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-- Dr. Joseph Volpicelli and Dr. Jenny Sarosta of the Institute of Addiction Medicine are currently conducting a 60-patient randomized, double-blind, placebo controlled study of Prometa for alcohol dependence.<ref name="Hythiam" /> |
-- Dr. Joseph Volpicelli and Dr. Jenny Sarosta of the Institute of Addiction Medicine are currently conducting a 60-patient randomized, double-blind, placebo controlled study of Prometa for alcohol dependence.<ref name="Hythiam" /> |
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==Pilot programs== |
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In February 2006, [[Pierce County, Washington|Pierce County]] in [[Washington]] initiated a 40-person [[pilot program]] in partnership with the county's private nonprofit drug treatment center, Pierce County Alliance, to evaluate the [[efficacy]] of the Prometa program.<ref>{{cite web |
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|date=[[July 9]], [[2006]] |
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|author= Clarridge, Christine |
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|url= http://seattletimes.nwsource.com/html/localnews/2003114981_drugtreatment09m.html |
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|title= Pilot program helps ease drug addictions |
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|publisher= [[The Seattle Times]] |
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|accessdate=2007-12-10}}</ref> In October, 2007, after disclosures that elected officials and Alliance officers owned Hythiam stock, an [[auditor's report]] concluded that the program was no more effective than other drug rehabilitation therapies.<ref name="TNT111107">{{cite web |
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|date=[[November 11]], [[2007]] |
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|author= Robinson, Sean |
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|url= http://www.thenewstribune.com/news/local/story/200936.html |
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|title= Success or failure? Probing Prometa |
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|publisher= [[The News Tribune]] |
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|accessdate=2007-12-10}}</ref><ref name="60minutes" /><ref>{{cite web |
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|date=[[October 24]], [[2007]] |
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|author= Temmel, Matt |
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|coauthor= Vetter, William |
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|url= http://media.thenewstribune.com/smedia/2007/10/24/08/prometa_report.source.prod_affiliate.5.pdf |
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|format= PDF |
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|title= Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts |
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|publisher= Pierce County Performance Audit Committee |
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|accessdate=2007-12-10}}</ref> This contradicted Alliance reports of signficant progress resulting from different methods for measuring success than used by the auditors and country drug courts.<ref name="TNT111107" /> The audit report stated that five other pilot programs througout the country reported by Hythiam never existed, terminated early or were cancelled altogether.<ref name="TNT112407" /> Later that same month, the [[county commissioners]] ended funding for the program after spending $250,000.<ref name="TNT112407">{{cite web |
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|date=[[October 24]], [[2007]] |
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|author= Otto, Alexander |
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|url= http://www.thenewstribune.com/news/local/story/186324.html |
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|title= Council cuts off drug program |
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|publisher= [[The News Tribune]] |
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|accessdate=2007-12-10}}</ref><ref name="60minutes" /> |
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==Cultural references== |
==Cultural references== |
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Revision as of 17:41, 10 December 2007
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 GABA receptors, a neurotransmitter.[1]
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]
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.
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, a number of controlled studies of Prometa are currently underway at various hospitals and universities, including:
-- Dr. Urschel has just 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 currently conducting an 80-patient randomized, double-blind, placebo controlled study of Prometa for treatment of alcohol dependence.[5]
-- Dr. Walter Ling of UCLA is currently 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 currently 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 currently conducting a 60-patient randomized, double-blind, placebo controlled study of Prometa for alcohol dependence.[4]
Pilot programs
In February 2006, Pierce County in Washington initiated a 40-person pilot program in partnership 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, an auditor's report concluded that the program was no more effective than other drug rehabilitation therapies.[7][2][8] This contradicted Alliance reports of signficant progress resulting from different methods for measuring success than used by the auditors and country drug courts.[7] The audit report stated that five other pilot programs througout the country reported by Hythiam never existed, terminated early or were cancelled altogether.[9] Later that same month, the county commissioners ended funding for the program after spending $250,000.[9][2]
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.[10]
References
- ^ a b c Denizet-Lewis, Benoit (June 25, 2006). "An Anti-Addiction Pill?". New York Times. Retrieved 2007-12-09.
{{cite web}}: Check date values in:|date=(help) - ^ a b c d e Pelley, Scott (December 9, 2007). "Prescription For Addiction". 60 Minutes. Retrieved 2007-12-09.
{{cite web}}: Check date values in:|date=(help) - ^ a b Urschel, MD, MMA, Harold C. III (2007). "Open-Label Study of a Proprietary Treatment Program Targeting Type A γ-Aminobutyric Acid Receptor Dysregulation in Methamphetamine Dependence". Mayo Clinic Proceedings. 82. Mayo Clinic: 1170–1178. Retrieved 2007-12-09.
{{cite journal}}: Unknown parameter|coauthors=ignored (|author=suggested) (help)CS1 maint: multiple names: authors list (link) - ^ a b c d "Prometa Ongoing Studies". Hythiam, Inc. Retrieved 2007-12-09.
- ^ ‘HANDS Protocol’ for alcoholism treatment to be tested in controlled clinical trial,” Alcoholism & Drug Abuse Weekly. Jul 11, 2005.
- ^ Clarridge, Christine (July 9, 2006). "Pilot program helps ease drug addictions". The Seattle Times. Retrieved 2007-12-10.
{{cite web}}: Check date values in:|date=(help) - ^ a b Robinson, Sean (November 11, 2007). "Success or failure? Probing Prometa". The News Tribune. Retrieved 2007-12-10.
{{cite web}}: Check date values in:|date=(help) - ^ Temmel, Matt (October 24, 2007). "Effectiveness of Prometa Treatment Protocol in Pierce County Drug Courts" (PDF). Pierce County Performance Audit Committee. Retrieved 2007-12-10.
{{cite web}}: Check date values in:|date=(help); Unknown parameter|coauthor=ignored (|author=suggested) (help) - ^ a b Otto, Alexander (October 24, 2007). "Council cuts off drug program". The News Tribune. Retrieved 2007-12-10.
{{cite web}}: Check date values in:|date=(help) - ^ "Video: 2 of 6 True Life: I'm Going to Rehab". MTV. December 6, 2007. Retrieved 2007-12-10.
{{cite web}}: Check date values in:|date=(help)