Prometa is a controversial treatment protocol used primarily for methamphetamine addiction, although it has also been claimed to be effective for dependence on alcohol or cocaine. The treatment, based on the research of Spanish psychologist Juan Jose Legarda, involves a combination of three medications as well as therapy. Prometa was developed by Hythiam, Inc., which has sought to patent the protocol and charges up to $15,000 per patient to license its use. Lower rates are offered to the criminal justice system, where it has been used in several drug court pilot programs.
Prometa has been the subject of limited study, but is still awaiting the results of more thorough scientific study to determine its effectiveness. Hythiam has hypothesized that the treatment works to decrease anxiety and craving by "normalizing" GABA receptors (molecules in the brain that respond to neurotransmitters).
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.
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.
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 are more dependable, lacking any influence of cognitive bias. 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.
Additionally, as of December 2007[update], a number of controlled studies of Prometa are underway at various hospitals and universities, including:
- Dr. Urschel has 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.
- Dr. Jeffery Wilkins, vice chairman of Department of Psychiatry and Mental Health at Cedars-Sinai, is conducting an 80-patient randomized, double-blind, placebo controlled study of Prometa for treatment of alcohol dependence.
- Dr. Walter Ling of UCLA is conducting a 90-patient randomized, double-blind, placebo controlled study of Prometa for treatment of methamphetamine dependence.
- Dr. Raymond Anton of the Medical University of South Carolina, is conducting a 60-patient, randomized, double-blind,placebo controlled study of Prometa for treatment of alcohol dependence.
- Dr. Joseph Volpicelli and Dr. Jenny Sarosta of the Institute of Addiction Medicine are conducting a 60-patient randomized, double-blind, placebo controlled study of Prometa for alcohol dependence.
A Hythiam press release in 2004 announced that a center in Covington, Louisiana, would offer the treatment that was to become known as Prometa in that court's drug program. However, the program was never implemented, and the judge there said he was uncomfortable that the evidence for it was not as strong as the company's marketing. As a result, the first Prometa pilot took place in Gary, Indiana, beginning in November 2005. Hythiam provided a $50,000 grant to cover the program, and court officials spoke positively of the results, but were unable to secure funding to continue it after the grant ran out. Another trial in Fulton County, Georgia, ended early because it was not deemed effective; one report mentioned physician misconduct, but court officials would not comment about the issue.
Pierce County, Washington, initiated a 40-person pilot program in 2006 through a nonprofit treatment center serving the county's drug court, and officials reported very promising results. With this they were able to get $900,000 for Prometa funding in the state and county budgets for 2007, including a University of Washington study to evaluate the treatment. However, it was subsequently revealed that county executive John Ladenburg, state legislator Dennis Flannigan, and officials at the treatment center had bought Hythiam stock. A county audit also questioned the effectiveness of the program, in part because auditors took a different approach than the treatment center in determining whether Prometa was successful.
These revelations led the Pierce County Council to suspend its funding for the program in October 2007. An unspent $175,000, along with $400,000 Ladenburg had requested for 2008, were instead set aside with the proviso that they could be used for "evidence-based programs that are directed towards breaking the cycle of drug addiction". Ladenburg and Flannigan also had to amend their state financial disclosure forms, although Ladenburg reported he had sold his stock at a loss and insisted it did not influence his actions. The news from Pierce County, along with a 60 Minutes investigation of Prometa that aired in December, battered Hythiam's stock, as it fell in value nearly two-thirds by the end of the year. However, at the same time the city council in nearby Federal Way, Washington, approved a small $20,000 Prometa trial at the suggestion of a city council member whose employee, one of Prometa's successes, had been treated in Pierce County and featured in the 60 Minutes report.
Also in 2007, Jerry Madden, chair of the Texas House Corrections Committee, secured $2 million of funding over two years in the state budget for Prometa treatment programs. In contrast with officials in Washington, Madden said he had no financial ties to Hythiam. In support of the budget request he cited a 20-person pilot paid for by Hythiam in Collin County, where the local judge reported a "spectacular" success rate. Other courts in the state were more skeptical about the lack of clinical research supporting Prometa, however, and only four other counties requested funding. About half of the amount budgeted for the initial year was spent.
