COGNITIVE APPROACHES TO ADDICTIVE PROCESSES Release Date: November 22, 1999 RFA: DA-01-001 National Institute on Drug Abuse Letter of Intent Receipt Date: May 15, 2000 Application Receipt Date: July 14, 2000 THIS REQUEST FOR APPLICATIONS (RFA) USES THE MODULAR GRANT AND JUST-IN- TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Drug Abuse (NIDA) invites applications in the area of cognitive science and cognitive neuroscience that have the potential of addressing issues related to drug abuse and addiction. The objective of this RFA is to stimulate cognitive science and cognitive neuroscience research that has the potential to advance our understanding of the causes, consequences, neuronal basis and treatment of drug abuse and addictive processes. Cognitive research is encouraged that is model-driven, and either (1) explores and delineates basic cognitive processes related to drug abuse and addiction and vulnerability to drug addiction, or (2) directly studies drug abuse and the effects of drugs on particular aspects of cognitive functions. Basic cognitive research does not need to be conducted in drug abusing populations or involve administration of drugs, but investigators would need to provide a clear statement indicating how proposed research might advance the understanding of drug use and addiction. Cognitive science research that involves clinical populations would also be appropriate under this RFA. The research relevant to this announcement involves human subjects, for information about cognitive neuroscience research involving animal studies contact Dr. Roger Brown, 301-443-6975, This RFA will support individual research project grants and competitive supplements to existing grants. Research proposals will be considered that encompass either cognitive or cognitive neuroscience approaches. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS- led national activity for setting priority areas. This RFA, Cognitive Approaches to Addictive Processes , is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of Healthy People 2000 at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Awards to foreign institutions under R-series awards are generally limited to 3 years. MECHANISM OF SUPPORT The mechanisms of support will include the investigator-initiated research project grant (R01), small grant (R03), and exploratory/developmental (R21) grant. In addition, competitive supplements to add a research component to an existing grant will be eligible. Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information and specific application procedures. For research in methods development, the R03 or R21 mechanisms are particularly appropriate. The exploratory/developmental (R21) grants are limited to 3 years and small grants (R03) are limited to 2 years. Both are non-renewable and limited in direct cost amount per year (R03, $50,000, R21, $100,000). The R03 mechanism is intended for newer, less experienced investigators, for investigators at institutions without well-developed research traditions and resources, or for experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific information on individual research mechanisms can be obtained from the NIDA home page at The competitive supplements will be reviewed in accordance with the National Institutes of Health (NIH) standard review procedures, i.e., peer review/Council review. Competitive supplement requests are to be submitted on the RFA receipt date. Support may be requested for a period of up to 5 years for R01 grants and shorter periods of time for the other mechanisms. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Modular budgeting procedures apply for grants up to $250,000 per year. See for further information about modular budgets. The anticipated award date is July 30, 2001. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Applications judged to be nonresponsive to the RFA will be returned to the applicant. FUNDS AVAILABLE It is anticipated that 10-12 awards may be funded in FY2001 at a total cost of $2 million. RESEARCH OBJECTIVES Background: Cognitive processes are likely to play an important role in vulnerability to drug addiction and in the addiction process itself. However, more cognitive science research is needed to address this complex public health problem. Drug addiction is a chronic relapsing disorder that has many characteristics, including a persistent desire or compulsion to use a drug, loss of control of drug intake, reduction in other important activities because of drug use, continued use despite knowledge of harm, marked tolerance, characteristic withdrawal symptoms, and increased negative emotional state or stress when the drug is unavailable. The process of becoming addicted to drugs often begins with non-compulsive or less frequent use, which, over time, can lead to compulsive uncontrollable drug taking. Relapse to drug use occurs following short or long periods of abstinence and may result from stress and/or re-exposure to environments previously associated with drug use. Individuals addicted to drugs often can, but also often fail, to report intense craving for an abused drug. A complex mix of developmental and genetic factors play a role in vulnerability to drug abuse. Acute drug administration alters brain activity, and persistent changes in brain function in response to chronic drug use may contribute to chronic drug use. Conceptual Basis and Rationale: For the most part, neuropsychological methods have been used to study drug effects on cognitive processes and have examined cognitive processes, such as executive function, that may be antecedents to drug use or the consequences of drug abuse and addiction. This approach has been, and will continue to be, valuable in furthering our understanding of the antecedents and consequences of drug abuse and addiction. However, relatively few studies in basic cognitive science or cognitive neuroscience have related their fundamental methods and models to the problem of drug abuse and addiction. This is despite the prominence of cognition in basic science and the fact that cognitive factors potentially play an important role in