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Methamphetamine Addiction Treatment Protocol Study Results: More Than 80% of Study Participants Experienced Significant Clinical Benefit

DALLAS, T.X. -- May 16, 2006 -- Research Across America, a nationally-recognized clinical research center, today announced initial results of their study of the Prometa(TM) treatment protocol for methamphetamine dependence.

Board Certified Psychiatrist and addiction expert Harold C. Urschel, III, MD, MMA, was lead investigator on this first clinical study of the Prometa treatment for stimulant dependence.

Initial results from this study showed no adverse events and that more than 80% of study participants experienced a significant clinical benefit. For purposes of determining clinical benefit, patient improvement was measured by treatment completion, study retention, reduction in cravings and decrease in usage of or abstinence from methamphetamine. Dr. Urschel will present full study results at the College on Problems of Drug Dependence's annual meeting in Scottsdale, AZ on June 21, 2006.

The study was conducted on an outpatient basis, with subjects remaining in an environment where they were subject to triggers that commonly cause methamphetamine cravings and usage. Despite this, the majority of patients were retained through the entire 12-week study. This is the first treatment for methamphetamine dependence to demonstrate a sustained post-treatment effect and continued improvement for patients beyond the medical phase, with sustained clinical improvement observed even at the end of the post-treatment nine-week follow-up period.

Although the Prometa treatment protocols include behavioral or drug abuse counseling component, this study included no behavioral interventions. Rather, the study focused on the medical component of the Prometa treatment protocols for methamphetamine dependence, which is designed to address neurological changes caused or worsened by addiction. This component comprises nutritional supplementation as well as FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm for the treatment of methamphetamine dependence. Behavioral treatment, however, is considered critical for ensuring long-term compliance with behavioral and lifestyle changes required for achieving sustained recovery.

"Methamphetamine is believed to be the one of the most addictive substances and one of the hardest dependencies to treat. Continued usage is neurotoxic and often results in psychosis, violent behavior, or even death. Until now, treatment options have been limited at best," said Dr. Urschel. He continued, "In our study, the Prometa treatment was clinically beneficial for methamphetamine dependent subjects, resulting in more than 80% of patients getting better. In addition to resulting in no adverse events, the treatment was well-tolerated as evidenced by the high patient retention rates in this study. In contrast to our clinical experience where most patients drop out of treatment in two to three days, almost all study subjects came back to receive the five required infusions over the course of 23 days. There was a significant clinical improvement for more than 80% of participants, as well as a decrease in usage of or abstinence from methamphetamine throughout the 12-week study."

Dr. Urschel added, "For years, I have observed the devastation and destruction wrought by the disease of methamphetamine addiction. Through this study, I observed unique aspects of Prometa that I believe make it a promising frontline treatment for methamphetamine addiction. The improvement was pronounced and sustained through the entire nine weeks of the follow-up period. A surprising and important observation was that many patients reported a considerable improvement in memory and concentration, decreased anxiety, and improved sleep patterns. Because our study contained no psychotherapy or drug abuse counseling, the results are focused on the medical aspects of Prometa. I believe, however, that when the entire Prometa treatment protocol, which include such behavioral components, are administered we will likely see further improved and sustained clinical benefit."

The study was conducted on 51 treatment-seeking men and women aged 18 to 65 years-old who met the criteria for methamphetamine dependent as defined by the Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV). Most participants were severely addicted and had been unable to remain abstinent for more than 24 hours prior when they enrolled in the study. Subjects participated in the study at the Research Across America clinical research facility in Dallas, TX.

Dr. Urschel is an accomplished researcher, clinician and recognized leader in addiction medicine who has designed and conducted studies for governmental agencies and major pharmaceutical companies. Dr. Urschel 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 (many as lead author) in journals and textbooks including Psychopharmacology Bulletin, Archives of General Psychiatry and the DSM-IV Sourcebook. He is also an Advisory Board Member for the Betty Ford Center Children's Program, a Psychiatric Consultant for the Salvation Army's Substance Abuse Treatment Program and a member of the Greater Dallas Council on Alcohol and Drug Abuse's speaker's bureau.

About Prometa and Hythiam
The Prometa treatment protocols are developed and licensed by Hythiam a healthcare services management company. Prometa represents an innovative approach to managing alcohol, cocaine or methamphetamine dependence or poly-addiction that is designed to address the physiological, nutritional and psychosocial aspects of these multi-factorial diseases, and is thereby intended to offer patients an opportunity to achieve sustained recovery.

The Prometa treatment protocols comprise nutritional supplements, as well as FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm combined with psychosocial or other recovery-oriented therapy chosen by the patient in conjunction with their treatment provider. For further information, please visit www.prometainfo.com.


SOURCE: Research Across America

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