Sinclair Method



The Sinclair Method is a treatment for alcoholism that involves the use of opiate antagonists such as naltrexone or nalmefene while continuing normal drinking habits in order to decrease the craving for alcohol over time. It relies upon a mechanism called pharmacological extinction, which works by blocking the positive reinforcement effects of ethanol-triggered endorphin in the brain. Proponents claim that thousands of patients have been cured by the Sinclair Method since the early 1990s.

Treatment
Unlike alcoholism treatments/methods such as Antabuse (disulfiram), Temposil (calcium carbimide), and Alcoholics Anonymous, which all promote abstinence from alcohol, the Sinclair Method treats alcoholism by combining medication with continued drinking. Naltrexone is available in multiple forms, including tablet and injection. For tablet form, a patient following the Sinclair Method takes a 50 mg tablet one hour before every drinking session. Patients who achieve success with the treatment experience a reduced urge to drink over time.

The treatment developed based on this theory is called pharmacological extinction. It involves the use of competitive antagonists to endorphins being taken before alcohol consumption in order to block the endorphins from being used by the drinker's system. When the patient drinks without the endorphin reinforcement, it causes extinction. Use of this effect has been standardized into a technique called the "Sinclair Method", named after the man who first developed it, Dr. John David Sinclair.

As of April 2010, the most comprehensive reference on the Sinclair Method written for the patient is The Cure for Alcoholism by Dr. Roy Eskapa, published in 2009. Until more sources become available, much of the information on the Sinclair Method comes from this source.

The Sinclair Method has two steps: ingestion of an endorphin blocker, followed by drinking. Naltrexone is the most commonly used endorphins blocker because naltrexone is readily available and approved by the FDA for treatment of alcoholism. Other medications such as naloxone and nalmefene may be used in the future, but are not as readily available. The Sinclair Method prescribes drinking "as you normally would" while taking naltrexone.

The effects of the Sinclair Method can take from two weeks to several months before they become noticeable. This period increases if the patient abstains from drinking, or largely drinks in an environment other than that in which they acquired their addiction. Taking naltrexone without drinking will result in a small decrease in craving while the naltrexone is being taken, but will not result in extinction.

The goal of the Sinclair Method is to return a person's desire for alcohol to their rational control over a period of three to fifteen months. They may continue to drink because they perceive rational benefit to drinking, but will no longer be driven to drink by uncontrollable urges. Once the patient is no longer drinking on a daily basis, administration of naltrexone is reduced to just those days during which drinking is expected, an hour before the drinking occurs. Taking naltrexone before drinking will need to be done for the rest of the patient's life, otherwise the endorphin conditioning will re-establish itself.

Theory
The basis of the Sinclair Method is that taking naltrexone changes some addicting behaviors into unaddicting behaviors. Your typical alcoholic increases their desire for alcohol when they drink. When an opiate antagonist like naltrexone is administered, drinking decreases the desire for alcohol because of naltrexone's interference with the brain's reward system.

Endorphins are part of the body's reward system for performing healthy behaviors. Sex, exercise, eating, and risk taking generally result in the release of endorphins. The endorphins "teach" the body that the behaviors that were performed prior to the endorphin release are behaviors that should be repeated. Alcohol triggers the release of endorphins into the system, reinforcing drinking behavior. Continued consumption of alcohol strengthens this reaction. The theory suggests that for those with a strong endorphin reaction (generally due to genetic factors), the pro-alcohol conditioning exaggerates the strength of arguments for drinking, and perpetually keeps drinking in the person's mind as a favorable option.

Operant conditioning suggests that, should you perform a behavior and be rewarded, then the urge to perform that behavior becomes stronger. Furthermore, if you perform a behavior and are not rewarded, then the urge to perform that behavior gets weaker. This effect is referred to as the extinction of that behavior. This was demonstrated in the research by Edward L. Thorndike and later, B. F. Skinner.

