PA-02-067: TREATMENT OF ALCOHOL ABUSE/DEPENDENT PATIENTS WITH PSYCHIATRIC COMORBIDITY

Department of Health
and Human Services (HHS)

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TREATMENT OF ALCOHOL ABUSE/DEPENDENT PATIENTS WITH PSYCHIATRIC COMORBIDITY RELEASE DATE: February 25, 2002 PA NUMBER: PA-02-067 EXPIRATION DATE: February 20, 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 The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking research grant applications on the treatment of alcohol dependent/abuse patients with comorbid psychiatric disorder(s) (includes Axis I and Axis II disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]). The purpose of this program announcement is to not only develop effective interventions, but to also develop behavioral techniques to enhance the engagement, retention, and adherence of patients with comorbidities to treatment programs. Research on the specific assessment and treatment needs of this population is in early stages, and thus well-designed research projects are needed. In particular, effective pharmacological and behavioral interventions tailored to the comorbid conditions need to be discovered, developed, and evaluated. It is also important to understand the effects of treating the concurrent disorders on alcoholism treatment outcomes. The intervention strategy to address both the alcohol dependence and the psychiatric condition might depend on the type of comorbidity and the subtype of comorbid alcoholic patient. All applications submitted in response to this program announcement should be conducted in humans. RESEARCH OBJECTIVES Background Alcohol dependent individuals have exceptionally high rates of co- occurring psychiatric disorders (Regier et al., 1990, Grant and Harford, 1995, Kessler et al., 1996). For example, in the U.S. alcohol abuse and dependent patients are 20.1 times more likely to have a diagnosis of antisocial personality disorder than are nonalcoholics (Regier et al., 1990). Comparable odds ratios are 1.7 to 3.6 times for major depression, 2.4 times for panic disorder, 1.4 times for phobia, 5.1 times for bipolar disorder, 3.3 times for schizophrenia, and 7.1 times for other drug addiction (Helzer and Pryzbeck, 1988, Regier et al. 1990, Grant and Harford, 1995). Moreover, a significant number of alcoholics, especially women, exhibit two or more comorbidities. Interestingly, this population is more likely to seek alcoholism treatment than non-comorbid alcoholics. In spite of comorbidity rates being especially high among alcoholics in treatment, the prognosis for treatment is often poor, particularly among patients with more severe psychiatric illness. Furthermore, alcoholics with collateral psychopathology appear less compliant with treatment and are more likely to drop out of treatment, have a higher suicide rate, and receive less support for sobriety from family and the work environment (Cornelius et al., 1995, Woody, 1996, Drake and Mueser, 1996, Greenfield et al., 1998). Development of effective strategies to treat this population is at early stages of research. The type of strategy may depend on the type of psychiatric disorder and the severity of the psychiatric condition. For example, McLellan et al. (1983) demonstrated that alcoholics with low psychiatric severity improved with all tested treatment programs, those with medium psychiatric severity demonstrated a variation of outcomes to different treatment interventions, while those with high psychiatric severity showed no improvement in any treatment. Progress has recently been made in conducting state-of-the-art studies of pharmacological and behavioral interventions in a number of comorbid psychiatric disorders. For example, several NIAAA-supported trials have been completed in depressed alcoholics. Results have been mixed. Mason et al. (1996) demonstrated that while the tricyclic antidepressant desipramine reduced symptoms of depression in alcoholic patients with major depression, it had limited success in reducing drinking. Similarly, McGrath et al. (1996) found that the tricyclic antidepressant imipramine was effective in reducing depressive symptoms in alcoholics with mild to moderate depression, but no differences in alcohol intake between the imipramine and placebo groups were