Full Text PA-95-055 RESEARCH ON COMORBID MENTAL AND DRUG ABUSE DISORDERS NIH GUIDE, Volume 24, Number 15, April 28, 1995 PA NUMBER: PA-95-055 P.T. 34 Keywords: Mental Disorders Drugs/Drug Abuse Etiology AIDS Disease Prevention+ National Institute on Drug Abuse National Institute of Mental Health PURPOSE The purpose of this program announcement is to encourage research on comorbid mental and drug abuse disorders. One aim of this research program is to explore and identify etiological and neurobiological factors that are associated with the co-occurrence of drug abuse/addiction and mental disorders. A second aim is to develop new treatment and prevention interventions for the population afflicted with these disorders. A third aim is to develop effective strategies and procedures for managing the impact of HIV/AIDS on individuals with comorbid mental and addictive disorders and the impact of comorbid mental and addictive disorders on persons with HIV/AIDS. A fourth aim is to assess existing drug abuse and mental health treatment interventions and services for persons with mental and addictive disorders. 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 Program Announcement, Research on Comorbid Mental and Drug Abuse Disorders, is primarily related to the priority area of alcohol and other drugs. 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 202-783-3238). 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 or 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. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. MECHANISM OF SUPPORT The mechanisms available for support of this program announcement are the regular research project grant (R01), the small grant (R03), the FIRST award (R29), and the clinical cooperative grant (R10). Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will vary also. RESEARCH OBJECTIVES Background Research has suggested that comorbidity of drug addiction with mental disorders may have prognostic value and important implications for the prevention and treatment of drug dependence. Drugs of abuse and addiction may precipitate or exacerbate mental disorders; self- medication for mental disorders may result in drug abuse or addiction. The forms of comorbidity may be influenced by the class of drug abused, the duration of drug use, individual sensitivity to drug effects and whether the drug effects are acute, or due to withdrawal or residual conditions. Knowledge of comorbid disorders is important because it can enable prevention and treatment services to be appropriately configured and designed for clinical populations. The etiology of drug abuse and addiction has been shown to be complex and multifactorial and influenced by environmental and constitutional factors. Increased knowledge of factors influencing drug abuse/addiction and comorbid mental conditions will be helpful for patient-treatment matching and maximizing the effectiveness of available treatment interventions and services. The importance of a greater focus upon comorbid mental and addictive disorders is underscored by research studies that suggest there is a greatly increased risk for substance use disorder for individuals with various mental disorders compared to those without. Programs that focus on drug abuse and dependence and programs that focus on mental disorders tend not to be integrated with one another and, in general, tend not to make HIV-related issues a primary focus. Psychiatric symptoms and drug use are associated with increased HIV risk behaviors. This is true in both treatment populations and out- of-treatment populations. Clinical studies suggest that people who have a history of comorbid mental and addictive disorders, when treated for drug addiction, tend to relapse at a greater rate than those without a history of mental disorder. Interventions for the mental disorder appear to reduce the relapse rate of these individuals. These findings suggest that treatment of a comorbid mental condition may prove to be crucial to effective drug abuse treatment in populations with concurrent mental and addictive disorders. It is worth noting that AIDS is a major co-occurring condition among drug users in the USA. Injection drug users are the second largest group of persons with AIDS in this country. Male injection drug users who also have sex with men are an important subgroup of injectors with AIDS, accounting for approximately 20 percent of these cases. Also, the majority of cases of AIDS attributed to heterosexual transmission, were sexual partners of drug users. Moreover, more than 50 percent of children with AIDS were the offspring of mothers who either abused drugs or were sexual partners of persons who did. Clearly, drug abuse treatment programs and HIV/AIDS treatment facilities need to treat both drug dependence and AIDS-related complications, including resulting mental health conditions such as depressive and anxiety disorders. Research is encouraged on HIV/AIDS disease issues, including transmission, disease progression, risk-behavior change and treatment, in drug abusing populations with comorbid mental disorders. A number of studies show that psychiatric comorbidity, including both diagnosable conditions and subsyndromal levels of psychiatric symptomatology, is associated with difficulties in retention in drug abuse treatment and that non-entry to or drop- out from treatment is associated with higher levels of risk behavior and higher HIV seroconversion rates. Other studies suggest lower levels of adherence to medical regimens and risk reduction recommendations among drug abusers with comorbid