Backers of the Prometa treatment regimen say it's a revolutionary approach to addiction therapy with eye-opening success rates, but critics say that hard data on the program is lacking, the Los Angeles Times reported Oct. 9.

Hythiam, the company that has developed and promotes Prometa, uses a trio of medications to treat addiction. Terren Peizer, CEO of the company, said the therapy is "changing the way we approach this disease."

But the company does not disclose details of the $15,000 regimen, which consists of two to five outpatient treatment sessions, and none of the drugs used -- flumazenil, gabapentin and hydroxyzine -- have been approved for addiction treatment. The medications all act of the gabaminergic system of the brain; patients also are given vitamins and minerals and encouraged to attend counseling and group support meetings.

Randomized studies comparing Prometa to other therapies or placebos have not been conducted. "They are using a procedure that has yet to be proven effective, charging an inordinate amount of money and making promises they are not able to keep," said Dr. Rick Chavez, medical director of the Pain Institute in Redondo Beach, Calif. Some addiction experts said that the claimed success of Prometa could be attributed to a placebo effect.

About 45 programs nationwide are licensed to deliver the Prometa treatment regimen, which has been around for about three years. A Pierce County, Wash., drug court, presenting data at the 2006 annual meeting of the National Association of Drug Court Professionals, claimed that 98 percent of clients addicted to methamphetamine or cocaine had three months of clean urines after undergoing the Prometa treatment. Another study claimed 80 percent of patients "experienced a significant clinical benefit" from the treatment.

Hythiam is now funding a pair of randomized, controlled studies on Prometa. But while that's commendable, said, Richard Rawson, a psychologist and associate director of UCLA's Integrated Substance Abuse Programs, "they should wait for the results before they do all the marketing. Between now and 2008, there is a lot of marketing going on. What if the results show it's no better than placebo?"

Editor's note: Read a related commentary regarding the Prometa treatment regimen.