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It has been touted as a wonder treatment — a way to reset the brain and curb the cravings that come with extended drug use.

It has also been called a marketing scheme without the needed science to support it.

The Prometa treatment, which uses a combination of three drugs to treat patients addicted to alcohol, cocaine and methamphetamine, has created its fair share of controversy.

At Stone Eagle Retreat in Malibu, patients are offered the treatment but don't have to take it. Those on staff at the rehabilitation center have created a partnership with The Prometa Center in Santa Monica because they say the treatment helps patients get beyond the physical demands of an addiction and frees them to focus on other psychological aspects.

Doug Szakacsy, the health and wellness director at Stone Eagle Retreat, acts as the liaison with The Prometa Center. He accompanies patients for their treatment.

"For people that really want to stop, I've seen it give them that control back," he said.

He also remembers thinking it was a wonder drug that was too good to be true when he first heard about it.

And that's the big problem with Prometa — there isn't a whole lot of proof of whether it's a wonder treatment or too good to be true.

The treatment isn't approved by the U.S. Food and Drug Administration. Instead, doctors who follow the protocol set up by the company behind Prometa use drugs that have been approved for other uses.

The patent held by the company behind Prometa focuses on the use of flumazenil to curb cocaine dependency. Flumazenil is FDA approved for counteracting the effects of sedation. Other drugs mentioned in the treatment are gabapentin, approved for treating neuropathic pain and epileptic seizures; and hydroxyzine, approved as a sedative and anti-anxiety treatment.

There has been criticism of the lack of FDA approval, but Dr. Matthew Torrington, medical director of The Prometa Center, said the treatment falls outside what the FDA regulates.

It approves drugs but doesn't tell doctors which drugs to use in which situations, he said.

"The FDA doesn't have a role to play," he said.

An FDA spokesman wrote in an e-mail: "FDA does not regulate the practice of medicine, so if physicians decide to use a certain treatment in connection with others, that is up to them."

The lack of studies leads to wariness in the medical community.

"Since there is so little known about it, there are really no significant data on its efficacy in the medical literature," Dr. Michael Turek, the medical director for the Ventura County Behavioral Health Department, wrote in an e-mail. "It is not a program that we at Ventura County Behavioral Health would be interested in."

In June 2006, the director of the National Institute on Drug Abuse discussed Prometa at a House subcommittee hearing.

Dr. Nora Volkow talked about how drug addiction is a disease that affects the brain and behavior. Because there is a belief that addiction treatment is not effective, it is important to provide objective evidence that such treatment works — and harmful to promote a treatment without evidence, she said.

"Do I support the utilization of treatments that are not evidence based? No, I do not," she said.

There have been a few studies, including one that was recently completed, that showed a reduction in cravings for meth patients using Prometa treatment when compared with a placebo.

Other studies are under way, including one at UCLA's Integrated Substance Abuse Program.

Dr. Walter Ling is heading the study, which started taking patients with meth addictions about a year ago and should start to yield some data by this summer.

"Our luck with treatment with methamphetamine addiction — especially in terms of effective medications — we just haven't had any real success up to now," he said.

"The proof of the pudding is in the eating," Ling said. "Instead of debating, why don't we put it to a test?"

Torrington said he eagerly awaits the outcomes of the studies, but said it would not be right to keep the treatment from patients during the slow pace of clinical study. The treatment has proven safe in previous studies, he said.

Prometa is licensed by Hythiam Inc. The company's average revenue per patient was $6,218 in the third quarter.

In November, Hythiam reported year-to-date revenues of $32.2 million and a net loss of $36.8 million.

The company's stock price has fallen from a 52-week high of $10.48 in January to hover around $3 most recently.