prometa

Prometa
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Prometa is an integrated, physician-based treatment protocol for alcohol, cocaine or methamphetamine dependence licensed by Hythiam, Inc. The regimen "involves therapy and medications, both oral and intravenously injected," according to an article in the New York Times magazine.[1]

While current studies are underway, it has been hypothesized that the Prometa treatment works by to decreasing anxiety and craving by addressing imbalances of the brain's GABA receptors, a neurotransmitter.[1]

Contents
1 FDA approval status
2 Treatment steps
3 Controlled studies
4 Cultural references
5 References
6 External links



[edit] FDA approval status
Prometa has not been approved by the U.S. Food and Drug Administration for treatment of alcohol, cocaine or methamphetamine dependence nor has Hythiam requested approval.[2] According to CBS's investigative program 60 Minutes, the treatment is "being promoted by Terren Peizer, a former junk bond salesman whose business is business, not medicine. He skipped the usual medical research and government approvals to rush Prometa to market. Why the shortcuts? Peizer, who stands to make millions, says there's no way he can sit on Prometa when he believes it's the miracle treatment that millions are dying for."[2] However, some addiction scientists have criticized Hythiam for marketing it before it had been rigorously tested.[1]


[edit] 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.


[edit] Controlled studies
An October 2007 peer-reviewed study led by Dr. Harold C. Urschel, funded by Hythiam, and published in the Mayo Clinic Proceedings medical journal, examined the pharmacological component of Prometa for methamphetamine dependence.[3]

The 50-patient study was an open-label trial, meaning it lacked a control group using a placebo, and both clinicians and patients knew that Prometa was being tested. This contrasts with double-blind studies which most researchers consider more dependable. The study found that "Substantial reductions in methamphetamine cravings and use were observed in all phases of treatment, and the retention rate of participants was high" and recommended that the protocol be tested in controlled, double-blind trials.[3]

60 Minutes reported that Dr. Urschel's addiction clinic sold the Prometa treatment. However Urschel denied this was a conflict of interest.[2]

Additionally, a number of controlled studies of Prometa are currently underway at various hospitals and universities, including:

-- Dr. Urschel has just completed a second study of Prometa, as a follow up to his published study. The second study was an 84-patient randomized, double-blind, placebo controlled study of Prometa for the treatment of methamphetamine cravings. The study is awaiting publication.[4]

-- Dr. Jeffery Wilkins, vice chairman of Department of Psychiatry and Mental Health at Cedars-Sinai, is currently conducting an 80-patient randomized, double-blind, placebo controlled study of Prometa for treatment of alcohol dependence.[5]

-- Dr. Walter Ling of UCLA is currently conducting a 90-patient randomized, double-blind, placebo controlled study of Prometa for treatment of methamphetamine dependence.[4]

-- Dr. Raymond Anton of the Medical University of South Carolina, is currently conducting a 60-patient, randomized, double-blind,placebo controlled study of Prometa for treatment of alcohol dependence.[4]

-- Dr. Joseph Volpicelli and Dr. Jenny Sarosta of the Institute of Addiction Medicine are currently conducting a 60-patient randomized, double-blind, placebo controlled study of Prometa for alcohol dependence.[4]


[edit] Cultural references
The treatment was featured on an episode of the MTV series True Life. A former methamphetamine addict named "Dustin" allowed the network to film his treatment with Prometa, for an episode called "I'm Going to Rehab", as well as his life before and after he quit using methamphetamine.[6]


[edit] References
CHICAGO ― A costly drug cocktail touted as the first pharmacological treatment for cocaine and methamphetamine addiction is at the center of a national debate.

The treatment, Prometa, is not approved by the Food and Drug Administration (FDA) as an addiction therapy, nor has it undergone extensive scientific testing.

But officials at Hythiam, the Los Angeles company that sells the treatment protocol, said it can work miracles for people struggling to break their addiction.

David Smart, of Federal Way, turned to Prometa when he hit rock bottom eight months ago. Smart had lost everything: his wife, his family, his job and his home.

By his estimate, he had failed at least two dozen times to overcome his methamphetamine addiction.

"I had tried everything, and nothing worked for me," said Smart, 41. "But Prometa has."

Mario Acosta Jr. also tried Prometa but relapsed within days of completing treatment.

"They told me it would work for everything," said Acosta, 44, a San Pedro, Calif., longshoreman who was battling alcoholism and heroin addiction.

