PA-98-106: PATHOLOGICAL GAMBLING: BASIC, CLINICAL AND SERVICES RESEARCH

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

PATHOLOGICAL GAMBLING: BASIC, CLINICAL AND SERVICES RESEARCH Release Date: September 16, 1998 PA NUMBER: PA-98-106 P.T. National Institute of Mental Health National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse Letter of Intent Receipt Date: October 19 Application Receipt Date: November 16 PURPOSE The three participating institutes of the National Institutes of Health (NIH) wish to encourage investigator-initiated research relevant to their programs that will advance basic, clinical and services research concerning pathological gambling, as well as enable more effective clinical assessment, prevention and treatment. This program announcement encourages research that builds on extant research findings concerning pathological gambling and research that expands the breadth and depth of scientific knowledge through increased involvement of various disciplines, e.g., epidemiology, genetics, neuroscience, developmental psychopathology, and behavioral, cognitive, and social science. Multidisciplinary research is especially encouraged. Major questions include: factors that predispose for pathological gambling and that distinguish types of pathological gamblers, models for explaining pathological gambling, e.g., social learning, addiction, impulse dyscontrol, developmental pathways and course, gender, age, and socio-cultural factors, mechanisms involved in onset, continuation, and cessation, efficacious clinical interventions for the prevention of onset, for treatment, and for prevention and management of relapse, effectiveness of interventions in general use, and effects of the organization and financing of services. 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 PA, Pathological Gambling Basic, Clinical and Services Research, is related to priority areas of mental health and mental disorders, drug abuse and addiction, and alcohol abuse and alcoholism. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, 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. MECHANISM OF SUPPORT Research Project Grant (R01) applications may be submitted in response to this program announcement. R01 applications may request up to five years of support. Responsibility for the planning, direction, and execution of the proposed project will be solely the responsibility of the applicant. RESEARCH OBJECTIVES Summary For many persons, gambling is an interesting and enjoyable activity, with no or minimal adverse effects on their finances, work, or relationships with family members and others. However, for some persons, gambling becomes seriously maladaptive and results in major financial losses, interferes with work, and disrupts relationships with family and others. This type of maladaptive behavior is sometimes referred to as pathological gambling. What explains such "out of control", dysfunctional and injurious behavior? Is pathological gambling behavior primarily a reflection of another disorder (e.g., depression) or a non-pharmacological addiction, a result of social- cognitive factors (e.g., faulty cognitions and reinforcement schedules), or a reflection of other factors? What are the predisposing factors? Are there different types of pathological gamblers for which different models are required to explain their gambling? Once such gambling occurs, what is its life course and what factors influence that course? To what extent, and in what ways, is alcohol and drug use concurrent with pathological gambling? In these cases, is the pathological gambling and substance abuse a reflection of common or different factors, and what are the nature and interactive effects of pathological gambling and substance abuse? How prevalent is pathological gambling? How is it defined? What are the reliability and validity of various definitions? What strategies are most effective for preventing pathological gambling? For pathological gamblers, what treatments are effective for this behavior and for co-occurring disorders and problems, e.g., the risk of suicide? What treatment models are effective for preventing and managing relapse and related problems? What is the effectiveness of treatments delivered in clinical and community settings? Applications are encouraged that build on extant research findings concerning pathological gambling, and also that involve a number of disciplines and methods in order to produce broad and deep scientific knowledge. The extant research concerning pathological gambling suggests a number of possibilities for research. For example, several pharmacological and psychosocial interventions have shown promise in preliminary studies. Development of rigorous efficacy studies, with participants of diverse backgrounds, assessment of intervention effects on mediators or mechanisms presumed to underlie pathological gambling, and extended and comprehensive follow up, could contribute both to better informed clinical practice and basic scientific understanding of factors that account for pathological gambling. Multiple disciplines have potentially important contributions to make to a comprehensive understanding of pathological gambling. For example, brain imaging enables new views of the involvement of the brain in various disorders and addictions. How is the brain involved in the development and course of pathological gambling? How is this involvement similar to the nature of the involvement of the brain in disorders of addiction, compulsive behavior, and impulse dyscontrol? In addition, alcohol and other drug abuse is often co-current with pathological gambling and may be related in a number of ways. These two pathological behaviors may be related to a common underlying etiological process or the comorbidity may relate in a reinforcing fashion. The study of the relationship, similarities and differences of these behaviors may not only give important information about comorbid patterns but may also help illuminate the nature of the pathologies as distinct patterns of behavior. Other research possibilities are indicated below. These are not prescriptive or exclusive, the goal of this announcement is to encourage investigator-initiated research that, by its creativity and scientific merit, will most efficiently and effectively advance basic, clinical and services research concerning pathological gambling. Suggested Research topics: Basic, epidemiological and life course research: o Animal studies of potentially relevant models, processes and behaviors, e.g., addiction, impulsivity, reinforcement schedules. o Identification of factors that influence the accuracy of self reports and informant reports in surveys and clinical assessments about the nature, extent and consequences of gambling episodes, and the use of these findings to develop procedures to obtain maximally accurate