mental disorders. Moreover, studies suggest increased rates of depression in HIV seropositive drug abusing populations that appear to be directly associated with stage of HIV disease. In this context, the interaction of HIV issues with comorbid mental conditions in drug abusing populations requires further exploration in terms of (1) describing the changes in risk for morbidity and mortality related to these comorbid mental conditions and (2) elucidating the mechanisms underlying the effects of these comorbidities on risk, with the objective of designing effective prevention and treatment strategies. Description of Program Studies under this program announcement may focus on the etiology, prevention, treatment, and neurobiology of comorbid mental and addictive disorders. Neurobiological studies may involve neuroimaging (e.g., MRI, CT, PET, SPECT, and EEG). Treatment research studies may focus on the development, piloting and efficacy testing of therapeutic interventions. Prevention studies may focus upon testing theory-based preventive interventions focused on reducing the risk of onset and progression of comorbid conditions prior to clinical diagnosis. Services research studies are also appropriate under this program announcement, and may involve analyses of existing treatment data bases, collection of new data, including effectiveness studies of strategies for improving services to comorbid populations. Studies may be based in a variety of public and private settings (e.g., hospitals, residential programs, outpatient programs, community based programs, primary care settings, correctional settings) and may involve a variety of treatment or non-treatment populations. The use of multiple outcome domains (e.g., work performance) as criterion variables is encouraged. Subpopulations of children, adolescents, women, minorities, persons in correctional and parole settings, homeless persons with serious mental illnesses and drug abuse/addictive disorders, and the elderly experiencing comorbid mental and addictive disorders are of particular interest. Examples of Research Topics Research topics might include, but are not limited to, the following: Studies involving neuroimaging of individuals with comorbid mental and addictive disorders to expose evolving neural substrates of behavior. Studies of drug induced neuropsychological deficits in comorbid mental and addictive disordered populations. Assessment of these deficits and their relationship to therapeutic efficacy may be also studied. Studies of etiological and neurobiological factors that underlie the co-occurrence of drug abuse/addiction and mental disorders. Cohort studies of high risk groups ( e.g., children in high drug abuse areas, children of drug abusers, children of individuals with mental disorders, elderly or homeless persons with serious mental illnesses and drug abuse/addictive disorders) to assess potential risk factors for the co-occurrence of drug abuse/addiction and mental disorders. In addition, data on patterns of symptoms, levels of impairments, help-seeking behaviors, and treatment history are needed. Pharmacological interventions alone and in combination with behavioral approaches may be examined. Protocols may be developed for detoxification, maintenance, and relapse prevention for specific drugs of abuse when other comorbid conditions are present. Drug- medication, medication-medication, and medication-disease interactions may be examined when pharmacotherapy is prescribed for one or both of the addictive or mental disorders, as well as HIV/AIDS. Behavioral therapies (e.g., cognitive therapy, psychotherapy, family therapy, counseling, motivational interventions) to treat clients diagnosed with a drug use disorder plus one or more other co- occurring mental disorder may be developed and piloted. Fully developed therapies may be tested for efficacy. Behavioral interventions may also be developed, piloted and tested to prevent comorbid conditions prior to clinical diagnosis. Approaches to minimize the harm associated with drug addiction and comorbid mental disorders, including both pharmacological and behavioral interventions, may be developed and piloted and tested for efficacy. The developmental stage of the child or adolescent with or at risk for comorbid mental and addictive disorders is an important prevention and treatment consideration. The development, piloting, and efficacy testing of preventive interventions and treatment protocols specifically designed for children and adolescents at particular developmental stages is needed. Studies involving course and temporal relationships of illness as individuals move from having a single disorder to comorbid disorders. Such studies can be clinical or epidemiological in design. The effect of treatment can be used to observe change in course, severity and impairment among the multiple disorders studied. Specific financing and reimbursement policies, and cost- and utilization-management strategies, and effects of resource/funding limitations on aspects of prevention and treatment service delivery and subsequent outcomes for populations afflicted with comorbid mental and addictive disorders may be studied. Also of interest are questions regarding the effect of service delivery system variables (e.g. organizational structure and environment, management and treatment practices and philosophy, staffing patterns, and clinical training and expertise of drug abuse and mental health providers) on treatment outcome in these populations. Studies assessing the prevention and treatment needs in this population and