimate. Highlights of program plans for 2008 follow. Given the close relationship between drug abuse and crime, NIDA will continue to support targeted research on how drug abuse treatment and criminal justice systems interact through the Criminal Justice Drug Abuse Treatment Research Studies (CJ-DATS). To further this research,
centers within CJ-DATS will be re-competed in FY 2008. Another major area is prescription drug abuse. NIDA will address it through a multi-pronged strategy that includes epidemiological studies and basic, preclinical, and clinical research, including: (1) a collaboration with the National Institute on Aging and the National Institute of Dental and Craniofacial Research on a major solicitation (estimated at $3 million for FY 2008) for crossdisciplinary
studies to investigate the use of opioids for pain treatment and to better understand the nexus of abuse and addiction to them; and (2) research on the development of therapeutic agents with reduced abuse liability. Examining factors that predispose or protect against opioid abuse and addiction will help develop screening and diagnostic tools for primary care physicians to assess the potential for prescription drug abuse in their patients. Other tools being
developed include those designed to assess the impact of social environmental variables on decision-making and drug abuse risk by looking at social setting, parenting, education, neighborhood, and public policies. NIDA is encouraging research on the use of the Internet and other web-based communication strategies to acquire information that can be integrated into prevention efforts.
Portrait of a Program: Criminal Justice Drug Abuse Treatment Research Studies Integrating Drug Abuse Treatment in Public Health and Safety Settings
FY 2007 Level: $35.1 million
FY 2008 Level: $35.1 million
Change $ 0.0 million
Research findings from basic and clinical neuroscience have shown addiction to be a complex disease of the brain and behavior from which people can recover with treatment, as is the case with most medical diseases. The concept of drug addiction as a complex disease needs to be understood if society is to effectively address the burgeoning problem of drug-related crime and addicted offenders in this country, who, if not effectively treated, will return to communities and to the vicious cycle of drug abuse, crime, and incarceration. But because addiction is still frequently seen as a moral failing, or a "personal" problem, the needed public health response has been overshadowed by the public safety concern. Combining the two - public health and public safety -
NIDA launched CJ-DATS in 2002, which aligns with its multi-pronged approach to more rapidly move promising science-based drug addiction treatments into community settings. It is a 5-year research program that ends in September 2007, but NIDA intends a competitive review. Starting in 2008, CJ-DATS will focus on
implementing research-based drug abuse treatment interventions in criminal justice settings. It seeks to bring new treatment models into the criminal justice system and thereby improve outcomes for offenders with substance use disorders. It represents a collaboration of NIDA with the Substance Abuse and Mental Health Services Administration, Centers for Disease Control and Prevention, Department of Justice agencies, and a host of drug treatment, criminal justice, and health and social service professionals. Given recent studies showing the effectiveness of drug abuse treatment in reducing drug use and re-incarceration, NIDA will continue to invest in CJ-DATS to test additional treatment models. Other institutes, namely NIMH and NIAAA, will serve as key
partners for the renewal.
To disseminate research findings and effect system-wide change, in July 2006 NIDA released a landmark publication entitled Principles of Drug Abuse Treatment for Criminal Justice Populations, designed to advance the concept of addiction as a brain disease and the importance of treating it. The principles emphasize the need for customized strategies that can include behavioral therapies, medication, and consideration of other mental and physical illnesses. The key message is that drug abuse treatment works, especially with community
involvement and support, and brings about reduced drug abuse, criminal recidivism, and relapse to addiction. To reinforce these messages, NIDA will continue to reach out to judges and others in the criminal justice system to
educate them about the behavioral and biological aspects of addiction through intensive training workshops.
Pharmacotherapies and Medical Consequences: This program area at NIDA is responsible for medications development aimed at helping people recover from drug abuse and addiction and sustain abstinence. Capitalizing on research showing the involvement of many different brain systems, beyond the dopamine system, in drug abuse and addiction, NIDA's medications development approach is pursuing newly defined targets and approaches to treatment. This program area also seeks solutions for the medical consequences of drug abuse and addiction,
including infectious diseases such as HIV.
Budget Policy: The 2008 estimate for this program area is $116.6 million, the same level as the FY 2007 estimate. Program plans for 2008 follow, along with expected accomplishments. Highest priority will go to testing promising and novel therapies for different drugs of abuse, particularly stimulants and cannabis. To allow NIDA to be more nimble in its approach to developing medications, the program plans to test more compounds originating in the lab than in the marketplace. In a similar vein, NIDA has a FY 2007 RFA to stimulate research for the design, synthesis, and pharmacological evaluation of new classes of compounds as potential treatment agents for cocaine, methamphetamine, or cannabinoid addiction - a major push of NIDA's medications development program (see portrait).
Portrait of a Program: Development of Addiction Medications
FY 2007 Level: $88.9 million
FY 2008 Level: $88.9 million
Change $0.0 million
Breakthrough discoveries in the last decade have led to a profound transformation in the understanding of the mechanisms and consequences of drug abuse and addiction. The current picture offers unprecedented detail and a
unique opportunity to translate the products of NIDA's combined research into new, effective pharmacotherapies that could, either by themselves or combined with validated behavioral therapies, help alleviate the personal and social
impact of this complex disease. NIDA's Medications Development Program is ideally positioned to harness the potential of this vastly improved understanding through a nimble and multi-pronged approach. For example,
whereas NIDA's focus in the past rested on the reward system, it is now known that other parts of the brain are equally implicated in drug abuse and addiction processes, calling for new paradigms in addiction treatment. Several innovative treatment approaches have proven feasible and are now progressing to more advanced stages of research and development. Projects in this context include work on medications designed to diminish conditioned responses, promote new learning, and inhibit stress-induced relapse. Next-generation pharmaceuticals will also take advantage of knowledge gleaned from human genome studies to elucidate how a person's genetic makeup affects his or her response to a therapeutic medication. This will help us to better tailor treatments according to a person's genes.
