Article & Discussion - Prometa: Unproven meth, cocaine ‘remedy’ hits market

Discussion in 'General Addiction discussion' started by tre2005be, Jul 10, 2006.

  1. tre2005be

    tre2005be Silver Member

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    May 31, 2006
    By Anne Harding
    NEW YORK (Reuters Health) - A new treatment that can be given on an outpatient basis resulted in a statistically significant reduction in methamphetamine use by addicted individuals, according to the first clinical study of the protocol.
    Of the 50 patients who entered the study, 36 men and women completed the study. The subjects reported using meth on 80% of the 90 days prior to treatment, but they used the drug on just 28% of the 84 days following the first day of treatment, representing a 65% reduction in drug use.
    "I think we've found the first clinically effective treatment for methamphetamine addiction," the study's lead author, Dr. Harold C. Urschel III, told Reuters Health. Urschel, an addiction psychiatrist, works for Research Across America, a Dallas-based company that performs independent clinical research, reported the findings last week at the annual meeting of the College on Problems of Drug Dependence in Scottsdale, Arizona.
    Previously, he noted, if he had got a 25% to 30% reduction in drug use among meth addicts with treatment, "I'd be just jumping for joy. Urine tests showed that the study participants were telling the truth about their use or abstinence about 85% of the time.
    PROMETA consists of a series of intravenous and oral treatments given in a doctor's office over the course of 30 days. Developed by the for-profit company Hythiam, Inc., it consists of FDA-approved drugs used "off-label," meaning the FDA has not approved their use for this condition.
    PROMETA consists of an anti-anxiety drug from the class known as benzodiazepine antagonists, and a drug that modulates one of the brain's main signaling systems, GABA. Also included are nutritional supplements.
    Among the 31 people who completed a series of questionnaires measuring their drug craving, 30 reported a reduction in craving, while one reported no change.
    Meth addicts often drop out of treatment in the first few days, Urschel noted, largely because the drug has damaged their brain so concentration is extremely difficult. But in the current study, he said, "the patients' memory and concentration almost uniformly across the board came back," as soon as the first day of treatment. "That alone allows the people to focus on sitting in intensive outpatient treat and learn the skills necessary to staying sober."
    While the mechanism for the protocol's effectiveness is not clear, Urschel said the main hypothesis is that it somehow restores the function of the GABA system, which has been damaged by drug or alcohol use. In healthy people, he noted, the neurotransmitter helps people to stay calm and relaxed. Treatment may restore its function, reducing anxiety.
    The current study did not include any psychosocial interventions, which are usually part of the PROMETA protocol. Urschel said that the results would probably be better if the drug compound was given with these interventions.
  2. Cure20

    Cure20 Gold Member

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    May 1, 2005
    36 y/o from Canada
    Wow a 65% reduction rate in the first day of treatment is very impressive.
  3. ~lostgurl~

    ~lostgurl~ Platinum Member & Advisor Donating Member

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    Dec 23, 2004
    from Australia
    I found Effexor significantly reduced meth cravings, I wonder if this is somehow similar to how Prometa works?
  4. Universal Expat

    Universal Expat Gold Member

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    Nov 15, 2005
    39 y/o from kazakhstan
    Prometa: Unproven meth, cocaine ‘remedy’ hits market

    A drug cocktail that backers say is the first effective treatment for methamphetamine and cocaine addiction is dividing substance abuse experts into two hostile camps — those who say they have seen it work miracles and those who say it has been rushed to market without any scientific testing.

    The strident debate over the "Prometa protocol," manufactured by the Hythiam Corp., is complicated by the checkered Wall Street career of the company's CEO, Terren Peizer, who previously championed an anti-AIDS drug that has yet to make it to market.

    Hythiam, which is based in Los Angeles, launched Prometa in 2003 in private clinics, where meth and cocaine addicts, as well as alcohol abusers, pay $12,000 to $15,000 for a one-month outpatient treatment.

    Now the company is aggressively pushing Prometa for the mass market, and asking governments and insurers to foot the bill. Already, four county and municipal programs have launched pilot programs and are offering powerful testimonials for the treatment.

    The company has a huge receptive potential customer base in health and law enforcement officials in countless small communities that have been broadsided by the costly and seemingly intractable meth and "crack" cocaine epidemics. And it has big ambitions in this grim landscape.

    “We believe strongly that one day Prometa will be a standard of care, and should be available to everyone,” Peizer said.

    But critics note that the field of addiction treatment is littered with "miracle cures" that ultimately failed or, in a few cases, caused harm to test subjects. And they warn that Prometa has never been subjected to double-blind, placebo-controlled testing — the gold standard for determining whether therapies are safe and effective.

    ‘It preys on ... desperate patients’
    “The marketing is way ahead of the science,” said Lori Karan, a physician-researcher at the Drug Dependence Research Laboratory at the University of California San Francisco. “It preys on the needs of desperate patients, sets unreasonable hopes and expectations and takes advantage of scarce economic resources.”

