What is the Prometa® treatment protocol for alcoholism?

Experimental clinical trials are an ongoing option for individuals struggling with drug and alcohol dependency. For example, a Los Angeles-based health care services company known as Hythiam developed the Prometa Treatment Protocol, which is currently undergoing clinical trials through the National Institutes of Health. Early open-label studies of the protocol with methamphetamine-dependent individuals have yielded positive results, and double-blind, placebo-controlled studies are currently under way. Current use in alcoholics, although favorable, has been anecdotal at the time of this writing. The protocol relies on two well-established medications that have an impact on GABA: gabapentin (Neurontin) and flumazenil (Romazicon). The FDA has currently approved neither for use in alcoholism. Gabapentin is an anticonvulsant medication that the FDA approved for treating seizure disorders as well as treating neuropathic pain and may be beneficial in helping with anxiety and certain sleep disorders, as both are affected by GABA. Flumenazil is a GABA receptor antagonist and as such blocks the effects of anxiolytics such as Valium or Ativan. This is commonly used for individuals who present to the emergency room with benzodiazepine overdoses, as it reverses the effects. Gabapentin made national news over its controversial use in treating bipolar disorder before adequate trials had been conducted. It proved to be of limited value in treating this condition. That did not mean, however, that some individuals with bipolar disorder did not benefit from the drug, only that large studies failed to separate it from placebo. Although its use in treating bipolar disorder is now limited, it continues to play a role as an off-label adjunctive treatment for patients with various psychiatric illnesses, and its use in treating addiction is but one example of that.

Open-label a term used to describe the type of study where both the researcher and the volunteer/subjects know the drug or treatment that the subjects are receiving.

Double-blind study a drug study that consists of an experimental group of patients/volunteers who receive the experimental drug, medical device, or treatment and a control group who receives a placebo or the current and standard drug, medical device, or treatment.

Placebo a drug, medical device, or treatment that looks similar to the experimental drug, medical device, or treatment, but it is in fact an inactive drug, liquid, device, or treatment and will not affect the volunteer's health or illness.

Clinical trials such as the Prometa® treatment protocol are valuable resources for people who have limited means and/or who have failed previous standard treatments. Medical institutions such as universities, research foundations, pharmaceutical companies, and federal agencies often sponsor such trials. An institutional review board, which is made up of at least five members who include physicians, other health care professionals, and lay people, supervises and monitors clinical trials. Institutional review boards are established to protect the volunteer patients' health and safety as well as to protect them from unethical practices. One of the main benefits of participating in a clinical trial is the opportunity to help others while helping one's self. Additionally, having access to new experimental treatments while one's health is being meticulously monitored is invaluable. The major risk, of course, is that an adverse effect may occur putting one's own health at risk. The other major drawback is time. The enrollment process is often long and complicated, and few get accepted. After acceptance, the time and behavioral requirements can be equally arduous, but the potential payoff is great. It is important to always enter into a trial with a clear understanding of both the risks and benefits before engaging in one.

Flumazenil (Romazicon) a benzodiazepine antagonist that is used to reverse the sedative effects of benzodiazepines in the management of an overdose.

Clinical trials are valuable resources for people who have limited means and/or who have failed previous standard treatments.

Alcohol withdrawal delirium also known as DTs or delirium tremors, a syndrome that occurs after the amount of alcohol that is usually consumed has decreased, after prolonged and heavy use of alcohol, which leads to the following: changes in the individual's vital signs and adverse gastrointestinal and central nervous system symptoms in conjunction with disorintation and hallucinations.

The good news is that most individuals with alcoholism do not require medication for their withdrawal symptoms.

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