virtually every problem associated with drug abuse and addiction. This RFA underscores NIDA’s appreciation that basic cognitive science and cognitive neuroscience methods, models, and approaches should provide new directions and innovative ideas for understanding fundamental problems associated with drug abuse and addiction. Fundamental cognitive research into the organization and neuronal substrates of processes such as inhibitory functions, modulation of cognitive processes by emotion, decision-making, automatic and controlled information processing, ability to monitor and evaluate ongoing cognitive performance, and acquisition (development) of cognitive skills are examples of the types of research that are relevant for appreciating conditions that promote, maintain, and may be involved in drug abuse and addiction and its treatment. It is likely that new and innovative basic cognitive research in these and other domains will inform and enhance our understanding of drug abuse and addiction and its neuronal substrates. At the same time, cognitive science research that directly studies drug abusers and related clinical populations, or studies the effects of drugs of abuse on cognitive processes, can continue to make important contributions to understanding this complex problem. One of the major goals of this RFA, therefore, is to invite research applications in basic cognitive research relevant to drug abuse and addiction. Basic cognitive science research that uses model-driven experimental cognitive science approaches to problems identified by investigators as being potentially relevant to issues of drug abuse and addiction (examples of such problems are listed below) is encouraged. Such research would capitalize on the rapid advances that have been made concerning the functional and neurobiological determinants of both simple and complex cognitive operations. In the context of this RFA, model-driven research implies the use of an experimental approach intended to test the operation of specific cognitive processes through systematic use of control conditions to rule out alternative interpretations. Applications that employ either functional or neuroscience approaches to cognitive processes are appropriate for this RFA. This research does not need to be conducted in drug abusing populations or involve administration of drugs, it but does need to address its potential for advancing the understanding of drug abuse and addiction. In addition, the research could be exploratory in nature in its attempt to better understand basic cognitive processes and with regard to its potential application to drug abuse and addiction. In such cases, applicants should provide a clear statement as to the relevance of the research to drug abuse and addiction. A second goal of this RFA is to invite research applications that can be directly applied to problems associated with drug abuse and addiction including studies of individuals at risk for addiction, consequences of drug abuse, and treatment. Knowledge gained from this research could be directly applied to the development and refinement of treatment and prevention interventions. The following are illustrative examples of the intersection of basic cognitive research topics with issues relevant to drug use and addiction. Cognitive neuroscience research that addresses the neural functioning that subserves these cognitive processes is especially appropriate for this RFA. These examples are intended as a guide and are not meant to subsume or limit the cognitive science research themes that would be appropriate and welcome under this RFA: o Study of modulation of cognitive processes by emotion and motivation. (This broadly defined research theme is central to nearly all aspects of addiction, as well as issues of co-morbidity with other disorders.) o Development of mathematical or computational models of cognitive processes. (Such models, particularly those that incorporate modulation by motivational/emotional states, are relevant and may provide new insights into many aspects of drug abuse and addiction.) o Basic studies of decision-making processes under conditions of risk, uncertainty and high motivational states. (Risk-taking and decision-making are relevant to addiction vulnerability and medical consequences of drug use such as risky sexual behavior and exposure to HIV). o Basic research on top-down and bottom-up control of attention and allocation of cognitive resources. (This research is likely to be relevant to cue-related drug craving and its relation to relapse). o Study of inhibitory functions, especially with respect to suppression of prepotent or conflicting responses, as well as metacognition and operations that subserve the ability to evaluate and monitor ongoing cognitive performance. (Such research has wide relevance to issues of drug abuse, addiction, and treatment since impaired inhibition and monitoring functions are seen as important for understanding craving and relapse.) o Study of cognitive mechanisms that control the transition to and from automatic and controlled information processing. (For example, this type of research is directly relevant to understanding drug craving, drug abuse relapse, and treatment). o Basic studies of cognitive mechanisms that play a role in the ability to monitor and evaluate ongoing cognitive performance. (This is particularly relevant to many issues concerning self-regulation and drug craving.) o Study of the acquisition (development) of cognitive skills, such as, inhibition, evaluative functions, and ability to plan and strategically allocate cognitive resources. (Knowledge gained from this research may be particularly important in delineating the types of cognitive skills that may serve to protect youth from vulnerability for drug abuse.) In addition, the following are illustrative examples of cognitive research topics that are directly related to problems of drug use and addiction. Again, these examples are intended as a guide and are not meant to subsume or limit the research themes that would be appropriate and welcome under this RFA: o Studies of acute and chronic drug-induced alterations in cognitive processes. (Such applied cognitive research may provide important new information about: the reward properties of abused drugs, facets of executive functioning, or impaired cognitive functioning that increases risk-taking behavior). o Characterization of cognitive processes and effects of drugs of abuse and HIV/AIDS progression, and explore and evaluate the effects of treatment procedures on reversing these deficits. o Assessment of the effects of prenatal exposure to drugs of abuse, and/or drug abuse pharmacotherapies on postnatal and cognitive performance and development. o Studies of brain processes that underlie any of the above topics or other cognitive functions that constitute innovative approaches to problems in drug use and addiction. