Study Finds Prometa Treatment Ineffective

A recent study, published online in the scientific journal Addiction on November 14, 2011, has found that PROMETA™, a 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 PROMETA™ protocol.

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 PROMETA™ burst onto the public scene through an aggressive marketing campaign.

Since its introduction, the PROMETA™ 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 PROMETA™, 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.

In 2006, several CSAM members voiced strong concerns that the marketing for this treatment was ahead of the evidence for both its safety and efficacy. While not every form of treatment can be researched with protocols that meet the gold standard for credible evidence, CSAM communicated the principle that those products and protocols that can be researched at high levels of evidence-credibility should be, before their benefits are promoted and adopted as proven forms of treatment. CSAM urged physicians to use caution when recommending unproven treatments for substance abuse. CSAM published a “Statement of CSAM Principles Regarding Evidence-Based Medicine.”

Hythiam used some of its profits to fund the clinical trials including this one, designed and led by CSAM member Walter Ling, MD, an expert on methamphetamine addiction. Ling and his fellow researchers found that the group of participants given the PROMETA™ treatment did not have better outcomes than those given placebo in terms of reducing methamphetamine use, retention in treatment, or reducing methamphetamine cravings.

Ling W., Shoptaw S., Hillhouse M., Bholat M.A., Charuvastra C., Heinzerling K., Chim D., Annon J, and Doraimani G. Double-blind placebo-controlled evaluation of the PROMETA™ Protocol for methamphetamine dependence. Addiction, 106: doi:10.1111/j.1360-0443.2011.03619.x