Printer Friendly
The Free Library
14,669,765 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Acute and Immediate Impact of Hythiam's PROMETA(R) Protocols on Cravings and Cognition to Be Evaluated in Additional Double-Blind Placebo-Controlled Studies.


Renowned Alcoholism Researcher Dr. Joseph R. Volpicelli to Supervise Study of PROMETA([R]) on Alcohol Dependent Subjects; Dr. Harold C. Urschel III to Investigate Effects among Methamphetamine Dependent

LOS ANGELES Los Angeles (lôs ăn`jələs, lŏs, ăn`jəlēz'), city (1990 pop. 3,485,398), seat of Los Angeles co., S Calif.; inc. 1850.  -- 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 licenses the PROMETA([R]) treatment protocols designed to treat alcohol, methamphetamine and cocaine dependence, announced today that leading researchers will conduct additional studies to assess PROMETA's acute effects on reducing cravings and improving neurocognitive functioning. The Institute of Addiction Medicine's Dr. Jenny Starosta will conduct a double-blind placebo-controlled study designed and supervised by renowned alcoholism researcher, Dr. Joseph R. Volpicelli of the University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli.

http://upenn.edu/.

Address: Philadelphia, PA, USA.
, of the PROMETA protocol for the treatment of alcohol dependence. The second double-blind placebo-controlled study will be conducted by Dr. Harold C. Urschel III of Research Across America on the PROMETA protocol for methamphetamine dependence. This study is a follow up to Dr. Urschel's previously conducted single-arm, open-label study of PROMETA with 50 methamphetamine dependent subjects.

In addition to these two new studies, Hythiam is pending anticipated outcomes from three current clinical evaluations clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy  of the PROMETA protocols. Dr. Jeffrey Wilkins of Cedars-Sinai Hospital is conducting an open-label investigation of PROMETA for the treatment of alcohol dependence which he will follow up with a double-blind placebo-controlled study of PROMETA for alcohol dependence. Additionally, UCLA's Dr. Walter Ling and the Medical University of South Carolina's Dr. Raymond Anton are conducting randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind placebo-controlled studies of the PROMETA protocol for methamphetamine dependence and alcohol dependence, respectively.

"The two effects that have been observed repeatedly in evaluations of the PROMETA protocols have been reduced cravings and improved cognition," said Terren Peizer Terren Peizer is an American financier, the founder and currently the chairman and CEO of Hythiam, Inc., which provides behavioral health management services; researches, develops, licenses and commercializes behavioral treatment programs; and offers disease management for , Hythiam's Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . Third party payors have expressed great interest in these phenomena and these short-term studies will serve to provide them with definitive data on these two endpoints that are so critical to recovery. These near-term studies should complement the longer-term abstinence outcomes also expected in 2007 from investigations being conducted by Drs. Ling, Wilkins, and Anton.

Peizer continued, "Drs. Volpicelli, Starosta, and Urschel will focus on PROMETA's effects during the important phase of early abstinence, investigating immediate therapeutic benefit which could have an effect on the long-term prognosis of addictive disease. To date, there have been five separate sets of data from completely independent and unrelated entities that have provided compelling evidence supporting PROMETA's impact on sustained recovery. Retrospective analyses from PROMETA licensees Little Company of Mary and LifeWorks, pilot results from Gary, Indiana and the Pierce County Pierce County is the name of five counties in the United States:
  • Pierce County, Georgia
  • Pierce County, Nebraska
  • Pierce County, North Dakota
  • Pierce County, Washington
  • Pierce County, Wisconsin
 Alliance, and data from Dr. Harold Urschel's open label study have all demonstrated PROMETA's dramatic effect on recovery in geographically diverse populations comprised of patients dependent on different substances including cocaine, crack cocaine, alcohol, methamphetamine and poly-addictions of those substances."

"It is well known that alcoholic dependent individuals have cognitive deficits that interfere with memory, advance planning, and controlling impulses," said Dr. Volpicelli. "This combined with intense cravings that follow an individual's abstinence from alcohol are major contributors to relapse. Treatment that can normalize normalize

to convert a set of data by, for example, converting them to logarithms or reciprocals so that their previous non-normal distribution is converted to a normal one.
 these cognitive deficits and diminish cravings can facilitate recovery by improving treatment adherence, reducing urges to drink, resulting in overall improvement of abstinence outcomes. We are interested to see if PROMETA will immediately effect a patient's executive abilities and if it allows them to discern between positive and detrimental choices as they enter the critical first few weeks of recovery, during which time they are most vulnerable to relapse."

Dr. Volpicelli is an associate professor of psychiatry at the University of Pennsylvania, noted for pioneering the integration of medication with psychosocial support psychosocial support A nontherapeutic intervention that helps a person cope with stressors at home or at work. See Companionship, Most significant other.  to treat substance dependence. His research on the use of naltrexone naltrexone /nal·trex·one/ (nal-trek´son) an opioid antagonist used as the hydrochloride salt in treatment of opioid or alcohol abuse.

nal·trex·one
n.
An endorphin and narcotic antagonist.
 led to the first new medication to be approved by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 for alcohol treatment in nearly 50 years. Dr. Volpicelli developed a new model for psychosocial psychosocial /psy·cho·so·cial/ (si?ko-so´shul) pertaining to or involving both psychic and social aspects.

psy·cho·so·cial
adj.
Involving aspects of both social and psychological behavior.
 treatment based on techniques to enhance motivation and medication compliance called the BRENDA model.

