This Program Announcement expires on October 5, 2004, unless renewed. ADVANCEMENT OF BEHAVIORAL THERAPIES FOR ALCOHOLISM TREATMENT Release Date: October 11, 2001 PA NUMBER: PA-02-012 National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications on the clinical use of behavioral therapies for alcoholism treatment. The term behavioral therapy is used broadly to include a range of nonpharmacological therapies including cognitive-behavioral therapy, motivational enhancement therapy, twelve-step facilitation, marital and family therapy, community-reinforcement approach, contingency management, and brief intervention. To further advance the field of behavioral therapies, several research areas have been identified and include developing new innovative therapies, creating or refining behavioral techniques for the engagement, retention, and adherence of patients in treatment, developing therapies to manage precipitants of relapse, investigating the effectiveness of behavioral therapies in group settings, and combining and sequencing of behavioral and pharmacological treatments. It is recommended that the development and formulation of new therapies or the refinement of existing therapies be first tested as small-scale pilot studies prior to conducting clinical efficacy trials. All applications submitted in response to this program announcement should be conducted in humans. 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 Program Announcement (PA) is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" 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. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), exploratory/developmental grant (R21), and small grant (R03)award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five (5) years. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. More detailed information on the R21 mechanism can be found at Applications requesting direct costs of $500,000 or more in any one year must obtain written agreement from the NIAAA that the application will be accepted for consideration of award, in accordance with NIH policy, which is available at Currently, small grants (R03) are limited to 2 years for up to $50,000 per year for direct costs, and exploratory/developmental grants (R21) are limited to $100,000 per year for direct costs for up to 3 years. Exploratory/developmental grants cannot be renewed: however, a no-cost extension of up to one year may be granted prior to expiration of the project period. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01). Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at RESEARCH OBJECTIVES Background Most of the treatments available in the U.S. for alcoholism have been behavioral in nature. A large number of clinical trials conducted over the past 15 years have demonstrated effectiveness for several types of behavioral therapies, including cognitive behavioral therapy, motivation enhancement therapy, marital family therapy, brief interventions, and community- reinforcement approach (Hester and Miller, 1995, Fuller and Hiller-Sturmhofel, 1999, National Institute on Alcohol Abuse and Alcoholism, 2000). Cognitive behavioral coping-skills therapy which aims to improve the patient’s skills for changing their problematic drinking behavior, has been successful in improving treatment outcome in alcoholic patients (Longabaugh and Morgenstern, 1999). Nonetheless, it has been suggested that its effectiveness can be increased by integrating it with components of other treatment approaches, such as motivational interviewing (Longabaugh and Morgenstern, 1999). This strategy is currently being implemented and tested by COMBINE, an ongoing 11-site randomized clinical trial, conducted as a cooperative agreement by NIAAA. Motivational enhancement therapy was developed in Project MATCH and involves strategies to motivate patients to stop or reduce their drinking. Surprisingly, motivational enhancement therapy proved nearly as effective as the more intensive cognitive behavioral and twelve-step facilitation therapies in reducing the frequency and amount of drinking in alcohol dependent patients (Project MATCH Research Group, 1998). Motivational interviewing, a component of the motivational enhancement therapy, also appears to aid engagement and retention of patients in treatment (DiClemente et al., 1999, Miller, 1995). Twelve-step facilitation interventions have been demonstrated to be effective in promoting abstinence and in increasing patient’s involvement in Alcoholics Anonymous (AA) programs (Humphreys, 1999). Results from Project MATCH showed that AA attendance was associated with more favorable treatment outcomes in all three therapies (Project MATCH Research Group, 1998). Brief interventions have been successful in reducing drinking levels in patients at risk for or experiencing alcohol-related problems (Fleming and Manwell, 1999, Wilk et al., 1997, Bien et al., 1993). The therapy consists of providing brief counseling to patients by a physician or nursing staff in five or less office visits. Marital family therapy appears helpful in enhancing treatment retention and improving drinking outcome. For example, behavioral couple therapy which employs a sobriety contract with the spouse, teaches marital communication, and emphasizes shared activities and positive feelings, increased abstinence and reduced couple separations and domestic violence (O Farrell and Fals- Stewart, 2000). The community reinforcement approach provides positive reinforcement for sobriety, eliminates reinforcers for drinking, and teaches new coping behavior. Studies have demonstrated that the community reinforcement approach is more successful in reducing drinking than traditional outpatient treatments (Miller et al., 1999). Integrating the community