evident. Effects of selective serotonin reuptake inhibitors (SSRIs) are less clear. Cornelius and colleagues (1997) showed that fluoxetine diminished both depression and drinking in severely depressed alcoholics. In contrast, Pettinati et al. (2001), McGrath (1998), and Moak et al. (2001) reported that the SRRI sertraline or fluoxetine was no more effective than placebo in reducing the severity of depression or drinking in a population of less severely depressed alcoholics. Thus it appears that although antidepressants, in at least certain conditions, can improve depression, and to at least a limited extent, reduce drinking, their effects may vary and may also be a function of subtype of depressed alcoholics. Investigations are currently underway to determine if the pharmacological treatment of both disorders (naltrexone for alcoholism and sertraline or fluoxetine for depression) is more effective than monotherapy. Few studies have been conducted to test the efficacy of behavioral therapies in depressed alcoholics (Brown and Ramsey, 2000). Brown et al. (1997) found that cognitive-behavioral therapy for depression was effective not only in improving depression but also in decreasing frequency of drinking in alcoholics with elevated depressive symptoms. However, future studies on depressed alcoholics need to develop and test behavioral therapies that address both depression and alcohol disorders and also to determine their optimal integration with pharmacological agents. Research has just begun to identify and evaluate effective treatments for alcohol abuse/dependent patients with generalized anxiety disorder, social anxiety disorder, posttraumatic stress disorder (PTSD), and panic disorder. Buspirone, a partial 5-HT1A agonist, has been evaluated in several trials using alcoholic patients with a collateral generalized anxiety disorder. Tollefson et al. (1992) and Kranzler et al. (1994) found it effective in reducing the symptoms of anxiety in anxious alcoholics. Moreover, Kranzler and colleagues showed that concurrent with improvement of anxiety, patients treated with buspirone were more likely to stay in treatment and to delay return to heavy drinking. On the other hand, Malcolm et al. (1992) failed to demonstrate differences in improvement of anxiety or reduction in drinking outcome in buspirone-treated versus placebo-treated anxious alcoholics. In alcoholic patients suffering from a comorbid social anxiety disorder, Randall et al. (2001) found unexpectedly that a cognitive behavior therapy specific for alcohol dependence was more effective in reducing drinking than one designed to simultaneously address both alcoholism and social anxiety. Further, the improvement in social anxiety was equivalent for both therapies. A new trial has been initiated to determine efficacy of paroxetine in individuals with a dual-diagnosis of alcohol use disorder and social anxiety disorder. Najavits et al. (1998) reported that a group cognitive behavioral therapy designed for women suffering from both substance dependence and PTSD was effective in reducing substance use and improving trauma- related symptoms and family functioning in this population (59 percent were dependent on alcohol). Trials are currently underway to evaluate naltrexone in comorbid PTSD alcoholics and a cognitive behavioral therapy for panic disorder in patients dually diagnosed with alcohol dependence and panic disorder. Finally, even less is known about the treatment of alcoholics with a more severe mental illness. NIAAA is currently supporting a trial of valproate in alcohol dependent patients with bipolar disorder and clozapine in schizophrenic alcoholics. In a recent pilot study, clozapine was found to be effective in reducing the frequency of drinking in patients dually diagnosed with alcohol use disorder and schizophrenia or schizoaffective disorder (Drake et al., 2000). In summary, research to evaluate effective pharmacological and behavioral treatments for patients diagnosed with alcohol use disorder and psychiatric comorbidity is still in early stages. The purpose of this program announcement is to stimulate additional quality research to develop effective treatments to improve outcome and also to increase engagement, retention, and adherence to a treatment program