NALTREXONE OR SPECIALIZED ALCOHOL COUNSELING AN EFFECTIVE TREATMENT FOR ALCOHOL DEPENDENCE WHEN DELIVERED WITH MEDICAL MANAGEMENT

[Guest guest]

U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH NIH News National Institute on Alcohol Abuse and Alcoholism (NIAAA) http://www.niaaa.nih.gov/ EMBARGOED FOR RELEASE: Tuesday, May 2, 2006; 4:00 p.m. ETCONTACT: NIAAA Press Office, 301-443-0595, 301-443-3860,abradley@... NALTREXONE OR SPECIALIZED ALCOHOL COUNSELING AN EFFECTIVE TREATMENT FOR ALCOHOL DEPENDENCE WHEN DELIVERED WITH MEDICAL MANAGEMENTThe medication naltrexone and up to 20 sessions of alcohol counseling bya behavioral specialist are equally effective treatments for alcoholdependence when delivered with structured medical management, accordingto results from "Combining Medications and Behavioral Interventions forAlcoholism" (The COMBINE Study). Results from the National Institutes ofHealth-supported study show that patients who received naltrexone,specialized alcohol counseling, or both demonstrated the best drinkingoutcomes after 16 weeks of outpatient treatment. All patients alsoreceived Medical Management (MM), an intervention consisting of ninebrief, structured outpatient sessions provided by a health careprofessional. Contrary to expectations, the researchers found no effecton drinking of the medication acamprosate and no additive benefit fromadding acamprosate to naltrexone. Effect of Combined Pharmacotherapiesand Behavioral Interventions for Alcohol Dependence appears in thecurrent issue of the "Journal of the American Medical Association",Volume 295, Number 17, pages 2003-2017.NIH's National Institute on Alcohol Abuse and Alcoholism (NIAAA)launched COMBINE in 2001 to identify the most effective currenttreatments and treatment combinations for alcohol dependence. Thelargest clinical trial ever conducted of pharmacologic and behavioraltreatments for alcohol dependence, COMBINE was carried out at 11academic sites that recruited and randomly assigned 1383 recentlyabstinent, alcohol-dependent patients to one of nine treatment groups(To view an image of the COMBINE Study Design, please seehttp://www.niaaa.nih.gov/NR/rdonlyres/BEF83BDB-0D1F-41D2-9C71-CE38BB31961D/0/ChartCOMBINE1.JPG. Note: For some users, this link will be inactivedue to email formatting properties. To view another version of the link,please see http://www.nih.gov/news/pr/may2006/niaaa-02.htm).Eight treatment groups received MM; four of these received naltrexone(100 milligrams a day), acamprosate (3 grams a day), both naltrexone andacamprosate, or placebo pills. The other four groups received inaddition specialized alcohol counseling. Termed Combined BehavioralIntervention (CBI), the counseling integrated cognitive-behavioraltherapy, motivational enhancement, and techniques to enhance mutual helpgroup participation -- all treatments shown in earlier studies to bebeneficial. Patients assigned to the specialized alcohol counselingcould receive up to twenty 50-minute sessions in addition to medicalmanagement; the median number received was 10 sessions. To test for anyeffects of pill taking (placebo), the researchers assigned some patientsto a ninth group that received specialized alcohol counseling, but nopills, and no more than four visits with a health professional forgeneral medical advice.During the 16 weeks of treatment and 1 year after the treatment, theresearchers assessed the patients for the percentage of days abstinentfrom alcohol and time to the first heavy drinking day, defined as 4 ormore drinks per day for women and 5 or more drinks per day for men. Theyalso assessed the odds of good clinical outcome, defined as abstinenceor moderate drinking without alcohol-related problems. As in other largeclinical trials, the researchers found that most patients showedsubstantial improvement during treatment and that both the overall levelof improvement and the differences between treatment groups diminishedduring the follow-up period. In the COMBINE study, however, naltrexonecontinued to show a small advantage for preventing relapse at 1 yearafter the end of active treatment. Specific findings from the COMBINEstudy are summarized at (To view a Microsoft Word document of COMBINEFindings: Highlights, please seehttp://www.niaaa.nih.gov/NR/rdonlyres/E26CD34E-95C4-4712-B78E-741E16150537/0/COMBINEFINDINGS.doc. Note: For some users, this link will beinactive due to email formatting properties. To view another version ofthe link, please see http://www.nih.gov/news/pr/may2006/niaaa-02.htm)."These results demonstrate that either naltrexone or specialized alcoholcounseling -- with structured medical management -- is an effectiveoption for treating alcohol dependence," said Mark L. Willenbring, M.D.,Director, Division of Treatment and Recovery Research, NIAAA. "AlthoughMM is somewhat more intensive than the alcohol dependence interventionsoffered in most of today's health care settings, it is not unlike otherpatient care models such as initiating insulin therapy in patients withdiabetes mellitus. MM's application in primary care and general mentalhealth care settings would expand access to effective treatmentdramatically, while offering patients greater choice." To expand itsapplication, NIAAA will develop an abbreviated version of MM to beavailable in early summer. Print copies of the treatment manuals used inCOMBINE are available by order fromhttp://www.niaaa.nih.gov/Publications/EducationTrainingMaterials."The COMBINE results provide guidance for applying today's treatmenttools. NIAAA continues to explore new treatment tools in more than 50current medication trials, in studies to better understand themechanisms of action in behavioral treatments, and in our search for newmolecular targets and novel compounds for clinical testing," accordingto Raye Z. Litten, Ph.D., COMBINE's government director and co-leader ofNIAAA medications development team.COMBINE chairpersons F. Anton, M.D., Department of Psychiatry,Medical University of South Carolina, and O'Malley, Ph.D.,Yale University School of Medicine, and Drs. Willenbring and Littendiscussed the COMBINE results in a news teleconference on May 1, 2006,from 1:00 to 2:00 PM.For interviews with Drs. Anton and O'Malley, telephone 301/443-3860through May 2. Otherwise, you may reach Drs. Anton and O'Malley and theother COMBINE Study Authors) at their respective institutions. (To viewa Microsoft Word document of the authors, please seehttp://www.niaaa.nih.gov/NR/rdonlyres/80177F7E-D751-4FE2-B0D9-B7438D723697/0/COMBINEStudyAuthorsChart.doc. Note: For some users, this link willbe inactive due to email formatting properties. To view another versionof the link, please seehttp://www.nih.gov/news/pr/may2006/niaaa-02.htm). For interviews withDrs. Willenbring and Litten, please telephone the NIAAA Press Office,301/443-3860.The National Institute on Alcohol Abuse and Alcoholism, part of theNational Institutes of Health, is the primary U.S. agency for conductingand supporting research on the causes, consequences, prevention, andtreatment of alcohol abuse, alcoholism, and alcohol problems anddisseminates research findings to general, professional, and academicaudiences. Additional alcohol research information and publications areavailable at www.niaaa.nih.gov. The National Institutes of Health (NIH) -- "The Nation's MedicalResearch Agency" -- includes 27 Institutes and Centers and is acomponent of the U.S. Department of Health and Human Services. It is theprimary federal agency for conducting and supporting basic, clinical andtranslational medical research, and it investigates the causes,treatments, and cures for both common and rare diseases. For moreinformation about NIH and its programs, visit www.nih.gov. ## This NIH News Release is available online at:http://www.nih.gov/news/pr/may2006/niaaa-02.htm.