Investigators Observe Significant Reduction in Methamphetamine Cravings and Use in Study of Component of Hythiam's PROMETA Treatment Program Published in Mayo Clinic Proceedings Journal
Posted on: Monday, 1 October 2007, 09:00 CDT
Hythiam, Inc. (NASDAQ:HYTM) today announced that the Mayo Clinic Proceedings medical journal published in their October installment, an open-label study by Dr. Harold C. Urschel, III, M.D., M.M.A. of the pharmacological component of the PROMETA® Treatment Program for methamphetamine dependence. The study found that this component of the PROMETA® Treatment Program persistently reduced methamphetamine cravings and use. The Mayo Clinic Proceedings journal is a peer-reviewed publication of the prestigious Mayo Clinic in Rochester, Minnesota.
According to the publication, 85% (n=42) of the study's 50 participants adhered to the 4-week treatment protocol and the majority (n=36) completed the entire 12-week study even though they were not provided additional medication, specific drug-abuse counseling, or psychotherapy during the 8-week follow-up period. Subjects experienced a statistically significant reduction in cravings for methamphetamine with no adverse events from the treatment. 97% (n=30) of those who completed the study reported a reduction in frequency of cravings, with an average reduction of 66%. Additionally, a significant reduction of methamphetamine use was also observed. A completer analysis that attributed the value of the most recent urine drug screen to missing days of data showed a 66% reduction in methamphetamine use days from 80% of the 90 days prior to the first infusion, to only 27% of the 84 days following the first infusion.
The study found that outpatient treatment with the pharmacologic component of the proprietary PROMETA® Treatment Program was feasible, well-tolerated, and significantly reduced methamphetamine cravings and use among methamphetamine-dependent patients. Males and females appear to benefit equally from the treatment protocol.
Because of the intensity and unique nature of methamphetamine cravings, patients often do not benefit from psychosocial and educational treatment programs during early abstinence because they have difficulty with memory and concentration, and remain preoccupied with thoughts of drug use. In his study, Dr. Urschel reported a significant decrease in cravings for methamphetamine, a significant drop in methamphetamine usage, and adherence to the treatment that was much higher than generally expected for this patient population.
"We congratulate Dr. Urschel on the honor of being published in the Mayo Clinic Proceedings and are pleased that the study and its findings have now been accepted by such a highly-respected and reputable publication," said Terren Peizer, Chairman and Chief Executive Officer of Hythiam. "PROMETA's acute impact on cravings, and the observation by clinicians in the study that cognitive enhancement was also occurring in some participants, suggests PROMETA's immediate benefit to the field of substance dependence treatment. Using PROMETA to address and stabilize cravings can help improve participation in outpatient psychosocial programs among methamphetamine-addicted individuals. With reduced cravings, active participation for individuals in such programs can include learning the new coping skills that are critical in maintaining the behavioral endpoint of long-term abstinence from psychostimulants. We also believe that this publication will create the platform for the top-line announcement of Dr. Urschel's upcoming double-blind placebo results on the use of PROMETA for methamphetamine dependence."
About Mayo Clinic Proceedings
A peer-reviewed journal, Mayo Clinic Proceedings publishes original articles, reviews and editorials dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by the Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at www.mayoclinicproceedings.com.
About the PROMETA® Treatment Program
Hythiam's PROMETA® Treatment Program is 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 PROMETA® Treatment Program includes nutritional supplements, FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm, as well as psychosocial or other recovery-oriented therapy chosen by the patient and his or her 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. To learn more, please visit www.prometainfo.com.
About Hythiam, Inc.
Hythiam, Inc. provides behavioral health management services to health plans, employers, criminal justice, and government agencies through a network of licensed and company managed providers. The company approaches the management of behavioral health disorders with a focus on using the latest medical and health technology towards improved outcomes and out-patient treatment. Hythiam also researches, develops, licenses and commercializes innovative and proprietary physiological, nutritional, and behavioral treatment programs. Hythiam offers disease management for substance dependence built around its proprietary PROMETA® Treatment Program for alcoholism and dependence to stimulants. The PROMETA® Treatment Program, which integrates behavioral, nutritional, and medical components, is available through both licensed treatment providers and company managed PROMETA® Centers. Hythiam does not practice medicine or manufacture, distribute, or sell any medications and has no relationship with any manufacturers or distributors of medications used in the PROMETA® Treatment Program. 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, the risk that treatment programs might not be effective, 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.
Source: Business Wire
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