Q: How long can I expect to wait before patients experience improvement in their condition when started on the Sinclair Method? Is there a variation in the response period?
A: As with any treatment, some patients may respond quickly to the Sinclair Method, while others may take more time to fully see the benefits. Most people will see results within 9-12 months, although some may experience immediate results, followed by a short period of increased (above goals but still below pre-treatment level) drinking.
Reasons for these differences can include: 1) length of time the patient has been drinking excessively, 2) additional medical issues, 3) co-occurring mental health issues (approx 40% of patients), 4) style of drinking (i.e. daily versus binge drinking), 5) presence of drinking “habits” as triggers (i.e. a glass of wine while cooking or after work), and 6) patient’s ‘drink of choice’ (i.e. beer versus liquor or wine).
Q: How long will I have to maintain treatment for after the patient has fully responded to their medication?
A: Because the Sinclair Method uses an opioid antagonist to block the addictive reinforcement of alcohol in the brain, drinking without the medication can cause the pathways to re-learn addiction. Therefore, a person who is using the Sinclair Method as a treatment for alcohol use disorder must always take the medication before they drink. This is for life and should be followed up at future appointments the same way you would monitor risks for other chronic conditions that require medication.
Note: if a patient’s goal is abstinence and they have achieved that goal, then there is no need for further treatment unless they decide to begin drinking again.
Q: Do I need special permission from the DEA to prescribe medicine for the Sinclair Method treatment?
A: No. Naltrexone does not have any abuse potential, therefore you do not need any special permissions to prescribe it. From SAMHSA: “Naltrexone binds and blocks opioid receptors, and is reported to reduce opioid cravings. There is no abuse and diversion potential with naltrexone.“
Q: Are there any restrictions on how many patients I can treat using the Sinclair Method?
A: No. You may treat an unlimited number of patients using the Sinclair Method.
Q: Do I need specialized training to treat patients using the Sinclair Method?
A: At this time, there are no special training requirements.
Q: Where are the direct studies on the Sinclair Method?
A: Prior to the FDA releasing a draft guidance titled Alcoholism: Developing Drugs for Treatment Guidance for the Industry in February 2015, researchers were held to the standard that medications had to produce abstinence to be considered successful. This document was critical for developing new medications or using existing medications (used for other conditions) that are focused on reducing heavy drinking or reducing overall number of drinking days.
But naltrexone isn’t new and it’s not being developed for a new condition.
Clinical trials for medications are expensive. That’s why they typically fall into two categories for research–new and novel use. Both of these research statuses often lead to exclusive patents that allow the researcher to recoup their R&D funding. Similarly, grants for medications follow the same structure.
Q: If medication is more effective when used as targeted with the Sinclair Method protocol, why was the FDA approval for daily with abstinence?
A: If you’ve ever been prescribed naltrexone in the U.S. you are aware it is labeled to be used with abstinence, even when nalmefene (Selincro), a similar drug available in Europe, is labeled for use two hours before drinking. When naltrexone was moving through clinical trials, funding was given specifically for use with abstinence-based trials. This led to abstinence-based labeling upon approval.
Millions of dollars would have to be spent to re-conduct the trials with a treatment model such as the Sinclair Method (TSM). The other two FDA-approved medications for treating alcohol use disorders are also labeled for abstinence: Antibuse because it makes you quite ill if you drink, and acamprosate, which works to reduce the withdrawal symptoms associated with giving up alcohol.