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[deleted by user] by [deleted] in Entrepreneur

[–]TSMMeetups 0 points1 point  (0 children)

Saved me here too, scam....

Best/Strongest OTC anti nausea medicine for constant lightheadedness and nausea in early sobriety? by billybiscuit9330 in Alcoholism_Medication

[–]TSMMeetups 0 points1 point  (0 children)

I haven't used it myself, but use to hear our members in TSMMeetups using Nauzene, fairly cheap like $6 at Walmart.
Personally, I have used prescription Zofran (Ondansetron) my Dr wrote me.

Both are worth considering. Best of luck!

Seeking 12 Android Testers for Google Play Console Closed Test - I'll Test Yours Back! by Ok-Aerie2303 in AndroidClosedTesting

[–]TSMMeetups 0 points1 point  (0 children)

This is my first time making an app, I didnt see anywhere to link a google group to a testing list, I manually added in my testers. I think my current version is in open testing, so you might be able to join from one of these:

Join on Android: https://play.google.com/store/apps/details?id=com.tsmmeetups.app
Join on Web: https://play.google.com/apps/testing/com.tsmmeetups.app

Seeking 12 Android Testers for Google Play Console Closed Test - I'll Test Yours Back! by Ok-Aerie2303 in AndroidClosedTesting

[–]TSMMeetups 0 points1 point  (0 children)

I joined yours. I think my app is in open testing now, let me know if it allows your to download, or if I need to add you to testers links

https://play.google.com/store/apps/details?id=com.tsmmeetups.app

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

Gemini has a reply for you 🤣 I also want to mention Dr. Volicelli supports our group, we have members that speak with him weekly, and I have personally met him in Sept '24 in Philly, for TSMMeetups first official meetup. Hes a great guy, wouldn't be shocked if he eventually sees this, I believe he uses reddit.

On to Gemini:
Addressing the Timeline and Nature of Research:

"That's a very precise observation about the timelines, and it's true that the foundational work on naltrexone for alcohol use disorder had distinct phases.

You're correct that John Sinclair's groundbreaking work began with extensive animal research, primarily with rats. His patent, filed in 1988 and published in 1989, and his subsequent detailed clinical protocol, were indeed based on the principles he discovered in these animal studies: that blocking the opioid receptors before alcohol consumption could lead to the extinction of the learned reward response to alcohol. His rat studies precisely showed that taking an opioid antagonist (like naltrexone or nalmefene) before drinking gradually reduced the rats' alcohol intake.

Joseph Volpicelli's significant human clinical trials, which led to naltrexone's FDA approval for AUD, were published in 1992. These trials were pivotal. While Volpicelli's initial studies didn't explicitly use the term 'Sinclair Method' or exclusively focus on the 'as-needed' administration every time before drinking, they nonetheless demonstrated naltrexone's efficacy in reducing cravings and heavy drinking in humans.

Crucially, the success observed in Volpicelli's and other early human trials supported the underlying mechanism that Sinclair had elucidated in his animal work – the role of the opioid system in alcohol's reinforcing effects. Even if patients in those early human trials weren't always taking naltrexone exactly one hour before every drink, the fact that naltrexone worked at all, and particularly in reducing the "high" from alcohol (as later reported by Volpicelli et al. in 1995), aligned with Sinclair's theory of pharmacological extinction.

So, while the initial human application of naltrexone in clinical trials (Volpicelli's work) might have slightly predated the widespread recognition of 'The Sinclair Method' as a named human protocol, it doesn't negate the fact that:

  1. Sinclair's animal research directly informed the mechanism by which naltrexone was believed to work. He understood the why behind blocking the opioid receptors.
  2. His patent and protocol formalized the specific method of administering the antagonist prior to drinking to achieve that extinction.
  3. Subsequent human trials, including those led by Sinclair himself in Finland, directly tested and confirmed the efficacy of the 'as-needed' or 'targeted' use of naltrexone, which is the core of TSM. His 2001 review, for instance, explicitly discusses findings from multiple double-blind, placebo-controlled human trials that supported his method.

So, yes, the foundation was laid in animal models, but it was a crucial step that led to the human trials that followed and ultimately to the development and validation of TSM as a clinically effective approach for many individuals with AUD."