Popular culture connections
Troubled actress Lindsay Lohan was connected to Prometa as one of her rehab efforts during 2007, when Star Magazine reported that she was being treated by Dr. Matthew Torrington, director of the Prometa Center in Santa Monica. Prometa was also featured in an episode of the MTV series True Life, in which recovering methamphetamine addict "Dustin" allowed the network to film his treatment with Prometa, as well as his life before and after he quit using the drug.
- "Prescription For Addiction". 60 Minutes (CBS News). December 9, 2007. http://www.cbsnews.com/stories/2007/12/07/60minutes/main3590535.shtml. Retrieved 2008-08-22.
- Roan, Shari (October 9, 2006). "Addiction treatment, novel but unproved; Prometa's promoters point to anecdotal success. But critics want to see hard numbers". Los Angeles Times: p. F1.
- Denizet-Lewis, Benoit (June 25, 2006). "An Anti-Addiction Pill?". New York Times Magazine. http://www.nytimes.com/2006/06/25/magazine/25addiction.html. Retrieved 2008-08-22.
- Urschel, MD, MMA, Harold C. III; Larry L. Hanselka, PHD; Irina Gromov, MD, PHD; Lenae White, MD; Michael Baron, PHD (2007). "Open-Label Study of a Proprietary Treatment Program Targeting Type A γ-Aminobutyric Acid Receptor Dysregulation in Methamphetamine Dependence" ([dead link] – Scholar search). Mayo Clinic Proceedings (Mayo Clinic) 82 (10): 1170–1178. doi:10.4065/82.10.1170. PMID 17908523. http://www.mayoclinicproceedings.com/Abstract.asp?AID=4485&UID=&Abst=Abstract. Retrieved 2007-12-09.[dead link]
- "Hythiam - Completed and Ongoing Studies". Hythiam, Inc.. http://www.hythiam.com/ittrium/home/ProductsampServices/ThePROMETA174TreatmentProgram/CompletedandongoingStudies#ongoing. Retrieved 2009-02-02.[dead link]
- ‘HANDS Protocol’ for alcoholism treatment to be tested in controlled clinical trial,” Alcoholism & Drug Abuse Weekly. Jul 11, 2005.
- Robinson, Sean (December 23, 2007). "Data show mixed value of Prometa". The News Tribune.
- Clarridge, Christine (July 9, 2006). "Pilot program helps ease drug addictions". Seattle Times. http://seattletimes.nwsource.com/html/localnews/2003114981_drugtreatment09m.html. Retrieved 2008-08-25.
- Otto, M. Alexander (October 24, 2007). "Local officials owned stock in company". The News Tribune.
- Robinson, Sean (November 11, 2007). "Success or failure? Probing Prometa". The News Tribune.
- Otto, M. Alexander (October 24, 2007). "Council cuts off drug program". The News Tribune.
- Wickert, David (November 21, 2007). "Council rejects Prometa funding request". The News Tribune.
- Wickert, David (November 6, 2007). "Politicians revise stock disclosures". The News Tribune.
- Maynard, Steve (November 22, 2007). "In Federal Way, Prometa gets council support". The News Tribune.
- Ramshaw, Emily (January 20, 2008). "Texas' Prometa program for treating meth addicts draws skeptics". Dallas Morning News.
- "Lindsay's Shocking Drug Therapy". Star Magazine. October 24, 2007. http://www.starmagazine.com/news/13188. Retrieved 2008-08-22.
- "I'm Going to Rehab" (video). True Life. MTV. December 6, 2007. http://think.mtv.com/044FDFFFF0002D79C00170098BF0A/. Retrieved 2007-12-10.
- Prometa website
- Prometa Protocol for Alcohol Dependence - Clinicaltrials.gov listing for University of South Carolina study
- Prometa Pharmacotherapy for Methamphetamine Dependence - Clinicaltrials.gov listing for UCLA study
- Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts - Pierce County performance audit of Prometa program