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  DISCOVER BRIDGE BACK TO LIFE CENTER:  
  Bridge Back to Life to Offer Hythiam's PROMETA Treatment Protocol in
Three Initial Locations
 


 

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Los Angeles - May 11, 2006 - Hythiam, Inc.


DALLAS - (BUSINESS WIRE) - June 21, 2006--Research Across America

 

 

New York Based Treatment Center to Offer PROMETA among Six Clinics
Located in Manhattan and Clinics in Long Island and Staten Island

LOS ANGELES - May 11, 2006 - Hythiam, Inc. (NASDAQ:HYTM), which licenses the PROMETA(TM) protocols designed to target the biology of substance dependence, announced today that the PROMETA protocols have been licensed to the highly renowned Bridge Back To Life Centers in the greater New York metropolitan area.

Tom Markoski D.O., Philip Gianelli M.D. and Lyubov Gorelick M.D. will administer PROMETA at Bridge Back to Life Center clinics located in Manhattan, Long Island, and Staten Island. Bridge Back to Life has a total of six facilities in New York City. As a whole, the center treats between 1,200 - 1,500 patients per week for substance dependency disorders and over 100 counselors are staffed to also
provide cognitive group and individual therapy to patients.

"We believe PROMETA will be a remarkable adjunct to what we can offer the city in combating the serious substance abuse problem that is confronting various populations in New York, including business people; the gay community; and the younger people active in the club scene," said Gary Butchen, President of the Bridge Back to Life network. "Bridge Back to Life has made its reputation by being on the cutting edge. As treatments like PROMETA emerge, we continue to investigate the outcomes and incorporate those that show positive results into our treatment options."

"We welcome Bridge Back to Life as our partner," said Terren S. Peizer, Hythiam's Chairman and CEO. "We look forward to working with them in providing service to the substance dependent populations of Manhattan, Long Island, and Staten Island. Together we will work to provide further options for East Coast addiction treatment providers for the benefit of those who suffer from this disease."

About PROMETA

Hythiam's PROMETA treatment protocols are designed for use by healthcare providers seeking to treat individuals diagnosed with dependencies to alcohol, cocaine or methamphetamines, as well as
combinations of these drugs. The PROMETA treatment protocols comprise FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm, as well as nutritional supplements combined with psychosocial or other recovery-oriented
therapy chosen by the patient and their treatment provider. As a result, PROMETA represents an innovative approach to managing alcohol, cocaine or methamphetamine dependence that is designed to address physiological, nutritional and psychosocial aspects of the disease, and is thereby intended to offer patients an opportunity to achieve sustained recovery.

About Hythiam, Inc.

Hythiam(R) is focused on delivering solutions for those suffering from alcoholism and other substance dependencies. Hythiam researches, develops, licenses and commercializes innovative physiological
treatment protocols that seek to address 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 click on www.hythiam.com.


( BW)(TX-RESEARCH-ACROSS-AMERI)(HYTM) Study of PROMETA Protocol Shows Clinical Effectiveness; Statistically Significant Reduction in Methamphetamine Cravings and Methamphetamine Use

Business Editors/Health/Medical Writers

DALLAS--(BUSINESS WIRE)--June 21, 2006--Research Across America:

> Immediate and Persistent Positive Effect More Than Two Months
Following Treatment Completion -- Even without Benefit of
Psychosocial Treatment

> 85% Retention to Treatment; 97% of Patients Experienced
Reduction in Cravings; 80% of Participants Reported Reduction
in Methamphetamine Use

Research Across America, a nationally-recognized clinical research center, today announced results of its study of the PROMETA(TM) treatment protocol for methamphetamine dependence. Board Certified psychiatrist and addiction expert Harold C. Urschel, III, M.D., M.M.A. and lead investigator on the first clinical study of the PROMETA treatment protocol for stimulant dependence, presented the full study results today at the College on Problems of Drug Dependence's (CPDD)
annual meeting in Scottsdale, Ariz.

According to Dr. Urschel's presentation, after treatment more than 80% of study participants experienced a significant clinical benefit with no adverse events. Clinical benefit was measured through decrease in cravings, reduction of methamphetamine use, and treatment
retention. The study, which contained no psychosocial counseling support, concluded that PROMETA has demonstrated clinical utility with chronic, relapsing methamphetamine-dependent patients to help them attain and maintain abstinence, is effective in decreasing cravings and can be safely administered in an outpatient setting. Males and females appear to benefit equally from the treatment protocol.

