Prometa

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Prometa is an integrated, physician-based treatment protocol for alcohol, cocaine or methamphetamine dependence licensed by Hythiam, Inc. The regimen “involves therapy and medications, both oral and intravenously injected,” according to an article in the New York Times magazine.[1]

While current studies are underway, it has been hypothesized that the Prometa treatment works by to decreasing anxiety and craving by addressing imbalances of the brain's receptors for GABA, a neurotransmitter.[1]

Contents

[edit] FDA approval status

Prometa has not been approved by the U.S. Food and Drug Administration for treatment of alcohol, cocaine or methamphetamine dependence nor has Hythiam requested approval.[2] According to CBS's investigative program 60 Minutes, the treatment is "being promoted by Terren Peizer, a former junk bond salesman whose business is business, not medicine. He skipped the usual medical research and government approvals to rush Prometa to market. Why the shortcuts? Peizer, who stands to make millions, says there's no way he can sit on Prometa when he believes it's the miracle treatment that millions are dying for."[2] However, some addiction scientists have criticized Hythiam for marketing it before it had been rigorously tested.[1]

[edit] Treatment steps

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.[3]

[edit] Controlled studies

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.[3]

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 most researchers consider more dependable. 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.[3]

60 Minutes reported that Dr. Urschel's addiction clinic sold the Prometa treatment. However Urschel denied this was a conflict of interest.[2]

Additionally, as of December 2007, 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.[4]
  • 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.[5]
  • Dr. Walter Ling of UCLA is conducting a 90-patient randomized, double-blind, placebo controlled study of Prometa for treatment of methamphetamine dependence.[4]
  • 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.[4]
  • 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.[4]

[edit] Pilot programs

In February 2006, Pierce County in Washington initiated a 40-person pilot program in association with the county's private nonprofit drug treatment center, Pierce County Alliance, to evaluate the efficacy of the Prometa program.[6] In October, 2007, after disclosures that elected officials and Alliance officers owned Hythiam stock,[7][2] an auditor's report concluded that the program was no more effective than other drug rehabilitation therapies.[8][2][9] This contradicted Alliance reports of significant progress resulting from different methods for measuring success than used by the auditors and country drug courts.[8] Hythiam had claimed that five other pilot programs existed. However, according to the audit report, these programs never existed, were terminated early or cancelled altogether.[10] Later that same month, the county commissioners ended funding for the program after spending $250,000.[10][2]

[edit] Cultural references

The treatment was featured on an episode of the MTV series True Life. A former methamphetamine addict named “Dustin” allowed the network to film his treatment with Prometa, for an episode called “I’m Going to Rehab”, as well as his life before and after he quit using methamphetamine.[11]

[edit] References

  1. ^ a b c Denizet-Lewis, Benoit (June 25, 2006). An Anti-Addiction Pill?. New York Times. Retrieved on 2007-12-09.
  2. ^ a b c d e f Pelley, Scott (December 9, 2007). Prescription For Addiction. 60 Minutes. Retrieved on 2007-12-09.
  3. ^ a b c 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". Mayo Clinic Proceedings 82: 1170–1178. Mayo Clinic. 
  4. ^ a b c d Prometa Ongoing Studies. Hythiam, Inc.. Retrieved on 2007-12-09.
  5. ^ ‘HANDS Protocol’ for alcoholism treatment to be tested in controlled clinical trial,” Alcoholism & Drug Abuse Weekly. Jul 11, 2005.
  6. ^ Clarridge, Christine (July 9, 2006). Pilot program helps ease drug addictions. The Seattle Times. Retrieved on 2007-12-10.
  7. ^ Otto, Alexander (October 24, 2007). Local officials owned stock in company. The News Tribune. Retrieved on 2007-12-10.
  8. ^ a b Robinson, Sean (November 11, 2007). Success or failure? Probing Prometa. The News Tribune. Retrieved on 2007-12-10.
  9. ^ Temmel, Matt (October 24, 2007). Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts (PDF). Pierce County Performance Audit Committee. Retrieved on 2007-12-10.
  10. ^ a b Otto, Alexander (October 24, 2007). Council cuts off drug program. The News Tribune. Retrieved on 2007-12-10.
  11. ^ Video: 2 of 6 True Life: I'm Going to Rehab. MTV (December 6, 2007). Retrieved on 2007-12-10.

[edit] External links