Prometa
Encyclopedia
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.
A November, 2011, double-blind, placebo-controlled study published in the journal Addiction concluded that Prometa is ineffective. "The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving."
(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.
by Dr. Harold C. Urschel. The study, funded by Hythiam, was published in the Mayo Clinic Proceedings, a peer reviewed medical journal.
60 Minutes reported that Dr. Urschel's addiction clinic sold the Prometa treatment. However Urschel denied this was a conflict of interest
.
Dr. Urschel has also completed a double-blind, placebo controlled study of Prometa's active ingredients, where 68 patients were randomized to active and 67 patients to placebo treatment for 30 days. The study reported a decrease in both cravings and methamphetamine use following the initial treatment and throughout the 30 days treatment period..
The effects of the flumazenil/gabapentin combination in the treatment of alcohol dependence are less clear. In a randomized, placebo-controlled trial alcohol-dependent subjects taking flumazenil/gabapentin had more abstinent days and time to first heavy drinking if they had high alcohol withdrawal symptoms prior to treatment, whereas the patients with low withdrawal symptoms actually did worse with active treatment.
, 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 $90,000 grant(according to Karen Freeman-Wilson on a radio show with Gary's 1370am http://www.ustream.tv/channel/wlth-talk on 4/22/11) 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.
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.
Methamphetamine
Methamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...
addiction, although it has also been claimed to be effective for dependence
Physical dependence
Physical dependence refers to a state resulting from chronic use of a drug that has produced tolerance and where negative physical symptoms of withdrawal result from abrupt discontinuation or dosage reduction...
on alcohol
Alcohol
In chemistry, an alcohol is an organic compound in which the hydroxy functional group is bound to a carbon atom. In particular, this carbon center should be saturated, having single bonds to three other atoms....
or cocaine
Cocaine
Cocaine is a crystalline tropane alkaloid that is obtained from the leaves of the coca plant. The name comes from "coca" in addition to the alkaloid suffix -ine, forming cocaine. It is a stimulant of the central nervous system, an appetite suppressant, and a topical anesthetic...
. 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
Drug court
Drug Courts are judicially supervised court dockets that handle the cases of nonviolent substance abusing offenders under the adult, juvenile, family and tribal justice systems...
pilot programs.
A November, 2011, double-blind, placebo-controlled study published in the journal Addiction concluded that Prometa is ineffective. "The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving."
Treatment steps
For alcohol dependence, the treatment consists of flumazenilFlumazenil
Flumazenil is a benzodiazepine antagonist available for injection only, and the only benzodiazepine receptor antagonist on the market today.It was first introduced in 1987 by Hoffmann-La Roche under the trade name Anexate, but only approved by...
(administered intravenously), hydroxyzine
Hydroxyzine
Hydroxyzine is a first-generation antihistamine of the diphenylmethane and piperazine classes. It was first synthesized by Union Chimique Belge in 1956 and was marketed by Pfizer in the United States later the same year, and is still in widespread use today....
, and gabapentin
Gabapentin
Gabapentin is a pharmaceutical drug, specifically a GABA analogue. It was originally developed for the treatment of epilepsy, and currently is also used to relieve neuropathic pain...
. 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
Preliminary evidence that a regimen combining hydroxizine, flumazenil and gabapentin - i.e. the active pharmacological components of Prometa - can help decrease methamphetamine cravings and use was first published in October 2007 following a relatively small, open-label trialOpen-label trial
An open-label trial or open trial is a type of clinical trial in which both the researchers and participants know which treatment is being administered....
by Dr. Harold C. Urschel. The study, funded by Hythiam, was published in the Mayo Clinic Proceedings, a peer reviewed medical journal.
60 Minutes reported that Dr. Urschel's addiction clinic sold the Prometa treatment. However Urschel denied this was a conflict of interest
Conflict of interest
A conflict of interest occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other....
.
Dr. Urschel has also completed a double-blind, placebo controlled study of Prometa's active ingredients, where 68 patients were randomized to active and 67 patients to placebo treatment for 30 days. The study reported a decrease in both cravings and methamphetamine use following the initial treatment and throughout the 30 days treatment period..