reinforcement approach with family therapy also appears promising (Smith et al., 2001). Contingency management encourages behavioral change in drinking by either presenting patients with positive reinforcements (e.g., money, vouchers, and prizes) for meeting treatment goals or employing adverse consequences when patients relapse to drinking (e.g., withholding of vouchers and writing an unfavorable report to a parole officer). Although contingency management has been successfully used to reduce illicit drug use, researchers have only recently applied this technique to alcoholism. So far, results have been positive in retaining alcohol dependent patients in treatment and in reducing their drinking behavior (Higgins and Petry, 1999). Finally, cue-exposure therapy involves exposing a patient to alcohol-related cues during therapy. Although few studies have investigated its effectiveness for alcoholism treatment, the results, so far, have been promising (Monti and Rohsenow, 1999). Thus, progress has been made in a broad range of behavioral interventions to treat alcohol abuse and dependence. Still, many alcoholics do not respond adequately to currently available behavioral therapies. The purpose of this program announcement is to improve the overall effectiveness of behavioral interventions in the engagement, retention, adherence, and outcome of alcoholism treatment across various populations of alcohol dependent and abuse subjects. Specific Areas of Interest Examples of research opportunities exist in the following areas: - New and innovative therapies. Since current alcoholism treatments have modest effects, new therapies and enhancement of existing therapies are needed. New therapies can be based on promising findings from basic behavioral and cognitive research, interventions found effective in changing other problematic behaviors, and theory-driven models of behavioral sciences. - Engagement and retention of patients in treatment. Treatment providers consistently state that, from their perspective, research improving retention should be the number one priority. A beginning has been made to develop promising behavioral techniques to engage reluctant/ambivalent patients in treatment using a motivational interviewing model. A behavioral technique that has shown promise in improving retention is contingency management. But further research is needed in this important area. - Patient compliance. Compliance has been shown to be a key determinant of outcome with medications, with relapse rates lower in those who comply with the prescribed regimen. At the same time, medical studies often report noncompliance to medication as a major problem, with as many as 50% of patients failing to take the medication as prescribed within the first few weeks of treatment. There is a critical need to develop practical, effective means to improve patient compliance. - Precipitants of relapse. Relapse to drinking is common after treatment. Patients have identified multiple precipitants of relapse including stress, social pressure, insomnia, anger, depression, anxiety, and environmental cues associated with prior drinking experiences. Better behavioral techniques to enable patients to manage these precipitants without resorting to drinking are needed to improve the long-term treatment of alcoholism. - Behavioral therapies in group settings. Group therapies are the most commonly used approach in the treatment of alcoholism. Little research, however, exists in this area, particularly on how group therapy compares with individual counseling. Behavioral dynamics and modeling of group sessions and evaluation of its effectiveness with subtypes of alcoholics in diverse treatment settings need to be investigated. Research from social psychology would be informative for studying group therapy. - Combinations and sequences of treatment. Current alcoholism treatments yield modest effects. By combining or sequencing treatments, it may be possible to enhance outcomes, particularly for nonresponders. Combined interventions can include behavioral therapies as broadly defined in this program announcement and pharmacotherapies. They might also be focused as tailored interventions for special populations (see below). - Natural resolution of alcohol problems. Many problem drinkers, particularly, those with mild to moderate severity, recover outside of the formal alcohol treatment system. Identifying the factors involved in natural resolutions might provide insight into structuring new effective behavioral interventions. - Special populations. In this program announcement, special populations refer to important, often understudied populations with special treatment needs, such as minorities, the elderly, and women, especially those who are pregnant. The following are examples of research topics relevant to four additional special populations: -- Alcohol abusing and dependent patients with co-occurring psychiatric disorders. Individuals with alcohol use disorders have high rates of co- occurring psychiatric comorbidity. Interestingly, this population is more likely to seek alcoholism treatment than noncomorbid alcoholics are but also more likely to drop out of treatment. In addition, the prognosis is generally poorer. Limited research has been conducted in the treatment of this population. In particular, research is needed to develop specialized behavioral therapies for comorbid patients. The effects of treating the concurrent disorders on alcoholism treatment outcomes also needs to be determined. The intervention strategy to address both the alcoholism and the psychiatric condition might depend on the kind of comorbidity and perhaps, the subtype of comorbid alcoholic patient. -- Develop effective interventions for adolescents with alcohol