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NEW YORK STATE OFFICE OF ALCOHOLISM AND SUBTANCE ABUSE SERVICES
Addition Services for Prevention, Treatment, Recovery

Addiction Medicine FYI

Prometa

In response to questions OASAS is receiving related to a program which aired on CBS “60 Minutes” on 12/9/07 regarding a “New Addiction Treatment”, PROMETA,  we are sending the following information which is a summary of a report issued by the NYS OASAS Commissioner’s Medical Advisory Panel on March 2, 2006.

Background: Hythiam® is a healthcare services management company, focused on delivering solutions for those suffering from alcoholism and other substance dependencies. Hythiam researches, develops, licenses, and commercializes innovative physiological treatment protocols. Hythiam does not provide medical advice, diagnosis or treatment.

Based in Los Angeles, California, Hythiam is currently licensing its proprietary PROMETA™ treatments to hospitals, drug treatment centers, physicians, and major medical systems throughout the United States in collaboration with the Health Alliance Network and CompCare. It appears that the Hythiam system was developed by the same physician who developed the ultrarapid opiate detox procedure and marketed it.

PROMETA is advertised as a “promising new medical treatment approach for the management of alcohol and stimulant (cocaine and methamphetamine) dependence and it  may be used in all stages of the recovery process and can complement existing addiction treatments.”

PROMETA  Protocol:

The treatment involves prescription medications and nutritional supplements that are administered in a proprietary manner. The medical treatment is followed by continuing care, such as individual and/or group therapy, which is considered a key part of recovery.

The treatment begins with a brief 2-3 day course of prescription medications flumazenil (IV), gabapentin, atarax and nutritional supplements. Some patients may require a third day of treatment, and it will be up to the treating physician to make this decision during the course of treatment.  This is followed by a brief course of at-home medications and nutritional supplements taken for approximately one month.  Treatment takes place at a hospital facility or clinic that has licensed the rights to use PROMETA.

During treatment with PROMETA, the patient will receive:

  • A comprehensive physical exam
  • Medical supervision
  • Medications and nutrients
  • Information about follow-up and continuing care
  • Treatment with PROMETA involves prescription drugs. These medications are Food and Drug Administration (FDA) approved for uses other than substance dependence, but they have not been approved for use in treating Cocaine Dependence.
  • Continuing Care - following the initial medical treatment of 2-3 consecutive days, patients participate in continuing care, such as counseling or group support, which is considered an essential part of the recovery process.

While the effectiveness of the PROMETA treatment protocols has not yet been proven, clinical studies are underway. There are currently over 25 centers in the US now offering PROMETA and 330 patients have undergone treatment so far. In NYS, Parallax, an OASAS certified program, is using PROMETA.

The Medical Advisory Panel members had information that the PROMETA package costs $15,000 with half going to the provider and half going to the company.

OASAS MEDICAL ADVISORY PANEL POSITION:

  1. It is impossible to know if PROMETA will save the state money, as there has been no long term data published on follow-up and relapse. Most of the presented information and data did not track patients after 4 months.
  2. There has been no published research in peer reviewed medical journals to date.
  3. This should not be considered a detoxification protocol as it is given after detoxification has been completed.
  4. The usual detoxification medications, the Benzodiazepine group, cannot be used concurrently with PROMETA and in fact, it is suggested that protocols do not use Benzodiazepines but rather Phenobarbital so as not to have adverse reactions caused by the Flumazenil.
  5. Some members were concerned that it is not clear how the medication part of the protocol works on receptors, though it was noted that we do not know how many medications work definitively.
  6. We feel that we cannot offer an opinion for or against PROMETA until there are longer range, controlled studies and research publications in peer reviewed journals. These pilot studies should be carried out with IRB (institutional review board) approval.

12/10/07