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Cedars-Sinai Medical Center to Conduct Randomized, Controlled Study Comparing Hythiam's HANDS Protocols to Standard Medical Treatment for the Treatment of Alcohol Dependence.


LOS ANGELES -- Hythiam, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:HYTM), a healthcare services management company that delivers to treatment providers proprietary administrative services and physiological protocols designed to treat substance dependence, announced today that addiction expert Jeffery Wilkins, MD, Vice Chairman, Department of Psychiatry and Mental Health at Cedars-Sinai Medical Center Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History
Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as
, will conduct a controlled study of Hythiam's HANDS Protocols(TM) in the treatment of alcohol dependence. Dr. Wilkins is also Medical Director of Addiction Medicine and Director of Addiction Studies within the department's Clinical Trials Unit.

"With all of the recent attention on drug addiction, particularly methamphetamine dependence, it is important to remember that alcoholism is still the most serious substance abuse problem in the U.S.," said Terren S. Peizer, Hythiam's Chairman and CEO. "Hythiam is honored to be working with the prestigious Clinical Trials Unit of Cedars-Sinai's Department of Psychiatry, which has chosen to study HANDS(TM) in a controlled setting. This study follows the recent announcement of a study of HANDS(TM) for the treatment of methamphetamine dependence."

The 80-patient randomized controlled clinical trial controlled clinical trial,
n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo.
 will test the efficacy of HANDS Protocols(TM) for alcohol dependence, as compared to standard medical treatment provided by primary care physicians. Treatment seeking patients who meet criteria for alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders Diagnostic and Statistical Manual of Mental Disorders /Di·ag·nos·tic and Sta·tis·ti·cal Man·u·al of Men·tal Dis·or·ders/ (DSM) a categorical system of classification of mental disorders, published by the American Psychiatric Association, that delineates objective  - Fourth Edition (DSM-IV DSM-IV
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). This reference book, published by the American Psychiatric Association, is the diagnostic standard for most mental health professionals in the United States.
), will be candidates eligible for the study.

The study will begin with both groups of patients being admitted for two days of in-patient care. Unlike conventional studies for alcoholism pharmacotherapies, patients will not be required to be alcohol abstinent prior to enrollment. In the comparative arm however, some patients may be required to undergo detoxification (using benzodiazepines Benzodiazepines Definition

Benzodiazepines are medicines that help relieve nervousness, tension, and other symptoms by slowing the central nervous system.
Purpose

Benzodiazepines are a type of antianxiety drugs.
) during their hospitalization. Those treated with HANDS(TM) will not have benzodiazepines administered to them and will immediately receive the protocol medications.

During the first month of aftercare, patients assigned to the HANDS treatment will continue medications guided by the HANDS protocol; patients assigned to treatment as usual may receive medications usually prescribed for relapse prevention, such as acamprosate, naltrexone, Antabuse and anti-depressants. Outcome measures over the next four months will include:

--Self-report and biological measures of alcohol use

--Cravings for alcohol

--Health measures

--Cognitive function assessed by neuropsychiatric tests

--Quality of life measures

--Participation in recovery activities and,

--Psychosocial treatments

"The treatment of alcohol abuse is one that requires new therapeutic options," said Jeffery N. Wilkins, MD, Vice Chairman, Department of Psychiatry and Mental Health at Cedars-Sinai. "Primary care physicians currently have limited options when treating patients seeking treatment for alcohol dependence. Existing behavioral treatments and programs are either not effective or not accessible for many patients, especially those who do not have the funds or the time to commit to residential treatment or intensive outpatient counseling. This study is being driven by the fact that there is a significant need for acute medical interventions that can initiate and maintain abstinence."

In addition to Dr. Wilkins' position at Cedars Sinai, he is an Adjunct Professor of Psychiatry and Behavioral Sciences at the David Geffen School of Medicine at the University of California, Los Angeles UCLA comprises the College of Letters and Science (the primary undergraduate college), seven professional schools, and five professional Health Science schools. Since 2001, UCLA has enrolled over 33,000 total students, and that number is steadily rising.  (UCLA). Dr. Wilkins' clinical investigations have received funding from the National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is a United States federal-government research institute whose mission is to "lead the Nation in bringing the power of science to bear on drug abuse and addiction. , the National Institute of Mental Health The National Institute of Mental Health (NIMH) is part of the federal government of the United States and the largest research organization in the world specializing in mental illness.  and the Veterans Administration. He has conducted studies and reviews on existing pharmacotherapies including Naltrexone for the treatment of alcohol dependence.