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale or justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the Federal Register on March 28, 1994 (FR 59 14508- 14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at: NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA’s Home Page at or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit by May 15, 2000 a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. In addition, the letter of intent should identify other "key personnel" whom will be involved in the research and their institutions. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIH staff to estimate the potential review workload and to plan for the review of the applications. The letter of intent is to be sent to program official at the address listed under INQUIRIES. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone (301) 710-0267, E-mail: SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See for sample pages.) At the top of the page, enter the total Direct Costs requested for each year. This is not a Form page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: - Complete the educational block at the top of the Form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications, with full citations. CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title and number of this RFA must be typed in Item 2 on the face page of the application form, and the YES box must be marked. The sample RFA label available at: has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Applications must be received by July 14, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Research (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS This RFA invites applications from investigators who have not typically conducted drug abuse research. Therefore, reviewers will not expect applicants to have publications or training in the substance abuse area. Since exploratory research is encouraged, preliminary data may not be provided in the application. In such cases, reviewers will assess innovation, creativity, and related factors as described below. Applications that are complete will be evaluated for scientific and technical merit by a peer review group convened by NIDA in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIDA National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. (1) Significance: Are the goals and objectives of this application relevant to this RFA? Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Additional Specific Review Criteria The following section expands upon the above review criteria. Since the objective of this proposal is to invite research applications for an area currently not well represented within NIDA, the significance of the proposals and the qualifications of the applicants will be evaluated with respect to the potential for the studies to contribute to the mission of NIDA, broadly defined, rather than explicit expertise in substance abuse research or inclusion of substance abuse populations. In addition, it is anticipated that many applications in whole or part will consist of exploratory research rather than proof of a well-established idea. Such exploratory research is highly relevant to this RFA and is strongly encouraged. Therefore, innovation will be given high priority in the review. Furthermore, there will be less emphasis on preliminary data with respect to highly innovative proposals. Although preliminary data should provide evidence that the applicant has the means and understanding to carry out the proposed studies, preliminary data does not necessarily have to provide a specific demonstration of the hypotheses to be tested. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: - The adequacy of plans to include both genders, minorities, and their subgroups, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. - The adequacy of plans to make data available to other investigators in a timely fashion. - The reasonableness of the proposed budget and duration in relation to the proposed research. - The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. - The adequacy of plans for including children as appropriate for the scientific goals of the research. Schedule: Letter of Intent: May 15, 2000 Application Receipt Date: July 14, 2000 Council Review: February 20001 Earliest Start Date: April 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit as determined by peer review, availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Steven Grant, Ph.D. Cognitive Neuroscience of Addiction Program Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Blvd. Rm. 4234, MSC 9559 Bethesda, MD 20892-9559 Telephone: (301) 443-4877 FAX: (301) 443-6814 E-mail: Herbert Weingartner, Ph.D. Behavioral Sciences Branch Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Blvd., Room 4258, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 443-1263 FAX: (301) 594-6043 E-mail: Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Blvd., Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX : (301) 594-6847 E-mail: Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Director Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone : (301) 443-2755 FAX: (301) 443-0538 E-mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and are administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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