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.
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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."
Treatment steps
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.
Controlled studies
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.
60 Minutes reported that Dr. Urschel's addiction clinic sold the Prometa treatment. However Urschel denied this was a conflict of interest.
Dr. Urschel has also completed a double-blind, placebo controlled study of Prometa's active ingredients, where 68 patients were randomized to active and 67 patients to placebo treatment for 30 days. The study reported a decrease in both cravings and methamphetamine use following the initial treatment and throughout the 30 days treatment period.
The effects of the flumazenil/gabapentin combination in the treatment of alcohol dependence are less clear. In a randomized, placebo-controlled trial alcohol-dependent subjects taking flumazenil/gabapentin had more abstinent days and time to first heavy drinking if they had high alcohol withdrawal symptoms prior to treatment, whereas the patients with low withdrawal symptoms actually did worse with active treatment.
Pilot programs
A Hythiam press release in 2004 announced that a center in Covington, Louisiana, would offer the treatment that was to become known as Prometa in that court's drug program. However, the program was never implemented, and the judge there said he was uncomfortable that the evidence for it was not as strong as the company's marketing. As a result, the first Prometa pilot took place in Gary, Indiana, beginning in November 2005. Hythiam provided a $90,000 grant(according to Karen Freeman-Wilson on a radio show with Gary's 1370am http://www.ustream.tv/channel/wlth-talk on 4/22/11) to cover the program, and court officials spoke positively of the results, but were unable to secure funding to continue it after the grant ran out. Another trial in Fulton County, Georgia, ended early because it was not deemed effective; one report mentioned physician misconduct, but court officials would not comment about the issue.
Pierce County, Washington, initiated a 40-person pilot program in 2006 through a nonprofit treatment center serving the county's drug court, and officials reported very promising results. With this they were able to get $900,000 for Prometa funding in the state and county budgets for 2007, including a University of Washington study to evaluate the treatment. However, it was subsequently revealed that county executive John Ladenburg, state legislator Dennis Flannigan, and officials at the treatment center had bought Hythiam stock. A county audit also questioned the effectiveness of the program, in part because auditors took a different approach than the treatment center in determining whether Prometa was successful.
These revelations led the Pierce County Council to suspend its funding for the program in October 2007. An unspent $175,000, along with $400,000 Ladenburg had requested for 2008, were instead set aside with the proviso that they could be used for "evidence-based programs that are directed towards breaking the cycle of drug addiction". Ladenburg and Flannigan also had to amend their state financial disclosure forms, although Ladenburg reported he had sold his stock at a loss and insisted it did not influence his actions. The news from Pierce County, along with a 60 Minutes investigation of Prometa that aired in December, battered Hythiam's stock, as it fell in value nearly two-thirds by the end of the year. However, at the same time the city council in nearby Federal Way, Washington, approved a small $20,000 Prometa trial at the suggestion of a city council member whose employee, one of Prometa's successes, had been treated in Pierce County and featured in the 60 Minutes report.
Also in 2007, Jerry Madden, chair of the Texas House Corrections Committee, secured $2 million of funding over two years in the state budget for Prometa treatment programs. In contrast with officials in Washington, Madden said he had no financial ties to Hythiam. In support of the budget request he cited a 20-person pilot paid for by Hythiam in Collin County, where the local judge reported a "spectacular" success rate. Other courts in the state were more skeptical about the lack of clinical research supporting Prometa, however, and only four other counties requested funding. About half of the amount budgeted for the initial year was spent.
Popular culture connections
Troubled actress Lindsay Lohan was connected to Prometa as one of her rehab efforts during 2007, when Star Magazine reported that she was being treated by Dr. Matthew Torrington, director of the Prometa Center in Santa Monica. Prometa was also featured in an episode of the MTV series True Life, in which recovering methamphetamine addict "Dustin" allowed the network to film his treatment with Prometa, as well as his life before and after he quit using the drug.