The Sinclair Method (TSM) for the Treatment of Alcoholism. Clinical Research Findings and Best Protocol for Success Updated 2014

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1 Information for Medical & Treatment Professionals The Sinclair Method (TSM) for the Treatment of Alcoholism Clinical Research Findings and Best Protocol for Success Updated 2014 "One medication, naltrexone, has been identified as a safe and effective treatment for alcohol dependence. - World Health Organization, 1996

2 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Updated 2014 Table of Contents Summary Selected Quotes from Significant Research About Research Findings JAMA Study Abstract Interpretation of Clinical Results Underlined, Italics & Bold Interpreting The Trial Data Trials Involving Naltrexone and/or Nalfamine Forum Naltrexone Clinical Update

3 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Ver: LB Summary In clinical trials, where Alcohol was combined with naltrexone or nalmefene, 90 out of 91 clinical trials found significant benefits. Craving, drinking levels, relapse levels and liver damage markers were found to decrease over time. (A list of all trials and their conclusions are included at the end of this booklet). Where Alcohol was NOT combined with naltrexone or nalmefene, 36 out of 37 trials found no significant benefits. Trials proved that naltrexone only worked when it is taken either just prior to drinking alcohol or during drinking. This is due to the mechanism of the drug, which relies on pharmacological extinction. Naltrexone, available in generic form in the United States and Canada, has been approved by the FDA since It is non-addictive and will cause few, if any adverse side-affects. Naltrexone can be prescribed by a family doctor, without additional requirement for counselling or psychological therapy. The Sinclair Method (TSM) protocol is as follows: The recommended dose for patients is 50mg to be taken one (1) hour before drinking. Patients may start naltrexone while intoxicated without adverse affect. No detoxification prior to treatment is required. Naltrexone is often prescribed incorrectly (without drinking). If used this way it will be no more effective than placebo. The Sinclair Method advises against using naltrexone during periods of abstinence. When patients are directed to take naltrexone according to the TSM protocol (one hour before drinking, and not on days when no drinking occurs) chances of success are greatest: 75% success rate in Finnish clinics; 85% in Florida clinics and 75% success rate in the NGO (CORD) trial in India have been documented. The NationaI Institute on Alcohol Abuse & Alcoholism (NIAAA) and the World Health Organization (WHO) estimate that current rehabilitation methods (including AA, CBT, long-term rehabilitation programs and other common non-pharmacological treatment methods) yield success rates of around 10-15%.

4 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Ver: LB Selected Quotes from Significant Research (Full Citation for All Research is Listed at the Back of this Document) "One medication, naltrexone, has been identified as a safe and effective treatment for alcohol dependence. (World Health Organization, 1996) "Of all drugs studied for the treatment of alcohol dependence, the evidence of efficacy is strongest for naltrexone... (New England Journal of Medicine, 1999) "Significant benefits of naltrexone are still present three years after start of treatment in patients always taking medication before drinking, on craving, drinking levels, and liver damage markers. (Alcoholism: Clinical and Experimental Research, 2000) "Naltrexone significantly better than placebo: lack of relapse to heavy drinking = 90% in naltrexone group vs. 61.4% (or 11.4% reported online) with placebo. (Journal of Addictive Diseases, 2000) "Naltrexone was safe and effective, especially with a high craving and a family history of alcoholism. (American Journal of Addiction, 2001) "Naltrexone may be of benefit to women who are unable to maintain total abstinence from alcohol...among those drinking, naltrexone significantly delayed the time to the second relapse and the time to the third relapse. (Alcoholism: Clinical and Experimental Research, 2008) Naltrexone reduced drinking days and heavy drinking days, plus craving in early onset drinkers and time between drinks in patients with more alcoholic relatives. (Alcoholism: Clinical and Experimental Research, 2008) "Naltrexone has been safe and effective, with a 75% success rate, when introduced in northern India with an extinction protocol including no prior detox and instruction to take naltrexone always before drinking but only when drinking is expected. (Proceedings of the Annual Meeting of the International Society on Addiction Medicine (ISAM), 2009)

5 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Updated 2014 About Research Findings

6 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Updated 2014 About Research Findings.Continued

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8 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Updated 2014 Interpretation of Clinical Trial Results: Trials Involving Naltrexone and/or Nalfamine SUMMARY OF RESEARCH FINDINGS: When extinction was possible, 90 out of 91 clinical trials found significant benefits from the opioid antagonist. When extinction was not possible, 36 out of 37 trials found no significant benefits from the opioid antagonist. (Source: Dr. R. Eskapa, PhD; Dr. D. Sinclair, PhD DEFINITION of EXTINCTION : Extinction, refers to Pharmacological Extinction. Pharmacological extinction works on the premise that Alcohol Dependence is a form of Pavlovian conditioning. When people drink alcohol, endorphins are released into the brain, and this reinforces the behavior of drinking alcohol. Naltrexone blocks these endorphins from binding to the brain's receptors and the alcohol drinking behavior is extinguished. When extinction is possible means: Where taking the opioid blocker, such as Naltrexone or Nalmefene, WITH alcohol was possible as part of the study. When extinction was not possible means: Taking the opioid blocker WITHOUT alcohol (example: Naltrexone AND Abstinence from Alcohol) was part of the study. KEY CONCLUSION: Where Alcohol was combined with Naltrexone or Nalmefene, 90 out of 91 clinical trials found significant benefits. Where Alcohol was NOT combined with Naltrexone or Nalmefene, 36 out of 37 trials found no significant benefits.

9 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Updated 2014 Key: Underlined, Italics & Bold How to Interpret The Trial Data on the Following Pages

10 The Sinclair Method (TSM) for Alcoholism: Using Naltrexone Correctly; Information for Medical & Treatment Professionals Updated 2014 Trials Involving Naltrexone and/or Nalfamine Trials Continued on Next Page NOTES:

11 Trials Involving Naltrexone and/or Nalfamine

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23 Source: Dr. R. Eskapa, PhD; Dr. D. Sinclair, PhD

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