information. o Family studies of the disorders and dysfunctional behaviors of pathological gamblers. o Family genetic and neuroimaging studies of pathological gamblers. o Determination of factors (genetic, developmental, neuroscience, cognitive, sociocultural, stable personality characteristics, etc.) associated with the initiation and course of gambling and its escalation or cessation across gender, age, SES, culture and ethnicity. o Studies of the effects of public policies and the availability of gambling opportunities on the onset and course of individual pathological gambling behavior (e.g., the effects of legalization of casinos and the availability and conditions of service of alcohol). o Investigations of patterns of comorbidity of drug and alcohol abuse and pathological gambling. o Investigations of pathological gambling as a non-pharmacological model of addictive/compulsive behaviors. o Comparison of pathological gambling with disorders that may involve similar factors and mechanisms, e.g., addictions, compulsions, and impulse dyscontrol. o The role of pre-existing disorders, dysfunctional behaviors and disease in the development and course of pathological gambling. o Factors associated with the emergence of comorbid disorders among pathological gamblers. o The life course of pathological gamblers and the factors associated with variation in gambling and other measures of functioning. Clinical research: o Testing and refinement of the DSM definition of pathological gambling to achieve a construct of high reliability and validity. o Empirical determination of different types of pathological gamblers, e.g., by type of gambling, comorbid disorders, distinguishing neuroscience and cognitive factors. o Identification of biological, neuroscience, cognitive, affective, sociocultural and environmental mechanisms that contribute to treatment responsivity or resistance. o Development of science-based and theory-driven pharmacological and psychosocial interventions to prevent or treat pathological gambling, and to prevent and manage relapse and associated disorders and problems, including mood disorders, impulsivity, and alcohol and drug abuse. o Determination of the mechanisms of action in interventions. o Rigorous efficacy trials of interventions to prevent either the onset and relapse, as well as to treat pathological gambling. o Research on the effective sequencing of interventions, including interventions for comorbid disorders and problems. o Development of procedures to enhance entrance into, continuation and active engagement in prevention, treatment, and in relapse prevention and management. Services research: o Factors that contribute to, and militate against, help-seeking behaviors among pathological gamblers. o Examination of the settings in which pathological gamblers receive treatment, and the effectiveness of the service systems in identifying and treating pathological gambling, particularly when it occurs with other comorbid mental and substance abuse conditions. o Analysis of the effects of variations in the organization and financing of care on the access to and type of treatment programs that pathological gamblers enter and on the nature and extent of treatment. o Evaluation of the effectiveness of generally used treatments for pathological gamblers such as Gamblers Anonymous. o Evaluation of health-related costs and benefits of legalized gambling in a jurisdiction (e.g., health-related costs such as changes in rates of psychiatric service utilization, suicide and self-inflicted injuries, social costs such as divorce and families in poverty, additional jobs and increased family income). 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 and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This 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," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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: http://www.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by October 19, a letter of intent that includes a descriptive title of the proposed research, the name, mail and Email address, and the telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this program announcement. Such letters are requested only for the purpose of facilitating technical assistance and review by providing an indication of the number and scope of applications likely to be received. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: James Breiling, Ph.D. Division of Mental Disorders, Behavior and AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857-0001 Telephone: (301) 443-3527 FAX: (301) 443-4611 Email: jbreilin@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). 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, fax: (301) 480-0525 Email: GrantsInfo@NIH.GOV. The title and number of the program announcement must be typed in Section 2 on the face page of the application. The completed original application and five legible copies must be sent or delivered 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) Applications will be accepted in response the this PA on November 16 of each year. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. An appropriate peer review group convened in accordance with the standard NIH peer review procedures will evaluate applications that are complete for scientific and technical merit. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our 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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance. 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? The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women, Children and Adolescents and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding scientific and programmatic issues to: James Breiling, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 5600 Fishers Lane, Room 18C-14 Rockville, MD 20857-0001 Telephone: (301) 443-3527 FAX: (301) 443-1611 Email: jbreilin@nih.gov Darryl Bertolucci, M.A. Epidemiology Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 514, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4898 FAX: (301) 443-8614 Email: db46e@nih.gov Meyer D. Glantz, Ph.D. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-53 Rockville, MD 20857 Telephone: (301) 443-2974 FAX: (301) 443-2636 Email: mg115g@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857-0001 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Edward Ellis Grants Management Branch National Institute of Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4706 FAX: (301) 443-3891 Email: eellis@willco.niaaa.nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242, 93.273, and 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 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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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