In the case of alcoholism, the behavior is the consumption of alcohol, and the reward occurs when the neurons involved with the drinking behavior receive a flush of endorphins. By this theory, if the drinking behavior occurs and the neurons do not receive their flush of endorphins, then the pro-alcohol conditioning should be extinguished. In practical terms, if you drink and the endorphins are blocked from stimulating the neurons, then you lose interest in drinking. By this means, the urge to drink that is the cause of alcoholism is eliminated and the alcoholic regains control of their drinking.

Evidence of efficacy
Evidence for this treatment was originally published in 2001 in a study entitled "Targeted Use of Naltrexone Without Prior Detoxification in the Treatment of Alcohol Dependence: A Factorial Double-Blind, Placebo-Controlled Trial". In this study, patients were divided into four groups. The first received naltrexone and given counseling to encourage moderate drinking. The second received placebo and given counseling to encourage moderate drinking. The third received naltrexone and given counseling to support abstinence. The fourth received placebo and given counseling to support abstinence.

Although all groups in the study experienced a decrease in drinking, the group which received naltrexone in combination with moderate drinking were far less likely to relapse into heavy drinking than the other three groups. In the 32 week run of the study, 27% of those who combined drinking with naltrexone had never had a relapse to heavy drinking, compared to 3% for those who combined abstinence with naltrexone.

Roughly a quarter of the participants of the study went completely abstinent and stayed that way. Overall, four-fifths of the participants reduced their drinking to at or below healthy drinking levels. In three- and five-year follow up studies, roughly half of those who benefited from the program continued to take a dose of naltrexone before drinking. For all those who continued the program, there was zero incidence of relapse.

The Sinclair Method is used extensively as an outpatient treatment at The Contral Clinic in Finland. To date, they have treated tens of thousands of patients with a success rate around 78%, with 25% reducing their drinking to complete abstinence with little or no craving. The effect of opiate antagonists on addictive behaviors has also been demonstrated for gambling and kleptomania.

History
In the 1970s, Finland's National Public Health Institute developed a breed of Wistar rats called the AA line which exhibited many behaviours related to human alcoholism. The research facility determined that this tendency was caused by an increased reactivity of their endorphin system to the consumption of alcohol. Both human and rat biology reacts to the presence of alcohol by releasing endorphins, and these rats produced more endorphins in that event than a typical rat.

Beverly Rayfield is widely credited with bringing the Sinclair Method into the United States. She further developed the protocols Dr Sinclair developed and used this protocol for dually diagnosed patients. She name the program the Sinclair Method in honor of its discoverer, John David Sinclair.

A United States patent for the "Method for Treating Alcohol Drinking Responses" was issued on November 21, 1989. David Sinclair was listed as the inventor, and the patent was assigned to Alko Limited (Helsinki, FI). The patent expired on June 13, 2008, and Sinclair has stated that the existence of the patent "may have delayed the process" of spreading awareness of the Sinclair Method.

Obstacles
Naltrexone was approved by the FDA in 1984. In 1994, the FDA approved use of naltrexone in conjunction with drinking to extinguish alcohol dependence. Since then, its adoption has been slow and spotty. A possible cause for this is that it goes against the principles of most treatment organizations, which advocate abstinence and/or faith-based alcoholism recovery, in conjunction with abstinence. A related obstacle is that the treatment is fairly new, when most treatments already have well established support groups and are widely known.

Project Combine, the largest controlled clinical trial in the alcoholism treatment field, published in the Journal of the American Medical Association in May, 2006, has shown "that while naltrexone was effective in its own right, combining it with the specialized counseling added no more effectiveness than naltrexone by itself" according to Dr. Raymond Anton, the coordinator for the trial. Naltrexone had been approved by the FDA for use within a comprehensive program of alcoholism treatment. The new results should lift this requirement, allowing doctors to prescribe naltrexone with only medical supervision but without intensive therapy. This confirms findings from earlier smaller trials with naltrexone in Australia and with nalmefene in Finland.