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Los Angeles - May 11, 2006 - Hythiam, Inc.
DALLAS - (BUSINESS WIRE) - June 21, 2006--Research Across America
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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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