The effects of the flumazenil/gabapentin combination in the treatment of alcohol dependence are less clear. In a randomized, placebo-controlled trial alcohol-dependent subjects taking flumazenil/gabapentin had more abstinent days and time to first heavy drinking if they had high alcohol withdrawal symptoms prior to treatment, whereas the patients with low withdrawal symptoms actually did worse with active treatment.
Pilot programs
A Hythiam press release in 2004 announced that a center in Covington, LouisianaCovington, Louisiana
Covington is a city in and the parish seat of St. Tammany Parish, Louisiana, United States. The population was 8,483 at the 2000 census. It is located at a fork of the Bogue Falaya and the Tchefuncte River....
, 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
Gary, Indiana
Gary is a city in Lake County, Indiana, United States. The city is in the southeastern portion of the Chicago metropolitan area and is 25 miles from downtown Chicago. The population is 80,294 at the 2010 census, making it the seventh-largest city in the state. It borders Lake Michigan and is known...
, beginning in November 2005. Hythiam provided a $90,000 grant(according to Karen Freeman-Wilson on a radio show with Gary's 1370am http://www.ustream.tv/channel/wlth-talk on 4/22/11) 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
Fulton County, Georgia
Fulton County is a county located in the U.S. state of Georgia. Its county seat is Atlanta, the state capital since 1868 and the principal county of the Atlanta metropolitan area...
, 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
Pierce County, Washington
right|thumb|[[Tacoma, Washington|Tacoma]] - Seat of Pierce CountyPierce County is the second most populous county in the U.S. state of Washington. Formed out of Thurston County on December 22, 1852, by the legislature of Oregon Territory...
, 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
University of Washington
University of Washington is a public research university, founded in 1861 in Seattle, Washington, United States. The UW is the largest university in the Northwest and the oldest public university on the West Coast. The university has three campuses, with its largest campus in the University...
study to evaluate the treatment. However, it was subsequently revealed that county executive John Ladenburg
John Ladenburg
John W. Ladenburg was appointed to the Tacoma City Council in 1982 and elected to a full term in 1984. He was elected Pierce County Prosecuting Attorney in 1986, defeating incumbent Bill Griffies. Ladenburg was reelected Prosecuting Attorney three times, becoming the first person to be elected to...
, 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
60 Minutes
60 Minutes is an American television news magazine, which has run on CBS since 1968. The program was created by producer Don Hewitt who set it apart by using a unique style of reporter-centered investigation....
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
Federal Way, Washington
Federal Way is a city in King County, Washington, United States. Federal Way is located between Seattle and Tacoma. Its western boundary is Puget Sound. It is bordered by Des Moines on the north, Kent, unincorporated King County, and Milton on the east and Tacoma and Fife on the south...
, 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
Collin County, Texas
As of the census of 2000, there were 491,675 people, 181,970 households, and 132,292 families residing in the county. The population density was 580 people per square mile . There were 194,892 housing units at an average density of 230 per square mile...
, 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 LohanLindsay Lohan
Lindsay Lohan is an American actress, pop singer and model. She began her career as a child fashion model before making her motion picture debut in Disney's 1998 remake of The Parent Trap at the age of 11...
was connected to Prometa as one of her rehab efforts during 2007, when Star Magazine
Star (magazine)
Star is an American celebrity tabloid magazine.-History:Star was founded by Rupert Murdoch in 1974 as competition to the tabloid National Enquirer with its headquarters in New York City. In the late 1980s it moved its offices to Tarrytown, NY and in 1990 Murdoch sold the magazine to The Enquirers...
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
MTV
MTV, formerly an initialism of Music Television, is an American network based in New York City that launched on August 1, 1981. The original purpose of the channel was to play music videos guided by on-air hosts known as VJs....
series True Life
True Life
True Life is a documentary series running on MTV since 1998. Each episode follows a particular topic, such as heroin addiction as in the first episode, "Fatal Dose." The show is created by following a series of subjects by a camera crew through a certain part of their lives.-Topics covered:True...
, 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.
External links
- 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