DOUBLE-BLIND METHAMPHETAMINE STUDY CONFIRMS PROMETA TREATMENT PROGRAM SHOWED STATISTICALLY SIGNIFICANT REDUCTION IN CRAVINGS COMPARED TO PLACEBO

Hythiam, Inc. announced that the results of the first double-blind, placebo-controlled study utilizing Hythiam’s PROMETA® Treatment Program (PROMETA) that were presented June 18 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. 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 30-day study focused on evaluating the impact of PROMETA on cravings during the treatment of methamphetamine dependence. The results 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.

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.

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