FORT MYERS, Fla. (02/22/19) -- A nonprofit founded by an actress is raising awareness of a "cure for alcoholism," a medical treatment for alcohol use disorder (AUD) that involves taking an FDA-approved opiate-blocking pill one hour before drinking.

"Drink yourself sober," is how the C Three Foundation describes the Sinclair Method (TSM) because a majority of people suffering with AUD who stick to this simple treatment end up reducing their alcohol consumption to within low risk levels over the long term, while about one quarter become totally abstinent. In other words, addicted drinkers can become "normal drinkers" again.

This approach might seem counter-intuitive, especially to those around the world who recently finished "Dry January," a campaign that encourages drinkers to abstain from alcohol for one month, but the science of TSM is sound.

"If taking a month off from drinking makes you feel better or leads to a lifetime of healthy choices, that's great. However, some problem drinkers are at risk of overdoing it when they start back up," said Claudia Christian, founder of C Three Foundation, of the global Dry January campaign. "When I was struggling to control my own alcohol misuse, I would go 'cold turkey' for a month, three months, six months...before 'falling off the wagon' worse than before because of what’s called the 'alcohol deprivation effect.' Once the honeymoon period of sobriety wore off, the constant physical and mental cravings for alcohol always came back."

Best known for her role as Commander Susan Ivanova on the science fiction television series "Babylon 5," Christian says the Sinclair Method saved her life in 2009 after about a decade of struggling with alcohol use disorder.  She has been working to promote the treatment ever since, through her nonprofit C Three Foundation, her 2014 documentary film about TSM titled "One Little Pill,” and her memoir “Babylon Confidential.”

"We tend to avoid the words 'alcoholic' and 'alcoholism' because of the narrowness of those terms. AUD describes a broad spectrum of alcohol misuse from occasional binge drinking to chronic daily dependence on alcohol. Plus there is so much stigma associated with those terms as well," Christian said. "'Alcohol use disorder' is a more accurate way of describing what's happening to those who are suffering from alcohol addiction. AUD is progressive over time and there is medical help to catch it early and even prevent it."

HOW THE SINCLAIR METHOD WORKS

The Process of "Pharmacological Extinction"

The Sinclair Method is named after the late Dr. John David Sinclair, an American who began developing the treatment in the 1970s while studying with alcohol addicted rats in Finland. Sinclair discovered that the opiate-blocking drug naltrexone can disrupt the body's behavior/reward cycle, eventually "rewiring" the brain and restoring it to what is essentially a "pre-addicted" state. But the method only works if the patient continues to consume alcohol while taking the drug.

When naltrexone is ingested one hour prior to drinking, it blocks the brain's naturally occurring opiates -- called endorphins -- from being released when alcohol is consumed. When endorphins are blocked, the drinker does not get the involuntary "rewards" that drive a person with AUD to drink excessively. Over time, the brain stops associating alcohol with those rewards, resulting in reduced cravings and improved control over alcohol use. The process is called "pharmacological extinction."

"Usually when a person with alcohol use disorder drinks, they get a huge endorphin reward from alcohol, and that's what makes them want more and more and more," Christian said. "After a few months of taking naltrexone and waiting an hour before taking a drink, I got to the point where I'd have a few sips and then say, 'Meh, I’m done.' I felt no compulsion, no 'I want more, more, more,' cravings that had affected me in the past."

Christian responded to naltrexone quickly, so it only took a few months of practicing TSM for her to reach the point of "pharmacological extinction" where previous triggers to drink had no influence on her. Most people take 6 to 12 months to reach extinction, and only if they adhere to the method strictly. Almost 25 percent of people see absolutely no reduction in the first 30 days and half only see a small reduction.

The average person struggles for about a decade before seeking help for AUD. Those who use TSM early to prevent escalating risks from alcohol can often see improvement much faster.

HOW PAVLOV'S DOG HELPED CURE ALCOHOL ADDICTION

In psychology, the term "extinction" was first used by Russian physiologist Ivan Pavlov while researching classical conditioning using dogs.

Most people know of the experiment in which Dr. Pavlov rang a bell each time he gave his dog food. Pavlov's dog learned to salivate because the sound of the bell meant food. This was a conditioned, involuntary response brought on by repeated sessions of pairing a ringing bell with food. At first, the food was the reward. Over time, the dog salivated at the sound of the bell alone -- even without the presence of food. The sound of the bell became a trigger for a desire that needed to be fulfilled, and the dog was powerless to stop its reaction.

But then after the doctor kept ringing the bell without delivering food, the dog eventually stopped its conditioned response of salivating at the sound and returned to its pre-conditioned state. Pavlov called this process "extinction."

Similar to the conditioned response in Pavlov's dogs, Dr. Sinclair would later observe that alcoholics have an involuntary conditioned response to alcohol that can also be weakened through extinction using naltrexone. Through TSM, patients use a medication to unlearn a previously conditioned response. The combination of medication and alcohol teaches the brain not to abnormally crave and anticipate alcohol.

