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Intent-to-Treat Analysis of Double-Blind Methamphetamine Study Confirms Hythiam's PROMETA Treatment Program Showed Statistically Significant Reduction in Cravings Compared to Placebo

Posted on: Thursday, 19 June 2008, 09:01 CDT

Hythiam, Inc. (NASDAQ:HYTM) announced that the results of the first double-blind, placebo-controlled study utilizing Hythiam's PROMETA(R) Treatment Program (PROMETA) were presented yesterday at the College on Problems of Drug Dependence (CPDD) conference in San Juan, Puerto Rico, by addiction expert Harold C. Urschel, III, M.D., M.M.A. The 30-day study focused on evaluating the impact of PROMETA on cravings during the treatment of methamphetamine dependence, and was designed as a follow-up to Dr. Urschel's 90-day open-label study on the effects of PROMETA in treatment-seeking, methamphetamine-dependent individuals. The newly released results of the 30-day study were analyzed using an intent-to-treat analysis, which includes all randomized participants, and demonstrated that PROMETA achieved a statistically significant reduction in the combined craving score for methamphetamine when compared to placebo over the study duration. Non-parametric Mann-Whitney-Wilcoxon tests were used to compare the reduction in craving measures between the PROMETA and placebo groups, and missing cravings data were treated as missing (p=0.03). A separate analysis that assigns values for missing data by using multiple imputation procedure (PROC MI), which is a less conservative approach, was also statistically significant (p less than 0.0001). The PROMETA subjects also had an immediate and sustained reduction in cravings beginning with the first post-treatment assessment.

Outpatient subjects (n=135) must have used methamphetamine within 3 days prior to randomization: 68 received the pharmacologic component of PROMETA and 67 received placebo on days 1, 2, 3, 21 and 22 of the study. All subjects received psychosocial counseling and nutritional guidance. Drug craving, urine drug screens, and self-report of drug use were assessed. Cravings for methamphetamine were assessed at baseline and days 6, 13, 20 and 30.

Cravings are a significant predictive factor in relapse and use for patients in treatment for methamphetamine dependence.(1,2) Immediately following the first set of infusions, the change in combined craving score decreased by 54% for the PROMETA group, compared to a 35% decrease for placebo (p=0.006). A logistic regression model for this study also revealed that the combined craving score was a significant factor in predicting the probability of a positive urine drug screen and reported use. These results are clinically relevant and add to pre-existing literature about the correlation between cravings and use.

During the period of this 30-day study, urine drug screens and timeline follow-back self-reports assessed methamphetamine use. The intent-to-treat analysis utilized the worst-case-scenario, which counts missing data as positive for methamphetamine use. Across the duration of the study, the PROMETA subjects averaged a lower number of positive urine drug screens than the placebo group. On any given assessment day, the PROMETA subjects had a lower proportion of positive urine drug screens. An evaluation of the number of consecutive clean urines showed statistical significance in that 42% of the PROMETA subjects and 27% of placebo subjects had 2 consecutive clean urines during the 4 week study (p=0.03). Throughout the study, the PROMETA subjects had a lower frequency of self-reported use than the placebo group.

This double-blind, placebo-controlled study confirms the significant impact of the PROMETA Treatment Program on cravings, and a consistent trend toward decreased use during the initial treatment of methamphetamine dependent individuals who concurrently receive psychosocial therapy.

"The important relationship between cravings and use has been previously established in the literature, and the results of this double-blind, placebo-controlled study demonstrate how the PROMETA Treatment Program rapidly reduces cravings in a significant manner," said Hythiam's Senior Vice President of Scientific Affairs, Dr. Gary Ingenito. "Pharmacologic agents targeting GABA(A) receptor composition offer an additional, effective tool in treating methamphetamine dependence, and medications that mitigate cravings can enhance engagement and retention in psychosocial treatment. The results of this intent-to-treat analysis are clinically relevant, and we are not aware of any other methamphetamine study that has demonstrated a statistically significant reduction in cravings and a correlated reduction in use. We are excited about this data and look forward to the completion of additional studies this year."

"We look forward to peer-reviewed publication of this study as it will increase our ability to claim the benefits of PROMETA," said Hythiam's Chairman and CEO, Terren Peizer. "Our private-pay revenue to-date has not had the benefit of published double-blind placebo-controlled data, which will be vital to differentiating the value of PROMETA. The results of this study and others will continue to aid our efforts in securing managed care opportunities, and in expanding our private-pay revenue base."

References

1. Hartz DT, Frederick-Osborne SL., Galloway GP. Cravings predicts use during treatment for methamphetamine dependence: a prospective, repeated-measures, within-subject analysis. Drug and Alcohol Dependence. 2001;63:269-276. 2. Weiss RD, et al. The relationship between cocaine craving, psychosocial treatment, and subsequent cocaine use. Am J. Psychiatry; 2003;160:1320-1325.

About the PROMETA(R) Treatment Program

Hythiam's PROMETA Treatment Program is designed for use by health care 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(R)

Hythiam, Inc. provides, including through its CatasysTM offering, behavioral health management services to health plans, employers and unions through a network of licensed and company managed healthcare providers. CatasysTM offers integrated substance dependence solutions built around the patented PROMETA Treatment Program for alcoholism and dependence to stimulants. The PROMETA Treatment Program, which integrates behavioral, nutritional, and medical components, is available only through licensed treatment providers and company managed treatment centers. Hythiam also researches, develops, licenses and commercializes innovative and proprietary physiological, nutritional, and behavioral treatment programs. 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 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.

Source: Business Wire

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