the relationship of need to demand, access, and service utilization. In addition, studies to test assessment strategies and interventions to overcome barriers to access to and utilization of services. Integration of models for delivery of drug abuse and mental health services for clients with a drug use disorder and a comorbid mental disorder warrant further study. Innovative approaches to prevention, outreach, client assessment, case management, assertive community treatment, managed care, family treatment and systems-of-referral among available service providers may be studied with the aim of increasing enrollment in and decreasing early withdrawal from treatment. A particular area of interest is the development of appropriate referral systems between drug abuse/addiction and mental health providers. Therapeutic environments such as psychiatric outpatient, inpatient, short-and long-term residential programs, as well as hospitals, primary care clinics, social service agencies, and correctional facilities may be evaluated for their effectiveness for clients with specific comorbid conditions. Impact of comorbid mental and addictive disorders on HIV/AIDS requires research to address linkage of services, continuity of care, service utilization management, matching services to client needs, financing/cost constraints, and cost effectiveness and cost-benefits. In addition, studies of the effects of disconnections of services between mental health and drug abuse populations and also, drug abuse populations and homeless programs are of interest. Development of AIDS prevention/intervention techniques that maximize adherence to risk reduction and prophylactic regimens across changes in cognitive, emotional, and physical state related to drug abuse, fluctuating psychiatric status and HIV disease stage. These could include the development of intervention approaches to change behaviors of persons seen in primary care, drug abuse treatment or mental health settings, or through community outreach. In addition, studies that examine the role of cognitive dysfunction and poor psychosocial functioning on the development of drug abuse, mental disorders and HIV infection are of interest. Genetic epidemiologic research is needed to examine rates of mental and drug abuse/addiction disorders in families to assess whether comorbidity is attributable to a causal mechanism between the co- occurring mental and drug abuse/addictive disorders or if each disorder is a manifestation of similar underlying factors (genetic, environmental, or a combination). Case-control studies of biological, familial, or psychological factors that distinguish those with both mental and drug abuse/addictive disorders, those with either disorder alone, and those with neither disorder. Research into the development of statistical methods for the analysis of the transmission of co-occurring mental and drug abuse/addictive disorders. Development of clinical instruments to conduct broad-based behavioral/environmental assessments of risk for HIV and associated illnesses, e.g., tuberculosis, in comorbid mental disordered populations of drug abusers. In addition, clinical instruments should be developed using novel dimensional, non-DSM IV, assessments as well as brief methods of identification and assessment for field trials. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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 reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of the program announcement must be typed in Item 2a of face page of the application. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST (R29) award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications that are complete and responsive to the program announcement will be reviewed for scientific and technical merit by a peer review group convened 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 applications under receive, will be discussed, assigned a priority score and receive a second level review by the appropriate national advisory council. R03 applications do not receive a second-level review. Review Criteria o scientific, technical, or clinical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequancy of plans to include both genders and 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 initial review group will also examine the provisions for the protection of human and animals subjects, and the safety of the research environment. 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 programmatic issues to: Arthur MacNeill Horton, Jr., Ed.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-46 Rockville, MD 20857 Telephone: (301) 443-6697 Email: ah61x@nih.gov Kathryn M. Magruder, M.P.H., Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 Email: kmagrude@aoamh2.ssw.dhhs.gov Direct inquires regarding fiscal issues to: 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 Email: gf6s@nih.gov Bruce Ringler Grants Management Branch National Institute of Mental health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-2065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of Section 301 of the Public Health Service Act (42 USC 241) and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 and 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Sections of the Code of Federal Regulations are available in booklet form from the U.S. Government Printing Office. Grants must be administered in accordance with the PHS Grants Policy Statement, (rev. 10/90), which may be available from your office of sponsored research. .
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