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New Clinical Study on the PROMETA Treatment Program for Meth Results
Research Across America conducted an open-label study of 50 people to evaluate the clinical effectiveness and safety of the PROMETA® Treatment Program for treating the methamphetamine-dependent population. In an open-label study, there is no placebo control, and both the researcher and participant know the full details of the treatment. This contrasts with "double-blind," placebo-controlled studies, where neither the participant nor the researcher knows if the participant is receiving the treatment or a placebo (e.g., a sugar pill). The reason for using blinding and placebo controls is to be able to know (as much as possible) if any benefits observed in the study are due to the treatment itself, and not other factors.
In this study, all of the participants were long-term (five- to ten-year) users of methamphetamine. This study was conducted at Research Across America, an outpatient clinical research center in Dallas, Texas. This outpatient setting allowed participants to remain in their existing environments, which replicated the real world of outpatient treatment, where people face environmental triggers that encourage drug use, such as contact with existing social networks of drug users. The physician-based and nutritional portions of the treatment were provided over a four-week period and participants were subsequently followed for eight weeks after the treatment was completed. This is an unusual design for drug abuse treatment trials. Unlike the standard PROMETA Treatment Program, participants in this study were not provided any specific psychosocial or drug abuse counseling during the study in order to evaluate as much as possible the impact of the physician-based and nutritional treatments alone.
Below is a brief description of the study results reported by Research Across America:
Overall, the treatment was well tolerated. No subject discontinued the treatment program because of side effects, and no serious adverse events occurred during any portion of the pharmacologic treatment. Below are the key findings:
36 out of 50 subjects completed the study. Among those 36 subjects, the average frequency of use dropped from 80% of days during the 90 days prior to the treatment, to 28% of the 84 days following the first infusion. This is a reduction of self-reported use-days of 65%.
Complete data on cravings was available for 31 subjects at 84 days. Of these, 30 subjects — 97% — reported a decrease in frequency of cravings, including 4 who reported zero cravings at study completion.
Among the 30 subjects whose cravings decreased, the mean reduction in cravings from the first visit to study completion was 66%.
Research Across America concluded that for the subjects in its study, the physician-based and nutritional components of the PROMETA Treatment Program:
Were safely administered in an outpatient setting.
Demonstrated clinical effectiveness, with chronic, relapsing methamphetamine-dependent patients significantly reducing methamphetamine usage up to 2 months after cessation of pharmacotherapy.
Were associated with side effects such as fatigue, dizziness, dry mouth, and unusual taste that were mild, transient, and generally well tolerated.
Were effective in increasing the number of methamphetamine- abstinent days and decreasing methamphetamine cravings.
We are very pleased by the results of this study, which is an important step in developing clinical data on the PROMETA Treatment Program. Additional ongoing studies include a multi-site, double-blind, placebo-controlled study on treatment of methamphetamine dependence being conducted by the University of California, Los Angeles (UCLA).
The PROMETA Treatment Program involves the use of prescription medications and nutritional supplements administered in a unique dosing algorithm, as well as psychosocial care. The medications used in the PROMETA Treatment Program are Food and Drug Administration (FDA) approved for uses other than treating dependence on alcohol, cocaine, or methamphetamine. Therefore, the risks and benefits of using those medications to treat dependence on those substances have not been evaluated by the FDA. Hythiam does not manufacture, distribute, or sell any medications, and has no relationship with any manufacturers or distributors of medications used in the PROMETA Treatment Program. Only a PROMETA-treating physician can determine if the PROMETA Treatment Program are appropriate for any individual patient.
In this study, all of the participants were long-term (five- to ten-year) users of methamphetamine. This study was conducted at Research Across America, an outpatient clinical research center in Dallas, Texas. This outpatient setting allowed participants to remain in their existing environments, which replicated the real world of outpatient treatment, where people face environmental triggers that encourage drug use, such as contact with existing social networks of drug users. The physician-based and nutritional portions of the treatment were provided over a four-week period and participants were subsequently followed for eight weeks after the treatment was completed. This is an unusual design for drug abuse treatment trials. Unlike the standard PROMETA Treatment Program, participants in this study were not provided any specific psychosocial or drug abuse counseling during the study in order to evaluate as much as possible the impact of the physician-based and nutritional treatments alone.
Below is a brief description of the study results reported by Research Across America:
Overall, the treatment was well tolerated. No subject discontinued the treatment program because of side effects, and no serious adverse events occurred during any portion of the pharmacologic treatment. Below are the key findings:
36 out of 50 subjects completed the study. Among those 36 subjects, the average frequency of use dropped from 80% of days during the 90 days prior to the treatment, to 28% of the 84 days following the first infusion. This is a reduction of self-reported use-days of 65%.
Complete data on cravings was available for 31 subjects at 84 days. Of these, 30 subjects — 97% — reported a decrease in frequency of cravings, including 4 who reported zero cravings at study completion.
Among the 30 subjects whose cravings decreased, the mean reduction in cravings from the first visit to study completion was 66%.
Research Across America concluded that for the subjects in its study, the physician-based and nutritional components of the PROMETA Treatment Program:
Were safely administered in an outpatient setting.
Demonstrated clinical effectiveness, with chronic, relapsing methamphetamine-dependent patients significantly reducing methamphetamine usage up to 2 months after cessation of pharmacotherapy.
Were associated with side effects such as fatigue, dizziness, dry mouth, and unusual taste that were mild, transient, and generally well tolerated.
Were effective in increasing the number of methamphetamine- abstinent days and decreasing methamphetamine cravings.
We are very pleased by the results of this study, which is an important step in developing clinical data on the PROMETA Treatment Program. Additional ongoing studies include a multi-site, double-blind, placebo-controlled study on treatment of methamphetamine dependence being conducted by the University of California, Los Angeles (UCLA).
The PROMETA Treatment Program involves the use of prescription medications and nutritional supplements administered in a unique dosing algorithm, as well as psychosocial care. The medications used in the PROMETA Treatment Program are Food and Drug Administration (FDA) approved for uses other than treating dependence on alcohol, cocaine, or methamphetamine. Therefore, the risks and benefits of using those medications to treat dependence on those substances have not been evaluated by the FDA. Hythiam does not manufacture, distribute, or sell any medications, and has no relationship with any manufacturers or distributors of medications used in the PROMETA Treatment Program. Only a PROMETA-treating physician can determine if the PROMETA Treatment Program are appropriate for any individual patient.
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