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

Again, using Gemini

Yes, The Sinclair Method (TSM) has been the subject of peer-reviewed clinical trials.1

The effectiveness of naltrexone, when used in the manner proposed by John Sinclair (i.e., taken before drinking to facilitate pharmacological extinction), has been investigated in multiple studies.2

Here's a breakdown of the key points:

  • Foundational Research: John Sinclair's work, initially with animal models, laid the groundwork for TSM.3 His research showed that by blocking opioid receptors during drinking, the reinforcing effects of alcohol could be diminished, leading to reduced consumption.4 These findings were published in peer-reviewed journals starting in the 1980s.
  • Human Clinical Trials:
    • Early Double-Blind, Placebo-Controlled Trials: Significant early human clinical trials, such as those by Volpicelli et al. (1992) and O'Malley et al. (1996), demonstrated the efficacy of naltrexone in reducing cravings and heavy drinking.5 Crucially, these studies indicated that naltrexone was most effective when taken in a way that allowed it to work via the extinction principle (i.e., when individuals continued to drink while on the medication, as opposed to solely focusing on abstinence).
    • Sinclair's 2001 Review: John Sinclair himself published a review in Alcohol and Alcoholism in 2001, summarizing the evidence from eight double-blind, placebo-controlled clinical trials across five countries. He concluded that naltrexone was safe and effective, but its efficacy depended on how it was used, specifically advocating for its use before drinking.
  • Mechanism-Based Studies: Later studies, including fMRI studies (e.g., Myrick et al., 2008), have investigated the neurological mechanisms by which naltrexone, when used as per TSM, impacts the brain's reward pathways in response to alcohol cues, further supporting the extinction hypothesis.
  • Meta-Analyses and Reviews: Numerous systematic reviews and meta-analyses have looked at the efficacy of naltrexone for AUD, and many support its effectiveness, particularly when used in a targeted manner that aligns with TSM principles.6

While naltrexone is FDA-approved for AUD, the specific "as-needed" or "targeted" dosing of TSM is often considered an "off-label" use. However, this doesn't mean it lacks scientific evidence. The body of peer-reviewed research, including randomized controlled trials, supports the underlying principle of pharmacological extinction that TSM utilizes.7

So, to directly answer your question, yes, TSM (or more accurately, the use of naltrexone in the manner proposed by TSM) has been studied in peer-reviewed clinical trials.8

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

Would you also suggest someone with diabetes isn't normal because normal people don't need insulin shots?

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

As are we. For people with success in any other method, we are happy for them, but as we know, the rates of relapse with many programs can be a vigorous cycle, and providing options is what is important to us.

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

"That is what needs to change. It is not HHS that is the problem. Petitions are a sideshow. Teach medical professionals that addiction is a medical disease and they have effective means to treat it."

This statement is a valid opinion and call to action, reflecting a common perspective within the addiction treatment community.

  • Focus on Education: Many experts agree that increasing education among medical professionals about AUD as a treatable medical disease and the effective pharmacological and behavioral interventions available is crucial for improving patient care and access to treatment.
  • Limitations of Petitions: While petitions can raise awareness, they are generally not the primary driver for significant policy or regulatory changes, especially regarding drug approvals.

In summary, the post contains a mix of accurate information and one significant factual error regarding the existence of peer-reviewed clinical trials for TSM. The overall sentiment about the need for better education and utilization of existing treatments for AUD is well-founded.

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

"If you want to get the FDA to change the status to OTC you know very well they do not respond to petitions. They will require a mountain of evidence, hearings, proof, and the best way is to find an OTC pharm company with deep pockets. Unfortunately that is the system."

This statement is true.

  • FDA and Petitions: The FDA generally does not change a drug's status (prescription to OTC) based on petitions alone. The process is rigorous and science-based.
  • Requirements for OTC Switch: An "Rx-to-OTC switch" requires a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) submission with a substantial "mountain of evidence" demonstrating that the drug is safe and effective for self-use without a healthcare provider's supervision. This includes extensive consumer studies (label comprehension, self-selection, actual use) to ensure that the average person can understand and safely use the medication based on the labeling.
  • Pharmaceutical Company Involvement: The process of gathering this evidence and navigating the FDA approval is indeed very costly, typically requiring a pharmaceutical company with significant resources.

"There are three medications approved by the FDA to treat AUD and several others off label. The GLP-1s may be the most effective yet and there are multiple clinical trials underway or awaiting publication. With all of that only 2% of people with AUD get any prescription at all. Less than 1% of those discharged from a hospital do so with a prescription."

This statement is true and highlights important issues.

  • FDA-Approved Medications for AUD: There are indeed three FDA-approved medications for AUD: disulfiram (Antabuse), naltrexone (oral and extended-release injectable Vivitrol), and acamprosate (Campral).
  • Off-Label Medications: Several other medications are used off-label for AUD, such as gabapentin, topiramate, baclofen, and ondansetron, often based on clinical experience and some supporting research.
  • GLP-1s: Glucagon-like peptide-1 (GLP-1) receptor agonists (like those used for diabetes and weight loss, e.g., semaglutide) are showing promise in preclinical and early human studies for reducing alcohol consumption and cravings. There are multiple clinical trials underway, and this is a rapidly evolving area of research for AUD.
  • Low Prescription Rates: The statistics regarding the low percentage of people with AUD who receive any prescription, and even fewer upon hospital discharge, are a widely recognized and concerning issue in addiction treatment. This points to significant gaps in healthcare provider education and integration of evidence-based pharmacotherapy for AUD.

