Hythiam's Prometa Treatment Program Demonstrates Statistically Significant Reduction in Methamphetamine Cravings in Randomized, Double-Blind Placebo-Controlled Study
LOS ANGELES--(BUSINESS WIRE)--Nov 1, 2007 - Hythiam, Inc. (NASDAQ:HYTM) today announced statistically significant reduction in methamphetamine cravings with the PROMETA(R) Treatment Program, a primary study endpoint from a randomized, double-blind placebo-controlled study conducted by addiction expert and Board Certified Psychiatrist Harold C. Urschel, III, M.D., M.M.A. The 30-day study on cravings and neurocognition was designed as a follow-up to Dr. Urschel's 90-day open-label study on the effects of the PROMETA Treatment Program in treatment-seeking, methamphetamine-dependent subjects.A total of 134 patients, 67 for each treatment arm, were randomized in this trial and 88 (44 PROMETA Treatment Program, 44 placebo) completed the study protocol. Both groups received counseling during the study period. Results from the subjects who completed the study protocol demonstrated that the PROMETA Treatment Program was superior to placebo in reducing cravings for methamphetamine. All craving measures declined for both groups, however results for the PROMETA Treatment Program group were numerically superior to the placebo group at study end for all measures. More importantly, at the end of the 30-day treatment period, the PROMETA Treatment Program group was significantly superior to placebo for most measures, including the combined craving measure (P=0.0032) and strongest cravings (p=0.0069). Mean combined cravings score for the PROMETA treatment group decreased from 50.2 to 19.1, compared to reduction in the placebo group mean score from 48.7 at baseline to 27.8 at study end. For strongest cravings, the PROMETA group experienced a reduction from a baseline mean score of 9.3 to 3.7 at study end, and the placebo group mean score reduced from 9.0 to 5.7 at the last visit.
Cravings for methamphetamine in this trial were assessed at each data collection visit (Baseline and Days 4, 6, 13, 20, and 30) by having subjects provide an estimate of their peak craving for methamphetamine on a 10-point visual analogue scale (VAS), anchored at one end with "no craving for methamphetamine" and at the other end with "most intense craving for methamphetamine ever experienced."
"We are pleased to share our top-line findings on the reduction of cravings in methamphetamine-dependent subjects seeking-treatment," said principal investigator, Harold C. Urschel, III, M.D., M.M.A. "We believe this is the first study to show statistically significant reduction of cravings over placebo in treatment-seeking, methamphetamine-dependent subjects. These placebo-controlled outcomes confirmed the findings in our prior study, that there was indeed an immediate reduction of cravings within the one-month treatment period. In our prior study, we also observed a substantial and persistent reduction of meth use during the post-treatment follow-up period. Currently ongoing, longer-term randomized, placebo studies designed to elucidate the efficacy of the PROMETA Treatment Program against the primary endpoint of reduction of methamphetamine use will hopefully demonstrate this. The results of this study add to the growing body of evidence supporting clinical use of the PROMETA Treatment Program as a treatment option to address the persistent cravings that are so prevalent in stimulant-dependent individuals, in order to better allow them to participate in and benefit from behavioral aftercare."
Urschel continued, "I am also very excited to evaluate the neurocognitive data from this trial as well in the coming weeks, as I believe that we may see a significant, rapidly evolving cognitive improvement in the active arm of these methamphetamine addicts. We tentatively plan to present that data at the AAAP conference at the end of November."
The benefit of the PROMETA Treatment Program in decreasing methamphetamine cravings was demonstrated despite an anticipated magnified placebo response in this relatively short trial. Both treatment groups had significant reductions from baseline in cravings. The reduction for placebo may have been related to the intensity of treatment, the multiple medications administered, as well as attention and counseling that placebo subjects received during the 30-day study period. High placebo responses are particularly common in studies of psychotropic and analgesic medications, and are often related to patients' expectations and the high degree of attention that they receive from healthcare professionals in many trials.(1-4)
Self-reported methamphetamine use among patients who completed this study declined 60.8% from 89.5% of the 30 days prior to treatment, to 28.7% for the 30 days after the first visit among those in the PROMETA Treatment Program group and declined 49.6% from 83.1% to 33.5% in the placebo group. While not statistically significant, nine patients randomized to the PROMETA Treatment Program and six randomized to placebo were completely abstinent during the 30-day treatment period. The benefits of the PROMETA Treatment Program in decreasing both methamphetamine cravings and use are currently being evaluated in a second, ongoing, 120-day, randomized, double-blind placebo-controlled study being conducted by Walter Ling, M.D., and UCLA's Integrated Substance Abuse Program. This longer-term study will evaluate the effects of this therapy on cravings and post-treatment reduction of use for 90 days beyond the 30 day treatment period.
Results from a prior study have indicated that craving is a predictor of methamphetamine use in patients being treated for dependence on this drug.(5) It has even been suggested that clinicians should use VAS measurements of cravings to predict future methamphetamine abuse.(5) Intensity of cravings has also been shown to be correlated with relapse risk in patients being treated for cocaine dependence.(7)
"We are extremely pleased by this clinically relevant, top-line data from the first placebo-controlled study of the PROMETA Treatment Program," said Hythiam's Chairman and CEO Terren Peizer. "These results appear to validate the reports we have heard from our licensed physicians, treatment providers, patients, and their family members as to the rapidity with which the PROMETA Treatment Program is able to reduce cravings. Addressing cravings, which are believed to be a significant factor leading to relapse, provides an immediate benefit to the field of substance dependence treatment. These results will allow us to take a more proactive role in accelerating the adoption of PROMETA, and will provide hope to those suffering from addiction that there is a treatment available to address their suffering."
As previously referenced, Dr. Urschel's initial open-label study of the PROMETA Treatment Program demonstrated that this intervention significantly decreased methamphetamine use (P less than .001) at 84 days after the initiation of treatment versus 90 days before treatment.(6) In this study, where days with missing data are counted as days taking methamphetamine, the PROMETA Treatment Program still resulted in a 47% reduction in methamphetamine use. Among 36 subjects (72% of all those enrolled) who completed the 8-week evaluation phase, there was a 65% reduction in methamphetamine use and a 66% decrease in methamphetamine cravings (both P less than 0.001 versus pretreatment).(6)
The PROMETA Treatment Program, and other longer-term psychosocial treatments that have demonstrated modest efficacy(11-13) but which may be limited by poor patient retention and high relapse rates,(14) can potentially be integrated to promote long-term abstinence in the growing population with dependence on this drug.
The Company will hold a conference call at 7:30 a.m. PT (10:30 a.m. ET) today. Interested parties are invited to listen to the call live over the Internet at http://www.hythiam.com or http://www.vcall.com. The call is also available by dialing (877) 407-8031, or for international callers (201) 689-8031. A replay of the webcast will be available after the call on http://www.hythiam.com or http://www.vcall.com. A telephonic replay will also be available until 11:59 p.m. PT on November 8, 2007 by dialing (877) 660-6853 or (201) 612-7415, and entering account number 286 and the conference code 260468. -0-
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About the PROMETA(R) Treatment Program
Hythiam's PROMETA(R) 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(R) 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(R) 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(R) Treatment Program for alcoholism and dependence to stimulants. The PROMETA(R) Treatment Program, which integrates behavioral, nutritional, and medical components, is available through both licensed treatment providers and company managed PROMETA(R) 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(R) 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 risk 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.
Contact
Hythiam, Inc.
Ashely Anderson, 310-444-4343
Director, Corporate Communications
aanderson@hythiam.com
or
Media Relations:
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Tim Sullivan, 212-981-5234
tim_sullivan@dkcnews.com