problems. Drinking as well as adverse alcohol-related consequences increase year by year as adolescents approach adulthood. Critical consequences of adolescent alcohol abuse include impaired social and academic functioning, psychiatric problems, and high-risk problem behaviors that include polydrug use and smoking. There is a clear need for behavioral interventions that specifically focus on the issues and problems of adolescence. Examples of behavioral therapies that may hold promise but require further research include cognitive behavioral therapy, motivation enhancement therapy, and family therapy. Optimal combinations and sequencing of behavioral and pharmacological interventions need to be investigated for the treatment of the more severely affected adolescents. -- Individuals with alcohol use disorders in the criminal justice system. Approximately 80 percent of the prison and jail inmates are involved in alcohol and drug use. Limited research, however, exists on understanding their behavioral complexities and appropriate treatment. -- Professional health care personnel suffering from alcohol use disorder. Little research currently exists on treating physicians, nurses, and other professional health care personnel who have a problem with alcohol. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines are available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: DATA AND SAFETY MONITORING PLAN As of the October 2000 receipt date, applicants must supply a general description of the Data and Safety Monitoring Plan for ALL clinical trials, this must be included in the application ( The degree of monitoring should be commensurate with risk. NIH Policy for Data and Safety Monitoring requires establishment of formal Data and Safety Monitoring Boards for multi-site clinical trials involving interventions that entail potential risk to the participants. The absence of this information will negatively affect your priority score. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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: 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at must be used in applying for these grants and will be accepted at the standard application deadlines ( as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of the original application as well as any subsequent revisions. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at Additional information about Modular Grants is also available on this site. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific 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 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. o The adequacy of the proposed plan to share data, if appropriate. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Cherry Lowman, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 executive Blvd. (MSC-7003) Bethesda, MD 20892-7003 (For express mail use: Rockville, MD 20852) Telephone: (301) 443-0637 FAX: (301)443-8774 Email: Direct inquiries regarding fiscal matters to: Judy Fox Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 executive Blvd. (MSC-7003) Bethesda, MD 20892-7003 (For express mail use: Rockville, MD 20852) Telephone: (301) 443-2434 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 and contract 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, and 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 Bien, T.H., Miller, W.R., & Tonigan, J.S. (1993) Brief interventions for alcohol problems: A review. Addiction 88:315-336 DiClemente, C.C., Bellino, L.E., & Neavins, T.M. (1999) Motivation for change and alcoholism treatment. Alcohol Research & Health 23:86-92. Fleming, M., & Manwell, J.B. (1999) Brief intervention in primary care settings. Alcohol Research & Health 23:128-137. Fuller, R.K., & Hiller-Sturmhofel, S. (1999) Alcoholism treatment in the United States: An overview. Alcohol Research & Health 23:69-77. Hester, R.K. and Miller, W.R. (1995) Handbook of Alcoholism Treatment Approaches, Second Edition, Boston: Allyn and Bacon. Higgins, S.T. and Petry, N.P. (1999) Contingency management: Incentives for sobriety. Alcohol Research & Health 23:122-127. Humphreys, K. (1999) Professional interventions that facilitate 12-step self- help group involvement. Alcohol Research & Health 23:93-98. Longabaugh, R., & Morgenstern, J. (1999) Current status and future directions. Alcohol Research & Health 23:79-85. Miller, W.R. (1995) Increasing motivation for change. In R.K. Hester & W.R. Miller (editors), Handbook of Alcoholism Treatment Approaches: Effective Alternatives, 2nd Edition, Needham Hights, Massachusetts: Allyn & Bacon, pp. 89-104. Miller, W.R., Meyers, R.J., & Hiller-Sturmhofel, S. (1999) The community- reinforcement approach. Alcohol Research & Health 23:116-127. Monti, P.M. & Rohsenow, D.J. (1999) Coping-skills training and cue-exposure therapy in the treatment of alcoholism. Alcohol Research & Health 23: 107- 115. National Institute on Alcohol Abuse and Alcoholism (2000) New Advances in Alcoholism Treatment. Alcohol Alert 49:1-4. O Farrell, T.J., & Fals-Stewart, W. (2000) Behavioral couples therapy for alcoholism and drug abuse. Journal of Substance Abuse Treatment 18:51-54. Project MATCH Research Group (1998) Matching patients with alcohol disorders to treatments: Clinical implications from Project MATCH. Journal of Mental Health 7:589-602. Smith, J.E., Meyers, R.J., & Miller, W.R. (2001) The Community reinforcement approach to the treatment of substance use disorders. The American Journal on Addictions 10(Supplement): 51-59. Wilk, A.I., Jensen, N.M., & Havighurst, T.C. (1997) Meta-analysis of randomized control trials addressing brief interventions in heavy alcohol drinkers. Journal of General Internal Medicine 12:274-283.

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