"To be clear: naltrexone does not prevent you from becoming drunk, and you may still get a pleasurable 'buzz' while drinking," Christian said. "The reward that TSM targets in people with alcohol addiction is more subtle, yet more powerful than an intoxicating buzz."

For a non-addicted drinker, the connection between alcohol and the endorphin rewards is weaker than for someone with AUD. Situations and stimuli do not cause the same type of involuntary response of triggering intense cravings as in someone with AUD. That is why a "normal" drinker is better able to self-regulate consumption than those with AUD.

NALTREXONE: THE LITTLE KNOWN DRUG THAT CURBS ADDICTION

Peer Reviewed Trials Show Method Has 80 Percent Success Rate

Naltrexone is safe and non-addictive. There have been more than 120 peer-reviewed clinical trials using naltrexone to treat AUD. Though TSM has been found to have a 78 percent success rate, the method is still relatively unknown to both the general public as well as the medical community in the United States.

Many treatment professionals who do prescribe naltrexone for AUD often instruct their patients to abstain from alcohol while taking the drug, which is not effective in weakening their conditioned reward response to alcohol.

Dr. Roy Eskapa, based in South Africa, was a colleague of Dr. Sinclair and is the author of "The Cure for Alcoholism," the definitive book on TSM. While it is the first method of treatment prescribed for AUD in Finland, he said TSM is practically unknown in the United States.

"Doctors and other health practitioners simply do not or cannot keep up with the literature; thousands of scientific and medical articles are published annually and they simply do not know that medications known as 'opioid antagonists' can achieve around 80 percent success rates if used correctly. Naltrexone has to be used along with the behavior -- drinking -- to work most effectively," Eskapa said. "It can work for the hard core, and it can also work for those social drinkers who drink too much -- people who go out for a few drinks and find they are beginning to lose control."

Eskapa said people with severe AUD can gradually detox on TSM without the use of addicting benzodiazepines, such as Librium or Valium, and without the risk of brain damage occasionally associated with rapid withdrawal.

In the United States, naltrexone is a generic medication (also sold under the brand name ReVia) that can be purchased for as little as $1-2 per pill. A prescription is required for naltrexone in the United States.

In 1994 the FDA approved naltrexone to treat AUD but the instructions provided with prescription bottles direct people to take one 50 mg pill per day and to maintain abstinence, which is not nearly as effective in reducing alcohol cravings as following TSM.

Jenny Williamson, executive director of the C Three Foundation, said the U.S. Food and Drug Administration (FDA) approved naltrexone in an era that held abstinence as the only measure of success for alcohol addiction. If the drug were up for approval in the U.S. today, she believes it would be labeled per TSM guidelines similar to the way nalmefene is labeled in Europe.

"When a doctor or pharmacist unfamiliar with naltrexone or TSM looks the medication up, they don't see instructions for the Sinclair Method," Williamson said. "Right now, no one but C Three Foundation is out there educating these medical professionals. This is one of our biggest challenges to gaining mainstream adoption of TSM."

COMPREHENSIVE LISTING OF VERIFIED SINCLAIR METHOD PROFESSIONALS

One of C Three Foundation's major initiatives is publishing the world's most comprehensive online listing of verified TSM providers, including telemedicine providers.

The listings can be found online at: https://cthreefoundation.org/find-a-physician

The foundation aims to list 300 verified TSM providers globally this year and encourages professionals to submit their information to be listed.

Another online resource the organization provides is a discussion forum where veteran TSM patients can lend advice and encouragement to those new to the method. The online forum is located at: http://optionssavelives.freeforums.net

"Although many people benefit from additional counseling, one of the many benefits of the Sinclair Method is you can do TSM in the privacy of your own home with a prescription from your family physician or an online provider for a fraction of the cost of an inpatient detox or rehab facility," Williamson said. "There's still a terrible stigma about alcoholism, and you can do TSM without having to miss any work for rehab or telling anyone you know."

Williamson said C Three Foundation hopes to convince the FDA to change the instruction labels for naltrexone to comply with TSM. In the future, the organization will be pushing for naltrexone to be sold over-the-counter without prescription as it is in some European countries.

Dr. Eskapa notes that after Dr. Raymond Anton and others published the results of the largest multi-center trial on addiction, The Journal of American Medical Associations stated that naltrexone should be made widely available in general medical settings and not just in specialist settings.

"It was ignored," Eskapa said of the general response from addiction specialists to the landmark study. "Large oil tankers turn around slowly."

INTERVIEW LOCAL TSM PROVIDERS & PATIENTS

Sources Available Upon Request

C Three Foundation has a list of TSM providers and patients across the U.S. who are willing to give interviews to the press. Contact us to request a local source in your geographic region.