He took out a $5,000 loan to help pay for it. "What a waste of money that was," he said.

As many as 3,000 people have tried Prometa, up from about 1,000 a year ago, a Hythiam spokesman said. Prometa first was offered in 2003 as the HANDS Protocols.

In addition to the drug cocktail that is the focus of the therapy, the treatment includes nutritional supplements and counseling.

But some treatment professionals said the company rushed to treat patients with Prometa before it had undergone greater scrutiny.

"I don't think Prometa is a drug treatment for addiction; I think it's a marketing scheme," said Dr. Alex Stalcup, a California expert on methamphetamine addiction.

Some addiction experts said the treatment is reminiscent of controversial methods promoted in the past.

"There is an attempt to create hype before there is actual evidence, make a buck and move on," said Chicago addiction specialist Dr. David Ostrow, who attended a meeting here organized by Hythiam last month.

Hythiam officials said the company's attention-grabbing marketing shouldn't be confused with its treatment.

"People are dying [from drug abuse], and this [treatment] seems to be making a dramatic difference," said Dr. Matthew Torrington, medical director of the Prometa Center in Santa Monica, Calif., one of four such treatment centers.

Jim Pickett, chairman of the Chicago Crystal Meth Task Force, said Hythiam is pushing an untested treatment on people when they are at their lowest point. His outrage grew after he saw a full-page ad for Prometa in Gay Chicago Magazine.

"They are preying on vulnerable people," Pickett said. "People in the throes of crystal-meth addiction ― and their families ― are extremely vulnerable, and they are taking advantage of it."

Millions affected

Last year, an estimated 23 million Americans abused or were dependent on alcohol, illegal drugs or prescription medication, according to the federal Substance Abuse and Mental Health Services Administration. About 2.5 million sought help at specialty treatment facilities.

Experts agree controversy over Prometa has highlighted the need for effective medical treatments for addiction, especially for those hooked on meth, which has become a scourge in many rural areas. So far, the FDA has approved four drugs to treat alcoholism and three drugs to treat addiction to opiates.

It is Prometa's cocktail of three medications ― flumazenil, gabapentin and hydroxyzine ― that is generating controversy.

Flumazenil reverses the sedative effects of general anesthesia and is used to treat overdoses caused by benzodiazepines such as Valium. Gabapentin is an antiseizure medication. Hydroxyzine, an antihistamine, also is used to treat anxiety.

The drug cocktail is being used "off label," meaning the medications have been approved by the FDA to treat other disorders, but not addiction.

Hythiam doesn't own or manufacture the drugs but said it owns the treatment protocol.

The protocol has been studied in three company-funded clinical trials. Two open-label studies reported fewer days of meth use and reduced cravings. Open-label studies are considered preliminary research.

A third study reported reduced cravings among Prometa users at the end of 30 days of treatment, compared with those who took a placebo. That study of Prometa was its first randomized, double-blind, placebo-controlled trial, considered the gold standard of medical research.

Critics question focus

Critics said the results were unimpressive and scoffed at the focus on self-reported cravings instead of drug abstinence.

"Everyone wants to see abstinence," said Dr. Harold Urschel, chief executive of the Urschel Recovery Science Institute in Dallas, which conducted the research. Urschel also treats patients with Prometa under a licensing agreement with the company. "But that's just one factor in treatment success."

Company officials said additional studies under way will confirm the treatment's effectiveness. Results from a study being conducted at UCLA are expected as early as next year.

Hythiam has opened treatment centers in Santa Monica, San Francisco, New Jersey and Florida, with plans to open more. Alcoholism treatment costs $13,000; cocaine and meth treatment costs $15,000.

Private insurance doesn't cover Prometa, but Blue Cross Blue Shield plans in New York and New Jersey might do so, a Hythiam spokesman said.

The company also is seeking public funding to cover treatment of Medicaid patients, parolees and others. In the company's last annual report, Chief Executive Terren Peizer said the company could eventually treat up to 5 million people in criminal-justice programs.

Criticism of such programs has mounted in recent weeks.

Last month, the Pierce County Council in Tacoma voted to end its funding of a Prometa pilot project for drug offenders after a report by county auditors concluded that there was no evidence that it worked. The company said the report was politically motivated.

Also last month, the Federal Way City Council approved spending $20,000 for a trial of the Prometa program.