    "What’s being touted here is what people have always wanted for addiction ... something dramatic that is going to fix their brain," agreed Peter Banys, director of substance abuse programs at the VA Medical Center in San Francisco. "I would never recommend that someone spend $15,000 on this with the current state of data (and) I think it’s improper to spend public money on this product at this time."

    Prometa has made its way to consumers quickly because of an exception in FDA regulations that allows physicians to prescribe drugs “off-label” — that is, for purposes other than the one for which they were originally approved. For example, Botox, best known as a wrinkle eraser, originally was approved as a treatment for an eye muscle problem but is used off-label to treat migraine headaches.

    However, Hythiam is exploring new territory by grouping three FDA-approved drugs for off-label purposes in Prometa. The company doesn't own or produce the three drugs — flumazanil, gabapentin and hydroxyzine — but claims ownership of the process by which they are delivered into a patient's system along with nutritional supplements. It licenses the protocol to individual doctors and clinics, grants franchise rights and administers the treatment at its Prometa centers.

    The company, which is seeking a U.S. patent on its “proprietary dosing algorithm,” is secretive about the specific details of the treatment. But it broadly describes it as a process in which patients receive about one hour of intravenous infusion for three straight days, followed by about a month of oral medications and nutritional supplements. Near the end of the month the patient returns for two more IV infusions. The formulation varies, depending on whether it is being used to treat meth, cocaine or alcohol dependency.

    Hythiam's doctors aren't sure how Prometa works, but they hypothesize that it repairs the damage to neurotransmitters in the gamma-aminobutyric acid (GABA) receptor complex — the part of the brain that inhibits or calms — caused by extended drug and alcohol abuse.

    The effect, they believe, is to halt cravings for the drug and allow addicts to think clearly enough to concentrate on changing their lifestyles.

    “It resets the receptors and they stay reset,” Matthew Torrington, medical director of the flagship Prometa Center in Los Angeles, told a group of Washington state and local legislators at a recent presentation. By quelling the cravings, he said, "It intensifies the prowess of psychosocial treatment."

    Try it now, prove it later
    Hythiam is now conducting double-blind studies at UCLA and the University of South Carolina in an effort to establish the efficacy of Prometa and rule out the “placebo effect,” where patients who believe they are receiving a treatment for a medical condition show improvement even when they are given an inert substance.

    But those results may not be final until 2008, and the company argues that the results of its field trials are so compelling that use of Prometa should not wait.

    “Counties don’t care about double-blind placebo-controlled data," said Peizer. “What’s interesting about Prometa is that out in the field — in the counties, justice systems, private centers — the clinical relevance is being shown daily."

    Already, according to Hythiam, more than 1,000 people have undergone treatment with Prometa, with providers reporting unheard of abstinence rates of between 60 percent and 80 percent. Thousands more will receive the treatment in the next year in private settings alone, it says.

    The company also is making inroads in the government sector.

    Fulton County, Ga., which has a cocaine epidemic and an emerging meth problem, announced in October that it was launching a Prometa pilot program for its parole and probation programs in an effort to curb high recidivism rates.


    This is unreal, they dont know how it works or even if it is safe. They dont even know what the long term effects on humans will be. But they have rushed this to the market. Well, more victims in this insane illogical war on drugs.
  5. Paracelsus

    Paracelsus Platinum Member & Advisor

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    Aug 31, 2006
    from U.S.A.
    Re: Unproven meth, cocaine ‘remedy’ hits market

    If the producers aren't sure how it works, it might be dangerous to make it a standard in drug addiction treatment, but it doesn't mean 100% it's a dangerous product. Piracetam and LSD are compounds whose action on the brain isn't fully known yet, but they both have been proven to be quite safe and non-toxic.

    Study on Prometa (don't know how impartial it is):

    It is weird why they don't have any formula for Prometa. I mean what it contains. Not on the Hythiam Official Website and not on the Prometa Website. Dubious.
  6. BobTheGreat

    BobTheGreat Silver Member

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    Jan 25, 2007
    Re: Unproven meth, cocaine ‘remedy’ hits market

    On 60 minutes they showed the drugs: Flumazenil, gabapentin, and Hydroxyzine hydrochloride respectively.

    Full article:

    Cliff notes: guy rushed it to market because he want to make millions and do it fast.

    The drug works instantly and while on it. After 14 months the drug was pulled by the county that approved it in court because it only cured 57% of patients. It was pushed by people with stock in it. But got dropped for funding because it wasnt better than treatments already used.

    A double blind study was done and waiting publishing. It was done by a pychiatrist that uses prometa as a treatment at his clinic.

    Guy was emotional when talking about helping patients. He probably has gotten good at acting... He seemed like a snake in the grass from the report and all other doctors said it needed the gold standard(double blind study) for FDA approval before used. IMO it needs to be done by someone not finacially linked to the drug. No need for possibly motivated test admins.

    Also it doesnt mean anything until a year and no drug Im aware of cant keep people off forever. It is a change in life style and burning the bridges to your unwanted past to get over the drugs that haunt the human race and monkeys and mice for that mater(btw I dont oppose it. survival of the fittist.... Not that taking a life should be an easy decision ever.) :eek:fftopic:

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