and Human Services (HHS)
EXPIRED
ROLE OF TOBACCO DEPENDENCE IN ALCOHOLISM TREATMENT RELEASE DATE: February 14, 2002 PA NUMBER: PA-02-064 EXPIRATION DATE: February 5, 2005 unless reissued. PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations o References PURPOSE OF THIS PA The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications to study the alcohol tobacco interaction in its implications for alcoholism treatment. The objective of this program announcement is to encourage research that will lead to improved strategies for treating alcohol and nicotine dependence in patients receiving care for problem drinking. Such research may identify and test relevant clinical intervention strategies, identify interactions between the two substances that have implications for relapse prevention, or further understanding of the alcoholism treatment process by investigating reinforcement mechanisms underlying conjoint abuse of the two substances. RESEARCH OBJECTIVES During the past decade many lines of converging data have suggested that alcohol and tobacco consumption are correlated. For example, smokers consume two times as much alcohol per capita as do non-smokers (Carmody et al., 1985) and their risk of excessive drinking is also twice that of non-smokers, a relationship that holds across a broad range of demographic variables (Henningfield et al., 1990, Johnson and Jennison, 1992). Alcoholism itself is estimated as 10 to 14 times more prevalent among those who smoke than those who do not (DiFranza and Guerrera, 1990). In addition, heavy drinking tends to be associated with heavy smoking with 85 percent of currently drinking alcoholics smoking daily. Although smoking has substantially declined in the United States to approximately 30 percent of adults, it has diminished very little among alcoholics. Co-occurrence of smoking and excessive drinking has important treatment implications. For example, previous or current problems with alcohol and alcohol treatment bodes negatively for success in smoking cessation (Bobo et al., 1987, DiFranza and Guerrera, 1990, Sandor, 1991). On the other hand, smoking cessation prior to formal alcoholism treatment (Miller et al., 1983) appears to improve subsequent drinking outcome. Conversely, reducing drinking appears to improve the prospects for successful smoking cessation (Burling et al., 1982). Curiously, participation in a stop-smoking program conducted during the course of alcoholism treatment was found to enhance maintenance of sobriety, even though the intervention had little impact on smoking behavior itself (Burling et al., 1991). Discontinuation of smoking and long-term abstinence from drinking are also associated. Alcoholics who maintain sobriety longer have been reported as more successful in smoking cessation (Bobo et al., 1987, Hughes, 1993). Similarly, relapse to drinking may prompt smoking relapse (Shiffman et al., 1985, Sees and Clark, 1993). Several pharmacologic and behavioral mechanisms have been proposed to explain the association between smoking and drinking. At a pharmacologic level some degree of cross-tolerance seems to occur between nicotine and alcohol as sympathetic nervous system agents, each of which has both depressant and stimulant effects. Second, conjoint use of the two substances may also be due to accelerated metabolism of one substance following ingestion of the other. Third, nicotine and alcohol may somewhat counteract the aversive effects of each other, while potentiating reinforcing effects. Specific Areas of Interest The following list of topics is intended only to illustrate NIAAA interests, topics not specified should not be viewed as excluded from consideration. The primary objective of this program announcement is to enhance the efficacy of treatment for nicotine dependent, alcohol-dependent patients. To that end, research studies are solicited in the following areas. Research is needed to determine the conditions under which tobacco use serves as a salient risk factor for alcohol relapse. Research suggests several hypothesized mechanisms for the linkage in conjoint alcohol-tobacco use. Studies are needed to more clearly specify these putative mechanisms and understand their interactions. Studies are needed which identify the optimal sequencing of alcohol and smoking cessation in treatment programs. Studies are needed which investigate the use of new/existing pharmacologic agents as adjuncts to alcohol and smoking cessation and in the maintenance of abstinence. Research is needed which elucidates factors that underlie the joint vulnerability to alcohol and nicotine dependence. Research is needed to develop common assessment methodologies for alcohol and tobacco dependence which will lead to improved treatment efficacy. Studies are needed which clarify the nature of the discriminative stimuli for alcohol and nicotine and how these stimuli interact. Studies are needed to determine whether conditioned cues associated with smoking enhance alcohol reinforcement. MECHANISM(S) OF SUPPORT This PA will use the NIH research project grant (R01) small grant (R03) and Exploratory/developmental grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for a research project grant (R01) application submitted in response to this Program Announcement may not exceed 5 years. Exploratory/developmental grants (R21) are limited to 3 years for up to $100,000/year for direct costs. (See Program Announcement PA-99-131, "NIAAA Exploratory/Developmental Grant Program," http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html, for a complete description of the R21 mechanism.) Under the NIAAA Small Grant mechanism (R03) applicants may request either $25,000 or $50,000 in direct costs per year for up to two years. These awards are not renewable, however, a no-cost extension of up to one year may be granted to the grantee institution prior to expiration of the project period. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01). (See Program Announcement PA-99-098, "NIAAA Small Grant Program," http://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html, for a complete description of the R03 mechanism.) This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: Joanne B. Fertig, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulvard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 For express mail use: Rockville, MD 20852) Telephone: (301) 443-0635 Fax: (301) 443-8774 Email: [email protected] o Direct your questions about financial or grants management matters to: Judy Fox Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulvard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 (For express mail use: Rockville, MD 20852) Telephone: (301) 43-2434 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIAAA staff member who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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 REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.273, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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. REFERENCES Burling, T.A., Marshall, G.D. & Seidner, A.L. (1991). Smoking cessation for substance abuse inpatients. J Subst Abuse, 3(3), 269-276. Burling, T.A., Stitzer, M.L., Bigelow, G.E. & Russ, N.W. (1982). Techniques used by smokers during contingency motivated smoking reduction. Addict Behav, 7(4), 397-401. Carmody, T.P., Brischetto, C.S., Matarazzo, J.D., O"Donnell, R.P. & Connor, W.E. (1985). Co-occurrent use of cigarettes, alcohol, and coffee in healthy, community-living men and women. Health Psychol, 4(4), 323-335. DiFranza, J.R. & Guerrera, M.P. (1990). Alcoholism and smoking. J Stud Alcohol, 51(2), 130-135. Henningfield, J.E. Clayton, R. & Pollin, W. (1990). Involvement of tobacco in alcoholism and illicit drug use. Br J Addict, 85(2), 279-291. Hughes, J.R. & Oliveto, A.H. (1993). Coffee and alcohol intake as predictors of smoking cessation an tobacco withdrawal. J Subst Abuse, 5(3), 305-310. Johnson, K.A. & Jennison, K.M. (1992). The drinking-smoking syndrome and social context. Int J Addict 27(7), 749-792. Sees, K.L. & Clark, H.W. (1993). When to begin smoking cessation in substance abusers. J Subst Abuse Treat, 10(2), 189-195.
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NIH Funding Opportunities and Notices
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