A board-certified psychiatrist, Dr. Wilkins is a diplomate dip·lo·mate
n.
One who has received a diploma, especially a physician certified as a specialist by a board of examiners.


diplomate
(dip´l
 of the American Board of Medical Examiners and the American Board of Psychiatry and Neurology The American Board of Psychiatry and Neurology, Inc. (ABPN) sets the standards for training and certifying psychiatrists and neurologists in the United States, with the self-stated aim of promoting excellence in practice through its certification process. , from which he has received and added qualification in addiction psychiatry. He has written articles for numerous peer-reviewed publications, including the American Journal of Psychiatry The American Journal of Psychiatry (AJP) is the most widely read psychiatric journal in the world. It covers topics on biological psychiatry, treatment innovations, forensic, ethical, economic, and social issues. , Archives of General Psychiatry Archives of General Psychiatry is a monthly professional medical journal published by the American Medical Association. Archives of General Psychiatry publishes original, peer-reviewed articles about psychiatry, mental health, behavioral science and related fields. , Biological Psychiatry and the Journal of Drug and Alcohol Dependence Drug and Alcohol Dependence is an international scientific journal on biomedical and psychosocial approaches. Its mission is to publish original research, scholarly reviews, commentaries, and policy analyses in the area of drug, alcohol and tobacco use and dependence. . Dr. Wilkins received his bachelor's degree from the University of Notre Dame and his medical degree from the University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report.[3] It is a Public Ivy. [1] For graduate studies, most of UCSD's Ph.D.  (UCSD) School of Medicine.

About Cedars-Sinai Medical Center

One of only five hospitals in California List of hospitals in California (U.S. state), grouped by county and sorted by hospital name. Alameda County
  • Alameda Hospital - Alameda, California
  • Alta Bates Medical Center - Berkeley, California
  • Washington Hospital - Fremont, California
 whose nurses have been honored with the prestigious Magnet destination, Cedars-Sinai Medical Center is one of the largest non-profit academic medical centers in the Western United States Noun 1. western United States - the region of the United States lying to the west of the Mississippi River
West

Santa Fe Trail - a trail that extends from Missouri to New Mexico; an important route for settlers moving west in the 19th century
. For 17 consecutive years, it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area residents, Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and was recently fully accredited by the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP). Additional information is available at www.cedars-sinai.edu.

About HANDS(TM)

Hythiam's HANDS Protocols(TM) are designed for use by healthcare providers to treat those diagnosed with dependencies to alcohol, cocaine, methamphetamine and other addictive stimulants, as well as combinations of these drugs. The HANDS Protocols(TM) include medically supervised procedures designed to target receptor sites in the brain that regulate neurotransmitters implicated in brain processes of substance dependency. Changes in the brain's neurochemistry neurochemistry /neu·ro·chem·is·try/ (-kem´is-tre) the branch of neurology dealing with the chemistry of the nervous system.

neu·ro·chem·is·try
n.
 underlie the hallmarks of substance dependency, including craving, tolerance, withdrawal symptoms and relapse. The HANDS Protocols(TM) also provide for a maintenance program that includes medications and incentives for patients to continue with the recovery process through individualized continuing care programs. As a result, the HANDS Protocols(TM) represent a comprehensive approach to managing substance dependence that is designed to address both the physiological and psychological aspects of the disease, thereby offering patients an opportunity to transition into a healthier lifestyle.

About Hythiam, Inc.

Hythiam is a healthcare services management company, focused on delivering solutions for those suffering from alcoholism and other substance dependencies. Hythiam researches, develops, licenses and commercializes innovative physiological treatment protocols for substance dependence. Additionally, Hythiam provides proprietary administrative services to assist physicians and facilities with staff education, marketing and sales support, and outcomes tracking for data analysis. For further information please visit www.hythiam.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history and lack of statistically significant formal research studies, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and substantial regulation in the healthcare industry; and additional risks factors as discussed in the reports filed by the company with the Securities and Exchange Commission, which are available on its website at http://www.sec.gov.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jun 27, 2005
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