PROMETAT no more effective than placebo in reducing methamphetamine use

Wiley-BlackwellNov 15 2011

A recent study has found that PROMETAT, a popular but controversial treatment for methamphetamine addiction, is no more effective than placebo in reducing methamphetamine use, keeping users in treatment, or reducing cravings for methamphetamine. The study was funded by Hythiam, the company that owns the PROMETAT protocol, and is published online today in the scientific journal Addiction.

Methamphetamine, also known as meth, crystal meth, or ice, is the second most abused illicit drug in the world (cannabis is first), with 15-16 million regular users. The United States saw a rapid growth in methamphetamine addiction in the early 2000s. It was during that epidemic that PROMETAT burst onto the public scene through an aggressive marketing campaign.

Since its introduction, the PROMETAT protocol has been widely used in specialized private clinics in the U.S. as a treatment for methamphetamine addiction without going through the normal drug approval process. Normally, introducing a new medication requires approval by the U.S. Food and Drug Administration, including tests of product safety and a clinical trial to make sure the treatment produces the predicted effects. A loophole in this regulatory system allows a combination of previously approved medications to be marketed without review, whether or not the individual medications were originally approved as a treatment for the condition the new protocol targets. The manufacturer of PROMETAT, Hythiam, was therefore able to market and sell the new protocol with no federal review or clinical trial evidence.

Private patients reportedly pay $12,000 to $15,000 for one month of treatment.

Hythiam used some of its profits to fund the clinical trials long called for by the scientific community, including this one, designed and led by Dr. Walter Ling, a respected U.S. scientist and expert on methamphetamine addiction. Ling and his fellow researchers found that the group of participants given the PROMETAT treatment did not have better outcomes than those given placebo in terms of reducing methamphetamine use, retention in treatment, or reducing methamphetamine cravings.