Dr. Volpicelli's study will measure outcomes on 60 alcohol dependent subjects with a battery of standardized neurocognitive tests following treatment with the PROMETA protocol for alcohol dependence. Subjects will be randomly assigned to receive the PROMETA protocol or placebo. Tests will measure executive functioning In neuropsychology and cognitive psychology, executive functioning is the mental capacity to control and purposefully apply one's own mental skills. Different executive functions may include: the ability to sustain or flexibly redirect attention, the inhibition of inappropriate , verbal memory, general intelligence, and attention. Additional aims of the study are to determine the efficacy and safety of the PROMETA protocol by measuring alcohol craving, subject retention, percent of heavy drinking
  • Heavy drinking may mean drinking large amounts of water or alcohol.
  • Heavy drinking may also mean drinking alcohol to the point of Drunkenness.
 days, time to first heavy drinking day, and blood chemistries including liver enzymes and reports of side effects Side effects

Effects of a proposed project on other parts of the firm.
. The final aim of the study is to investigate in a preliminary way the characteristics of individuals who may be most likely to benefit from the PROMETA protocol for alcohol dependence.

Dr. Urschel's previous open-label study of methamphetamine dependent subjects found that more than 80% of study participants experienced a significant clinical benefit with no adverse events after treatment with the PROMETA protocol for methamphetamine. Clinical benefit was measured by decrease in cravings, increase in methamphetamine abstinent days, and treatment retention. In his current double-blind study double-blind study,
n experimental technique in clinical research in which neither the researcher nor the patient knows whether the treatment administered is considered inactive (placebo) or active (medicinal).
 of the PROMETA protocol for the treatment of methamphetamine dependence, 84 subjects will be followed for 30 days, half of whom will receive the PROMETA protocol with the other half receiving placebo.

"My ongoing interest in the PROMETA protocols is due to the impressive results we observed in our open label study of the PROMETA protocol with methamphetamine dependent subjects," said Dr. Urschel. "With this new randomized double-blind placebo controlled study, we hope to shed further light on PROMETA's potential to reduce cravings and restore neurocognitive function in persons addicted to methamphetamine during the important days and weeks following cessation of meth meth
n.
Methamphetamine hydrochloride.
 use."

The neurocognitive domains to be assessed among methamphetamine dependent include short-term memory short-term memory
n.
Abbr. STM The phase of the memory process in which stimuli that have been recognized and registered are stored briefly.
, concentration, executive function, and verbal learning. Standardized tests will be administered at baseline and days 4, 6, 13, 20, and 30 and will be used to compare PROMETA versus placebo improving the neurocognitive functioning of methamphetamine-dependent subjects during early abstinence. The study also aims to determine whether subjects treated with PROMETA have reductions in cravings and more drug-free days than subjects receiving placebo. PROMETA's efficacy on subjects' perceived disability and quality of life will be investigated as well as its effect on altering drug-related sexual practices.

About PROMETA([R])

Hythiam's PROMETA([R]) treatment protocols 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 PROMETA treatment protocols are an integrated treatment comprised of nutritional supplements Nutritional Supplements Definition

Nutritional supplements include vitamins, minerals, herbs, meal supplements, sports nutrition products, natural food supplements, and other related products used to boost the nutritional content of the diet.
, 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([R]) 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, nutritional, and behavioral treatment protocols that seek to address substance dependence. Additionally, Hythiam provides proprietary administrative services to assist physicians and facilities with staff education, training, marketing and outreach support, and outcomes tracking for data analysis. For further information, please click on 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 Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 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, the risk that treatment protocols 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Article Type:Clinical report
Date:Nov 7, 2006
Words:1368
Previous Article:2K Sports Announces NBA 2K7 and NHL 2K7 As Launch Day Titles for the PLAYSTATION(R)3 System.
Next Article:BondDesk Ranks in the "2006 Fast Five and SecuritiesTech 50".
Topics:



Related Articles
Selected Ongoing Clinical Trials [*].
[gamma]-Hydroxybutyric acid: a medicine or a drug of abuse? (Editorials).(Brief Article)
Self-medication with [gamma]-hydroxybutyrate to reduce alcohol intake.
Hythiam's PROMETA(TM) Protocol for Alcoholism to Be Evaluated towards Third-Party Reimbursement; Third Party Payor Provides Assurances That...
Does scientific evidence support the use of non-prescription supplements for treatment of acute menopausal symptoms such as hot flushes?(Review)
Study of PROMETA Protocol Shows Clinical Effectiveness; Statistically Significant Reduction in Methamphetamine Cravings and Methamphetamine Use.
Georgia's Fulton County to Evaluate Hythiam's PROMETA(R) Protocol for Stimulant Dependent Criminal Justice Population.
Treatment could turn into winner for both addicts and investors.(News & Analysis)
Drug treatment patent comes at prime time for Hythiam: award boosts plans for $26 million placement of common stock.(ADDICTION)
Protocol approval.(News of the Week)(to Hythiam Inc.)(Brief article)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles