Prometa shows promise as new addiction treatment

Terrence Nolan still remembers the first time he got drunk. "I was 12 years old, in junior high school, and some older friends of mine got hold of some hard liquor," Nolan recalled. "We drank and got drunk. We drank until we threw up and then we drank some more. I vividly remember walking home down 16th Street in Hermosa Beach (Calif.) in the middle of the night singing 'Wake the Town and Tell the People.'"
Now, 47 years later, because of Nolan's alcoholism, his wife has divorced him and his kids ignore him. He has been charged on several occasions with driving under the influence and has been hospitalized numerous times with alcohol-related seizures, shakes and tremors.

He's also been through various recovery programs, managing to go from daily drinker to periodic binger. His latest period of sobriety lasted two years, but he relapsed in October.

"I went on a horrendous binge," the Torrance, Calif., resident said. "I quit going to work, left my apartment and checked into a motel, alone. I had plenty of money, and I was drinking nonstop literally around the clock. I drank such quantities that I would pass out, and then I'd come to and drink some more. At times, I'd stay just sober enough so that I could walk back to the liquor store and get more. I was there about a week when something inside of me said, 'You have to go somewhere, do something.' So I went to work."

Nolan works for an exotic plant grower. Upon finding his AWOL employee drunk and holed up in an outbuilding on the property, Nolan's boss took him to the Little Company of Mary Peninsula Recovery Center in nearby San Pedro, because he'd heard they were offering innovative medical treatment for addiction. He was right.

For the past two years, Dr. Crescenzo Pisano, director of the Peninsula Recovery Center, has been working with a new drug-based treatment option for people addicted to alcohol, cocaine and methamphetamine.

It's called Prometa, and it uses prescription medications and nutritional supplements to combat physiological cravings in an effort to reduce or eliminate instances of relapse.

Pisano, a San Pedro native who has spent the last 22 years working in the field of substance-abuse recovery, was the first doctor in the United States to use the new treatment, which was developed in Spain. The treatment is now offered in more than two dozen medical facilities across the country. So far, Pisano has treated 100 patients with Prometa and is encouraged by the early results.

"This treatment addresses why people relapse, and I think it's better than anything else we have," Pisano said. "People can still relapse, but I think (Prometa) improves their chances for recovery by at least twice what the usual treatments do. It will allow the process of recovery to go forward rather than (the patient) continuing to take one step forward, two steps back."

Nolan, after more than two weeks of detoxification, got the treatment in November.

"I have a lot of experience sobering up," he said. "And while three months of sobriety, to me, doesn't constitute evidence one way or the other, I will say the treatment helped me. If I hadn't had Prometa, I wouldn't have felt well enough to go back to work for at least a month. I found it startling that I took the last treatment on Tuesday, and I was able to go back to work Wednesday morning."

Prometa also helped Rebecca Tassinari, 39, or Cameron Park, Calif., who has been addicted to methamphetamine for 10 years. During that time, she had one prolonged period of abstinence.

"I once stayed clean for a year and a half through Narcotics Anonymous and just hanging on," she said. "I was going to meetings three times a day, but I still craved constantly, every day."

Tassinari's experience is consistent with the high relapse rate found by a 2001 Brandeis University study that showed 69 to 77 percent of people treated for cocaine or alcohol abuse suffer a relapse within one to two years.

But since undergoing the Prometa treatment in August, Tassinari said she has been totally freed from cravings. "(Prometa) buys you a lot of time to work on recovery, because it takes away the physical cravings completely," Tassinari said. "I would recommend it 100 percent - 1,000 percent."

The treatment procedure takes place in a medical facility where patients receive prescription medications intravenously. The entire infusion procedure lasts about 1 1/2 hours and is repeated over two or three consecutive days. It can be completed on an inpatient or outpatient basis.

In the three weeks that follow this first phase, patients continue the treatment at home, taking prescription medications and nutritional supplements orally. In the case of cocaine and methamphetamine addiction, a second round of one or two infusion sessions are given at the end of the monthlong treatment. The treatment is quick, easy and virtually painless, but it isn't a miracle cure.

"Prometa is a breakthrough pharmacological treatment that helps with physical cravings," said Abel Castanon, the site manager for Hythiam, the Santa Monica, Calif.-based company that licenses Prometa's use in the United States. "It is not a cure for addiction. It is a missing link in recovery treatment that helps people concentrate and be more successful in their aftercare. But they must do the aftercare."

Aftercare typically consists of behavioral therapy, psychological counseling, 12-step programs and other therapies, many of which are determined case by case. But Prometa targets the early stages of the recovery process, when relapse is a common stumbling block to prolonged recovery.

"The brain is in balance between stimulatory chemicals that keep you going and relaxant chemicals that slow you down," Pisano explained to a full room at a recent community lecture at Peninsula Recovery Center. "With prolonged drug and alcohol abuse, the brain is depleted of relaxant chemicals, or GABA (gamma aminobutyric acid), which is critical to maintaining an even keel in terms of brain function. "GABA is to the brain what brakes are to a moving vehicle," he said. "If you can't put the brakes on, you're going to have real trouble. That's where the cravings come in. This treatment focuses on restoring GABA and eliminating the toxic byproducts that build up and make GABA not function."

With GABA functioning again, Pisano explained, the brain is recharged and patients are less apt to experience cravings. They can think more clearly, stay focused on their recovery, have a better chance of avoiding relapse and allow the brain time to recover from long-term damage.

"Most people think drug abuse is a matter of willpower, and it affects people who are weak-willed. But people who are working in the field realize it's something more significant," said Pisano. "Addiction is a brain disease, and prolonged use of drugs and alcohol changes brain function in fundamental ways. Brain imaging studies show it takes minimally two to three years for the brain to get back to normal function."

Pisano added that Prometa's restorative approach is the opposite of the traditional approach to substance-abuse treatment. "For years, treatment has typically included flooding the brain with benzodiazepine," he said. "These are drugs that help with symptoms of withdrawal, anxiety, tremors and seizures, but they do nothing to reverse the underlying process of restoring GABA. They just slow your body's ability to make it."

Exactly which drugs the Prometa treatment protocol employs is a mystery to patients and will remain so. Hythiam won't divulge any information about which medications are used in the treatment, claiming the details are proprietary, but they maintain that all the drugs used in the Prometa treatment protocol have been approved by the FDA for uses other than combatting dependency.

Controlled clinical trials are now under way at Cedars-Sinai, University of California Los Angeles and Southern University in Louisiana, and if they prove effective, Prometa could become a regular weapon in the battle against addiction.

Health insurance policies do not cover the experimental treatment. Whether they will in the future depends on the results of the clinical trials, but in the meantime, the treatment is available to individuals willing to pay for it out of pocket. Costs range from around $10,000 to $17,000.

"The treatment is a big investment," said Tassinari. "But when you think of it in terms of saving your life, it's really not that much. I took out a personal loan to pay for it, and I'd do it again. I'd borrow twice as much. Plus, the expense is an additional layer of commitment that keeps you serious about recovery."

If the price tag for this particular treatment is big, the scope of the disease and the economic toll it takes on society are enormous.

According to the Substance Abuse and Mental Health Services Administration, the federal agency that oversees the quality and availability of substance-abuse treatment, one out of four people in the United States is affected by chemical dependency, and more than 9 percent of the population older than 12 is classified as suffering from substance abuse or dependence.

According to a 1998 study by Harwood, et al, the total economic cost of alcohol abuse was estimated to be $184.6 billion, and the total cost of drug abuse was estimated at $143.4 billion, figuring in, among other things, the medical consequences of alcohol and drug abuse, lost earnings linked to premature death, lost productivity, motor vehicle crashes, crime and other social problems. The public pays 76 percent of those costs through a variety of federal, state and local governmental programs, with insurance picking up the remaining 24 percent.

Whether Prometa will prove to be as promising in the fight against addiction as the initial case studies indicate remains to be seen. Until then, officials won't be convinced, and Prometa will remain experimental.

"Treatment case series are interesting," said Frank Vocci, director of pharmacotherapies and medical consequences of drug abuse at the National Institute on Drug Abuse. "But they have to be backed up with scientific studies. Medical history will show you that there have been many cases where a particular therapy that showed great promise early on didn't show effectiveness in formal studies. But technology lets us look at the brain on all kinds of different levels, and we're studying medications that will have great therapeutic value in managing the disorder."

Pisano said Prometa may well be counted among those promising treatments. "From what I've seen (with Prometa), one out of two people won't make it (through recovery)," he said. "But those are much better odds than 9 out of 10."

However the Prometa numbers bear out in the long run, those in the know say there is no shortcut or replacement for the hard, painful work of recovery.

"This doesn't replace the other stuff you have to do in recovery," said Nolan. "And if you think it does, you're in denial. The most difficult part of addiction is that it'll sneak up on you. Awareness and support are the only real solutions."

To learn more about Prometa, go to prometainfo.com or hythiam.com.