Prometa

Prometa is a controversial treatment protocol used primarily for methamphetamine addiction, although it has also been claimed to be effective for dependence on alcohol or cocaine. It is now being labeled as GABASYNC. The treatment, based loosely on the research of Spanish psychologist Juan Jose Legarda, involves a combination of three medications as well as therapy. The medications are each individually approved by the FDA, however none of which have been approved for addiction treatment by the FDA > further the combination has not received any FDA approval. The medications are Gabapentin, Flumazenil and hydroxyzine, used off label. Prometa was developed by Terren Peizer a former junk bond trader the company nameHythiam, Inc., which has sought to patent the protocol and charges up to $15,000 per patient to license its use. Lower rates are offered to the criminal justice system, where it has been used in several drug court pilot programs.

Other studies have found the prometa protocol to be no more effective than a placebo in regards to rates of recovery and reduction in craving.

A November, 2011, double-blind, placebo-controlled study published in the journal Addiction concluded that Prometa is ineffective. "The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving."

For alcohol dependence, the treatment consists of flumazenil (administered intravenously), hydroxyzine, and gabapentin. The treatment is similar for stimulant dependence, with additional flumazenil administrations. The dosing regimen of the drug combination is discussed in Urschel’s recently published study. The initial intravenous administrations are followed up by orally prescribed medications and behavioral treatment.

Preliminary evidence that a regimen combining hydroxizine, flumazenil and gabapentin - i.e. the active pharmacological components of Prometa - can help decrease methamphetamine cravings and use was first published in October 2007 following a relatively small, open-label trial by Dr. Harold C. Urschel. The study, funded by Hythiam, was published in the Mayo Clinic Proceedings, a peer reviewed medical journal.

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