across a wide population of alcohol abuse/dependent subjects with psychiatric disorder(s). Specific Areas of Interest A wide variety of research opportunities exist for advancing the treatment of this understudied population. Research on topics such as the following is urged. o Development and evaluation of specialized pharmacological and behavioral interventions for comorbid patients. This would include development of effective treatment strategies for alcoholic patients with multiple comorbidities (e.g., depression, anxiety disorders, and illicit drug addiction). Appropriate combination and sequencing of pharmacological and behavioral therapies need to be explored. o Identification of patient characteristics associated with concurrent disorders. These include diagnostic status, biological status, phenotype, and developmental stage. Treatment strategies particularly suited to varying types of comorbid alcoholics need to be developed and tested. o Determination of the effects of concurrent disorders on alcoholism treatment outcomes. Does the treatment of either alcoholism or the concurrent psychiatric disorder improve outcome for the other disorder? o Design of effective treatments for comorbidity in special populations including minorities, the elderly, adolescents, women, especially those who are pregnant, individuals with fetal alcohol syndrome, those in the criminal justice system, and individuals who are HIV positive or at high risk of becoming HIV positive. It may be helpful to identify social and cultural factors that mediate and moderate motivation for treatment, adherence to treatment, and treatment outcomes. o Determination of the biological and behavioral overlaps of alcoholism and the comorbid condition. For example, do these conditions share similar neuronal circuit pathways? Do they interact in a way that causes an increase in severity of one or both conditions? This information may be helpful in the development of more effective treatment interventions. o Development of techniques for the engagement, retention, and adherence of comorbid patients in treatment. Promising behavioral techniques include motivational interviewing and contingency management. However, such techniques might have to be tailored to the type of comorbidity. o Development and evaluation of assessment and outcome instruments that measure the dimensions and characteristics of the psychopathology condition. o Identification of possible interactions of medications to treat alcoholism and concurrent psychiatric conditions as well as interactions with alcohol. Pharmacokinetic studies might also be appropriate. For example, Ciraulo et al. (1982) demonstrated that at a given dose of imipramine, patients who were both alcoholic and depressed attained lower blood levels of the medication than nonalcoholic depressed subjects. 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Charlene E. LeFauve, 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) 402-9401 Fax: (301) 443-8774 Email: clefauve@NIAAA.nih.gov 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) 443-2434 Email: jsimons@niaaa.nih.gov 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: GrantsInfo@nih.gov. 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. 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 a 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 Brown, R.A., and Ramsey, S.E. (2000). Addressing comorbid depressive symptomatology in alcohol treatment. Professional Psychology: Research and Practice 31:418-422. Brown, R.A., Evan, D.M., Miller, I.W., Burgess, E.S., and Mueller, T.I. (1997). Cognitive behavioral treatment for depression in alcoholism. Journal of Consulting and Clinical Psychology 65:715-726. Ciraulo, D.A., Alderson, L.M., Chapron, D.J., Jaffe, J.H., Subbarao, B., and Kramer, P.A. (1982). Imipramine disposition of alcoholics. Journal of Clinical Psychopharmacology 2:2-7. Cornelius, J.R., Salloum, I.M., Ehler, J.G., Jarrett, P.J., Cornelius, M.D., Perel, J.M., Thase, M.E., and Black, A. (1997). Fluoxetine in depressed alcoholics. Archives of General Psychiatry 54:700-705. Cornelius, J.R., Salloum, I.M., Mezzich, J., Cornelius, M.D., Jr., Fabrega, H., Ehler, J.G., Ulrich, R.F., Thase, M.E., and Mann, J.J. (1995). Disproportionate suicidality in patients