Another alternative strategy for treating drug addiction, in which NIDA is currently investing, is immunotherapy, including support for development of a methamphetamine vaccine. Unlike conventional small molecule therapy, which targets the neural pathways/receptors involved in drug addiction, immunotherapy targets the drug itself. Addiction immunotherapies would cause the body to generate antibodies that bind specific drugs while they're still in the bloodstream, blocking their entry into the brain. The resulting reduction of reinforcing effects is expected to prevent relapse. NIDA has released a FY 2007 RFA to support activities aimed at generating the data needed to submit an Investigational New Drug (IND) application to the Food and Drug Administration for Phase I clinical trials of candidate vaccines for methamphetamine addiction.
Clinical Trials Network: NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN), which now comprises 17 research nodes and more than 240 individual community treatment programs, serves 34 States plus the District of Columbia and Puerto Rico. Plus, it tests the effectiveness of new and improved interventions in real-life community settings with diverse populations. The CTN also serves as a platform to help NIDA respond to emerging public health areas. The CTN serves as an effective research platform for 31 additional research grants and a training platform for 60+ research fellows and junior faculty.
Budget Policy: The 2008 estimate for this program area is $54.4 million, the same level as the FY 2007 estimate. The program plans for 2008, along with expected accomplishments, are to re-compete some of the CTN nodes, or centers and to continue support of CTN trials evaluating promising medications and other treatment approaches in diverse patient populations. For example, CTN studies focusing on comorbid conditions include: (1) testing a slow-release form
of methylphenidate (i.e., Ritalin) to help drug-abusing adolescents and adult smokers with attention deficit hyperactivity disorder achieve abstinence and (2) assessing interventions to reduce HIV risk behaviors and other sexually transmitted infection among at-risk populations in community drug treatment settings. NIDA is also eager to advance new HIV rapid-screen technologies and counseling in CTN-affiliated community treatment programs and is also testing HIV screening practices in the criminal justice system through CJ-DATS. Another
treatment protocol to be tested in NIDA's CTN in FY 2008 will evaluate the effectiveness of a 12-step facilitation intervention to foster the initiation of and lasting involvement with the traditional fellowship activities of such groups as Alcoholics or Cocaine Anonymous and thus achieve prolonged abstinence.
Intramural Research Program: NIDA's Intramural Research Program (NIDA-IRP)
performs cutting edge research within a coordinated multidisciplinary framework. NIDA-IRP attempts to elucidate the nature of the addictive process; to determine the potential use of new therapies for substance abuse, both pharmacological and psychosocial; and to decipher the long-term consequences of drugs of abuse on brain development, maturation, function, and structure, and on other organ systems.
Budget Policy: The 2008 estimate for this program area is $81.2 million, a decrease of $573 thousand, or 0.7 percent below the FY 2007 estimate. NIDA plans to identify areas of potential savings within this program to achieve our goals and accomplishments. The program plans for 2008, along with expected accomplishments, are derived from support of ongoing programs covering a wide variety of drug abuse and addiction issues. It covers basic research on the actions and consequences of abuse of marijuana, opioids, cocaine, methamphetamine, and ecstasy; the development/improvement of drug detection devices; the relationship between drug abuse and obesity; comorbid drug abuse and mental illness; and the development of medications and other treatments for drug abuse and addiction. A study exemplary of research conducted at the IRP has uncovered the ability of different brain receptor types to combine and thereby generate a broader range of neuronal responses once specific molecules bind to them - presenting exciting possibilities for dramatically expanding the range of medication options. NIDA-IRP is instrumental in understanding the mechanisms
of methamphetamine-induced neuronal apoptosis (a type of cell death), including which genes are up-regulated or down-regulated in response to the drug. Understanding these mechanisms will help identify potential target molecules that can be either blocked or enhanced to prevent, treat, or mitigate the damage caused by methamphetamine.
Research Management and Support (RMS): NIDA RMS activities provide administrative, budgetary, logistical, and scientific support in the review, award, and monitoring of research grants, training awards, and research and development contracts. RMS functions also encompass strategic planning, coordination, and evaluation of NIDA's programs, regulatory compliance, international coordination, and liaison with other Federal agencies, Congress, and the public. NIDA currently oversees more than 1826 research grants, as well as more than 427 research and support contracts.
Budget Policy: The 2008 estimate for this program area is $56.4 million, an increase of $559 thousand, or 1.0 percent above the FY 2007 estimate. The program plans for 2008, along with expected accomplishments, are as follows. NIDA will continue to develop informational products, such as research reports and public service announcements, on various drugs of abuse. These materials are aimed at diverse audiences, including the general public, HIV high-risk populations, and educators. Outreach activities to physicians and to NIDA's constituency groups help raise awareness of substance abuse issues and get the word out with regard to promising prevention and treatment strategies.
1 Johnston, LD et al. Monitoring the Future Study (NIDA-funded grant). University of Michigan's Institute for
Social Research, Ann Arbor, MI, December 2006.
2 SAMHSA, Office of Applied Studies, 2005 National Survey on Drug Use and Health.
3SAMHSA, Office of Applied Studies. Treatment Episode Data Set (TEDS): 1994-2004, National Admissions to
Substance Abuse Treatment Services, DASIS Series: S-33, DHHS Pub No. (SMA) 06-4180, Rockville, MD, 2006.
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