Veteran Clinical Researcher Dr. Harold Urschel to Investigate Hythiam's HANDS Protocols for the Treatment of Methamphetamine Dependence; First of Several Anticipated Controlled Studies on Hythiam's HANDS Protocols.

LOS ANGELES -- Hythiam, Inc. (NASDAQ: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 renowned addiction expert and Board Certified Psychiatrist Harold C. Urschel, III, M.D., M.M.A., intends to conduct a study of Hythiam's HANDS Protocols(TM) in the treatment of methamphetamine dependence.

The 30-patient open label study will be conducted on treatment-seeking subjects who are currently methamphetamine dependent. Upon final approval to begin the study, each qualified subject will participate in the trial over a three month period in Dallas, at the Research Across America clinical research facility. Research Across America has conducted over 1,000 clinical trials for more than 50 pharmaceutical companies, as well as most contract research organizations and numerous biotech companies. The CNS Research Group for Research Across America is headed by Dr. Urschel and specializes in the areas of chemical dependency (addiction); general psychiatry; and general neurological disorders, including Alzheimer's disease, Parkinson's disease, chronic pain, headaches and epilepsy.

"Hythiam is proud of its leadership role in developing an acute medical intervention for methamphetamine dependency and is gratified that Dr. Urschel, a highly-regarded addiction psychiatrist with a strong background in research, is taking this opportunity to rapidly provide the industry with data on a much needed physiological option for treating this disease," said Terren S. Peizer, Hythiam's Chairman and CEO. "Hythiam seeks to build upon a solid foundation of clinical evidence for HANDS(TM) and this will be the first of several research studies that we anticipate will be initiated in ensuing months, including both comparative as well as double-blind placebo-controlled studies.

"The serious consequences of methamphetamine addiction continue to spread rapidly across all cultures, races and societies," Peizer continued. "Acknowledged by experts as highly resistant to treatment, its cascading effects cause significant and long-standing problems -- not only to the patient but to families and communities. National media coverage, as well as studies in Europe, Asia and Africa have spoken to the gravity and scope of this problem, highlighting the link between methamphetamine addiction, increased transmission of disease and escalating criminal behavior."

Dr. Urschel has worked for years designing addiction treatment protocols and treating patients with various substance dependencies, including alcohol, cocaine and methamphetamine. An accomplished researcher, over the past 15 years he has designed and conducted many studies targeted at addiction recovery, both for governmental agencies like the National Institute on Drug Abuse (NIDA) and major pharmaceutical companies. Dr. Urschel has conducted a number of notable studies, including the investigation of a new 30-day injection medication for the treatment of alcoholism and the evaluation of several new medications for the treatment of cocaine dependency. Additionally, he has published numerous articles on addiction treatments (many as lead author) in a variety of journals and textbooks, including Psychopharmacology Bulletin, Archives of General Psychiatry and the DSM-IV Sourcebook.

Dr. Urschel's study of the HANDS Protocol will include 30 men and women, 18-65 years of age, who are dependant on methamphetamine, according to the criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV). Since the aim of the study is to initiate abstinence from methamphetamine, patients will not be required to be drug or stimulant abstinent at the time of enrollment and treatment. The study will consist of an initial three-day outpatient treatment for each patient, followed by an additional two-day cycle after three weeks, and a 12-week follow up and assessment period. Primary outcomes will measure:

--Number of days abstinent from methamphetamine use following discharge from the outpatient HANDS Protocols(TM) treatment

--Change in scores for methamphetamine cravings

--Results of urine drug screens performed at weekly intervals during the 12-week evaluation period 

--In the event of patient relapse, number of days until first methamphetamine use and/or other drug use following HANDS treatment.

"Methamphetamine abuse has become a pervasive problem in our country, as has been recently reported by numerous sources; however, very few medical options exist for the treatment of methamphetamine addiction," said Dr. Urschel. "This study has been designed in order to rapidly accrue patients and provide clinical outcomes data into the market as soon as possible. I am looking forward to studying the HANDS Protocols(TM) as a potential treatment option for the countless number of people whose lives have been destroyed by this devastating illness."

Dr. Urschel explained, "The HANDS Protocol(TM) for Stimulant Dependence is a promising new treatment option for those with methamphetamine dependence. Among the neuronal pathways targeted by the components of the HANDS Protocols(TM) is the GABA system, including the GABA(A) receptor. We believe that alteration in GABA(A) function, caused or exacerbated by chronic substance abuse, may be associated with anxiety, sleep and cognition disorders. Moreover, as the major inhibitory neurotransmitter in the central nervous system, GABA plays a pivotal role in maintaining stable and rational behavior. An imbalance between the inhibitory and excitatory activity in the brain, such as occurs during substance withdrawal, can change activity in the dopamine system, as well as in other neuronal circuits, triggering undesirable symptoms and behaviors. Of the many brain reward pathways which methamphetamine affects, the Mesocortical pathway within the Limbic system is a focus of the destructive forces of methamphetamine molecules. Disruption of this pathway in addiction leads to impaired control over the important body functions of sleep, nervousness and thinking. An analogy would be that the circuit breakers within this important brain pathway have flipped off, and consequently there is significantly impaired control in the normal functioning of this pathway in methamphetamine and other addictions. The hypothesis is that restoring the balance within this pathway is analogous to resetting the circuit breakers, so that the pathway functions normally and a patient who is in recovery stays sober, and is able to have a relatively quick return to normal of their sleep and anxiety levels, as well as their thinking patterns."

Dr. Urschel continued, "Methamphetamine addiction is an extremely destructive and devastating addiction for an ever-increasing number of people in the US. To date there have been no clear-cut effective treatments, either pharmacological or behavioral which are readily available for this pervasive devastating illness. The methamphetamine molecule itself is extremely destructive to the cells in and around many important pathways within the brain. Specific imaging data have shown that normal brain function may take as long as up to a year and a half with complete sobriety after the use of methamphetamine. Consequently, within this scientific situation, an open label trial which shows positive results would be very valuable for the treatment community, as it would be a jumping off point on which to focus more detailed double-blind placebo-controlled trials. In the meantime it would offer a very potent option which could help a great number of dependent individuals and their families have success in their recovery."

In November 2004, Hythiam announced it had established a Clinical Outcomes Registry for the monitoring and evaluation of patients undergoing Hythiam's HANDS Protocols(TM) for alcohol and/or stimulant dependence at commercial licensee locations. The Clinical Outcomes Registry will be comprised of 15 sites nationwide where the HANDS Protocols(TM) are currently offered or will be offered commercially in the near future. Standard, validated outcome measure will be included for the duration of the registry period, which is expected to last approximately 24 months.

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 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 neurochemistry of the brain underlie the hallmarks of substance dependency, including craving, tolerance, withdrawal symptoms and relapse. The HANDS Protocols 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 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 Research Across America

Located across the country, Research Across America is a group of independent, professional clinical research sites that provide various medical study capabilities. Headquartered in Dallas, other sites include Carlsbad, Calif.; Reading, Pa.; and New York. Research Across America has conducted over 1,000 clinical trials for more than 50 pharmaceutical companies, as well as most contract research organizations and numerous biotech companies. Its vast network of board-certified physician investigators and professional research coordinators are experienced in all therapeutic areas. The CNS Group at Research Across America specializes in clinical trials of investigational and conventional medications for treating general psychiatric, addiction and neurological disorders. The organization is physician owned and operated, maintaining the highest medical standards for patient care and data integrity.

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 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.