with comorbid major depression and alcoholism. The American Journal of Psychiatry 152:358-364. Drake, R.E., Xie, H., McHugo, G.J., and Green, A.I. (2000). The effects of clozapine on alcohol and drug use disorders among patients with schizophrenia. Schizophrenia Bulletin 26: 441-449. Drake, R.E., and Mueser, K.T. (1996). Alcohol-use disorder and severe mental illness. Alcohol Health and Research World 20:87-93. Grant, B.F. and Harford, T.C. (1995). Comorbidity between DSM-IV alcohol use disorders and major depression: Results of a national survey. Drug and Alcohol Dependence 39: 197-206. Greenfield, S.F., Weiss, R.D., Muenz, L.R., Vagge, L.M., Kelly, J.F. Bello, L.R., and Michael, J. (1998). The effect of depression on return to drinking: A prospective study. Archives of General Psychiatry 55:259-265. Helzer, J.E., and Pryzbeck, T.R. (1988). The co-occurrence of alcoholism with other psychiatric disorders in the general population and its impact on treatment. Journal of Studies on Alcohol 49:219-224. Kessler, R.C., Nelson, C.B., McGonagle, K.A., Edlund, M.J., Frank, R.G., and Leaf, P.J. (1996). The epidemiology of co-occurring addictive and mental disorders: Implications for prevention and service utilization. American Journal of Orthopsychiatry 66:17-31. Kranzler, H.R., Burleson, J.A., Del Boca, F.K., Babor, T.F., Korner, P., Brown, J., and Bohn, M.J. (1994). Buspirone treatment of anxious alcoholics: A placebo-controlled trial. Archives of General Psychiatry 51:720-731. Malcom, R., Anton, R.F., Randall, C.L., Johnston, A., Brady, K., and Thevos, A. (1992). A placebo-controlled trial of buspirone in anxious inpatient alcoholics. Alcoholism: Clinical and Experimental Research 16:1007-1013. Mason, B.J., Kocsis, J.H., Ritvo, E.C., and Cutler, R.B. (1996). A double-blind placebo-controlled trial of desipramine in primary alcoholics stratified on the presence or absences of major depression. Journal of American Medical Association 275:1-7. McGrath, P.J. (1998). Fluoxetine for the treatment of alcoholism and depression. In R. Litten (Chair), Does 5-HT pharmacotherapy have a role in alcohol treatment? Symposium conducted at the Annual Meeting of the Research Society on Alcoholism, Hilton Head, SC. McGrath, P.J., Nunes, E.V., Stewart, J.W., Goldman, D., Agosti, V., Ocepek-Welikson, K., and Quitkin, F.M. (1996). Imipramine treatment of alcoholics with primary depression: A placebo-controlled clinical trial. Archives of General Psychiatry 53:232-240. McLellan, A.T., Luborsky, L., Woody, G.E., O"Brien, C.P., and Druley, K.A. (1983). Predicting response to alcohol and drug abuse treatments: Role of Psychiatric Severity. Archives of General Psychiatry 40: 620-625. Moak, D.H., Voronin, K.E., Latham, P.K., and Anton, R.F. (2001). A double-blind placebo-controlled treatment study of sertraline in depressed alcoholics: Preliminary analysis. Alcoholism: Clinical and Experimental Research 25: 94A. Najavits, L.M., Weiss, R.D., Shaw, S.R., and Muenz, L.R. (1998). "Seeking safety:" Outcome of a new cognitive-behavioral psychotherapy for women with posttraumatic stress disorder and substance dependence. Journal of Traumatic Stress 11: 437-456. Pettinati, H.M., Volpicelli, J.R., Luck, G., Kranzler, H.R., Rukstalis, M.R., and Cnaan, A. (2001). Double-blind clinical trial of sertraline treatment for alcohol dependence. Journal of Clinical Psychopharmacology 21:143-153. Randall, C.L., Thomas, S., and Thevos, A.K. (2001). Concurrent alcoholism and social anxiety disorder: A first step toward developing effective treatments. Alcoholism Clinical and Experimental Research 25: 210-220. Regier, D.A., Farmer, M.E., Rae, D.S., Locke, B.Z., Keith, S.J., Judd, L.L., and Goodwin, F.K. (1990). Comorbidity of mental disorders with alcohol and other drug abuse: Results from the epidemiologic catchment area (ECA) study. Journal of the American Medical Association 264:2511-2518. Tollefson, G.D., Montague-Clouse, J., and Tollefson, S.L. (1992). Treatment of comorbid generalized anxiety in a recently detoxified alcoholic population with a selective serotonergic drug (buspirone). Journal of Clinical Psychopharmacology 12:19-26. Woody, G. (1996). The challenge of dual diagnosis. Alcohol Health and Research World 20:76-80.

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