"As investigators looking at potential treatments for stimulant dependence, we traditionally seek some signal of effect in at least one of the primary endpoints of a study. What we have discovered in
this study is positive trending in all of the primary endpoints. The PROMETA treated patients improved almost immediately with many positive benefits from the treatment, including abstinence, reduced cravings and significant improvement in their memory and concentration sustaining beyond the treatment period," said Dr. Urschel. "We observed these improvements early in the treatment period, in most cases within the first three days of starting the treatment. These results are in sharp contrast to most studies on substance dependence therapies, as other pharmacologic agents tested to date usually only show a gradual improvement over time, even when they are combined with
behavioral support and environmental modifications."

Urschel continued, "Because we were testing the PROMETA Treatment Protocols in an outpatient setting, I was very worried that due to the lack of psychosocial support, the subjects would drop out early in the study. However with the PROMETA treatment protocols, we had a high percentage of subjects complete both the treatment phase and the follow-up phase of this study, even though the subjects received no psychosocial treatment or additional treatment incentive to return weekly for two months post treatment completion. Especially noteworthy is the high rate of patient adherence to completing treatment in a patient population that is known by addiction treatment providers to
inconsistently comply with medication regimens -- most stimulant addicts drop out of treatment and stop their medications after only 1-2 days. For all of these reasons, I feel confident that we have
found the first clinically effective treatment for methamphetamine dependence.

"Clinical observations during our study also suggested that the PROMETA treatment resulted in immediate improvement in our subject's cognitive functioning, including memory, alertness and concentration. Additionally we saw improved sleep patterns and a decrease in anxiety," continued Dr. Urschel. "This observed effect of PROMETA in restoring subjects' cognitive functioning suggests its potential benefit to assist patients in their intensive outpatient treatment programs in learning the new coping skills they will need to maintain long-term abstinence from psychostimulants. Methamphetamine-dependent patients often do not benefit from sychosocial and educational treatment programs during early abstinence because they have difficulty with memory and concentration and are preoccupied with methamphetamine cravings. What is also remarkable in this case is that cravings for methamphetamine were significantly decreased, methamphetamine usage dropped dramatically, and adherence to the treatment was much higher than expected for this patient population."

Study Design

Subject screening consisted of informed consent; psychiatric evaluation; medical history and evaluation; laboratory screening; methamphetamine and other drug use history; administration of the Stimulant Craving Scale (SCS), a 10-item questionnaire that measures the subjective perception of frequency and intensity of cravings for methamphetamine; and recording of methamphetamine use during the previous 90 days using timeline follow back. Changes in self-reported cravings for methamphetamine were assessed from the screening visit to the end of the 12-week study.

Medication treatment lasted 4 weeks followed by 8 weeks of follow-up in which subjects returned for weekly office visits to provide self-report of drug use and to provide a urine specimen collected under observation.

Endpoints and Results

Patient improvement was measured by adherence to the treatment protocol, changes in self-reported cravings for methamphetamine and reduction of methamphetamine use as measured by self-report and correlated with urine testing.

1. Retention (Adherence) to treatment: 45 of 50 subjects, or 90% completed both treatment cycles, returning for 5 infusions over 23 days. There was an overall compliance rate of 85% with the treatment regimen. Thirty-six subjects (72%) attended the final follow-up visit at week 12.

2. Changes in cravings: Complete craving data were available on 31 subjects at visit 17 (day 84). Of these, 30 subjects, 97% reported a decrease in cravings (frequency of urge to use methamphetamine during the past week). Only one subject reported no change and no subject reported an increase in cravings. Among the 30 subjects whose frequency of methamphetamine cravings decreased, the mean reduction in cravings from the screening visit to study completion was 66%. This reduction is significant at p lower than .0001. There was no evidence of a gender effect on craving reduction.

3. Reduction of methamphetamine use: 40 of the 50 (80%) participants reported reduction in methamphetamine use during the course of the study. Of the completers (n=36), an average
reduction in methamphetamine use of 65% was found with 72% of days abstinent. Among those participants who completed the study, the average frequency of methamphetamine abstinent days
increased from 20% of days (during the 90 days prior to treatment) to 72% of the 84 days following the first infusion.