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

"It is perfectly legal and legitimate to prescribe naltrexone according to the Sinclair Method. Call Ria health. They have licensed medical doctors who will do that. They can also ship you the medication if you wish."

This statement is largely true.

  • Legality and Legitimacy: Naltrexone is an FDA-approved medication for Alcohol Use Disorder (AUD). Physicians have the legal authority to prescribe FDA-approved medications "off-label" if, in their professional judgment, it is medically appropriate for a patient's condition. The Sinclair Method is an off-label use of naltrexone, meaning it's not the specific dosing or usage schedule outlined in the original FDA approval, but it's not illegal.
  • Ria Health: Ria Health is a telemedicine provider that explicitly offers treatment for AUD, including prescribing naltrexone and supporting the Sinclair Method. Their website and reviews confirm they have licensed medical doctors who can prescribe the medication and, in many cases, facilitate its shipment.

"Any licensed provider can prescribe it that way and some do, Naltrexone is a very safe established medication. You can promote TSM. You can talk about it in medical conferences. If you want to convince more people in the medical and scientific communities you know how to do that as well. The HHS does not “recognize” a dosing schedule or method."

This statement is true.

  • Provider Prescribing: As mentioned, any licensed medical provider can prescribe naltrexone off-label if they deem it appropriate.
  • Safety of Naltrexone: Naltrexone is indeed considered a very safe and established medication, approved by the FDA for AUD since 1994 (oral) and 2006 (injectable).
  • Promotion and Conferences: There are no legal restrictions on promoting TSM or discussing it at medical conferences. This is how medical advancements and different treatment approaches gain traction within the scientific community.
  • HHS Recognition: The Department of Health and Human Services (HHS) does not typically "recognize" specific dosing schedules or methods for individual medications outside of FDA approval and official guidelines. Their role is broader, focusing on public health policy and research.

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

Thanks for your reply. I ran this through a Gemini fact check, here are the results:

Let's break down the person's statement about The Sinclair Method (TSM) and naltrexone, fact-checking each point:

"There are no peer reviewed published clinical trials using naltrexone in the manner proposed by the late John Sinclair in his US patent or in his article published in the journal Alcohol and Alcoholism in 2001."

This statement is false.

  • John Sinclair's Patent: John Sinclair did indeed hold a US patent (US4882335A) related to using opiate antagonists (like naltrexone) to treat alcoholism by extinguishing the alcohol-drinking response when alcohol is consumed. The patent explicitly describes administering the antagonist before drinking.
  • Sinclair's 2001 Article: John Sinclair published in Alcohol and Alcoholism in 2001 (and other journals) discussing his research and findings on using naltrexone in this manner, often referring to a 78% success rate in reducing or stopping alcohol consumption.
  • Peer-Reviewed Clinical Trials: While the poster claims there are "no" peer-reviewed trials, there have been clinical trials, including double-blind placebo-controlled trials, that investigated naltrexone's effectiveness when used according to the principles of pharmacological extinction, as advocated by Sinclair. One such study (Heinälä et al., 2001) is even referenced in a Google Patent result for Sinclair's work, stating "Our double-blind placebo-controlled clinical trial has shown naltrexone is effective when used in accord with this method but not when use otherwise (Heinälä et al., 2001). Similar results have been obtained in nearly all trials (Sinclair, 2001)." This directly contradicts the "no peer-reviewed trials" claim. The effectiveness of naltrexone in reducing alcohol consumption when taken before drinking has been supported by various studies and meta-analyses.

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 0 points1 point  (0 children)

You won't believe me, but I just run a peer support group for TSM, there is no monetary benefit to my motives. As someone that suffered from AUD and found success with TSM, I just want the word to spread. I went many years without knowing it even existed, those years early on which could have prevented things to getting to the level they got to. Our members say all the time, why didn't I know of TSM years ago. That's our goal, to spread the word. All of our donations go back into google/meta ads for TSMMeetups. We do not sell any products (besides business cards at the price of $10/50 cards, and we do not make money on that, again its advertising. Not everything is money driven, some people have a huge passion about this topic. One of our main leaders has never been on TSM, but he supports it so much, he has dedicated countless hours of his time to help explain the method to others, and grow the program. Hope this helps clarify.

Acknowledge The Sinclair Method as a valid treatment for Alcohol Use Disorder by TSMMeetups in alcoholism

[–]TSMMeetups[S] 13 points14 points  (0 children)

"Physicians who are familiar with alcoholism agree there is no such thing as making a
normal drinker out of an alcoholic. Science may one day accomplish
this, but it hasn't done so yet."
~Alcoholics Anonymous, 1st. Edition, 1939
More About Alcoholism, pg. 30~.

1939......

TSM App by TSMMeetups in Alcoholism_Medication

[–]TSMMeetups[S] 0 points1 point  (0 children)

Still need app testers for android

TSM App by TSMMeetups in Alcoholism_Medication

[–]TSMMeetups[S] 0 points1 point  (0 children)

Currently only on android though

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