Among study completers, the average frequency of days used dropped from 80% of days (during the 90 days prior to treatment), to 28% of the 84 days following the first treatment. This reduction in self-reported use days is 65% (p lower than .0001). Negative urine drug screen results matched
self-reported denials of methamphetamine use in 84.7% of samples. There was no evidence of a gender effect.

4. No serious adverse events occurred during any portion of the PROMETA treatment. Mild and transient side effects of the treatment protocol included fatigue, dizziness, dry mouth, unusual taste and discomfort at the IV infusion site. No subject discontinued the protocol because of side effects.

Excerpted from Poster

Discussion

In summary, investigators observed a highly significant reduction in methamphetamine use which persisted over the 2-month, non-medication follow-up period. There was an immediate and persisting
positive treatment effect for PROMETA for more than 2 months following treatment completion in the intent-to-treat samples. Taking into account decreased cravings, reduction in methamphetamine use, and treatment retention, 80% of subjects experienced a significant clinical benefit as the result of the PROMETA treatment.

The limitations of an open-label study notwithstanding, the magnitude and persistence of this effect are remarkable in several respects, as clinical benefit was seen in daily using, chronically relapsing methamphetamine addicts. The results are all the more remarkable when one takes into account the fact that most psychostimulant addicts drop out of outpatient treatment after only a few days.

Seventy-two percent (72%) of the subjects returned for the final follow-up visit, 8 weeks after completing medication treatment.

Second, the findings were observed in the context of what was essentially a pharmacologic intervention only. Since the study did not include psychotherapy or a specific substance abuse counseling component (e.g., cognitive behavioral therapy), the investigators contend that the data reflect a primary pharmacologic effect. If the psychosocial component of the PROMETA treatment protocol had been implemented in this study the results in all likelihood would be even more robust.

Third, PROMETA was clinically effective in reducing the severity of methamphetamine cravings and frequency of methamphetamine use during the medication treatment phase and during the 2 months following treatment. In view of the lasting positive impact of the PROMETA treatment over this time span, it is not likely that this benefit can be attributed to a placebo effect.

The PROMETA treatment protocols, provided to RAA by Hythiam, Inc. (Nasdaq:HYTM), are designed for use by healthcare providers seeking to treat individuals diagnosed with dependencies to alcohol, cocaine or methamphetamine, as well as combinations of these drugs. The medical component of the PROMETA treatment protocol for methamphetamine dependence evaluated in this study is designed to address neurological changes caused or worsened by addiction. It comprises nutritional
supplementation, as well as FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm.

Information about Hythiam is available www.hythiam.com.

Dr. Harold C. Urschel III is an accomplished researcher, clinician and a recognized leader in addiction medicine. He is a Clinical Instructor of Psychiatry at The University of Texas Southwestern Medical Center at Dallas' Department of Psychiatry and has published numerous articles on addiction treatment in journals and textbooks including Psychopharmacology Bulletin, Archives of General Psychiatry and the DSM-IV Sourcebook. He is also a national lecturer on current pharmacological agents to enhance addiction treatment for all major classes of alcohol and drug dependence, Chief of Medical Strategy for EnterHealth LLC, an internet site delivering addiction and mental health treatment online www.enterhealth.com and an advisory Board Member for the Betty Ford Center Children's Program. Dr. Urschel has a Masters in Management (Sloan Fellow) from Stanford University Graduate School of Business.

About Research Across America

Research Across America is an Investigator Site Network (Non-SMO) with multi-specialty sites located in Dallas, TX, El Paso, TX, New York, NY, Reading, PA, and their surrounding areas. The physicians
affiliated with Research Across America have conducted over 1,000 clinical trials since 1989. Since that time, Research Across America has worked with most major pharmaceutical companies and contract research organizations (CROs) in a wide variety of therapeutics including cardiology, endocrinology, gastroenterology, neurology, and urology. Dr Urschel is a founding partner of the CNS Research division within RAA, which investigates new treatments in the Addiction and General Psychiatric areas. For further information, please visit www.ResearchAcrossAmerica.com.

 

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