From the Guidelines
The Sinclair method for naltrexone use as needed is not supported by the provided evidence for opioid use disorder, and its application in this context is not recommended. The evidence provided focuses on the use of naltrexone in opioid and alcohol use disorders, but it does not specifically address the Sinclair method for naltrexone use as needed in the context of opioid use disorder. According to 1, naltrexone is an antagonist of mu opioid receptors and can block the effects of opioid agonists, which can prevent the impulsive use of opioids in patients receiving naltrexone. However, the study does not provide information on the use of naltrexone as needed. Some key points to consider when using naltrexone include:
- Naltrexone has been shown to be helpful in maintaining abstinence from opioids in motivated populations 1
- Naltrexone has been associated with hepatic injury at supratherapeutic doses, and liver function tests are recommended at baseline and every three to six months 1
- Naltrexone cannot be used in patients in whom opioids are required for pain control, because it will block pain relief from opioid agonists and cause withdrawal symptoms 1 In contrast, 1 discusses the use of naltrexone in adolescents with opioid use disorders, but it does not provide information on the Sinclair method for naltrexone use as needed. Given the lack of evidence supporting the Sinclair method for naltrexone use as needed in the context of opioid use disorder, it is not recommended to use this method for opioid use disorder. Instead, healthcare providers should follow established treatment guidelines for opioid use disorder, which may include the use of naltrexone as part of a comprehensive treatment plan.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Evidence for the Sinclair Method
The Sinclair method involves the use of naltrexone as needed, rather than on a fixed schedule.
- The evidence for this method is based on the idea that naltrexone is most effective when used in conjunction with drinking, as it blocks the rewarding aspects of alcohol consumption and promotes extinction of the drinking behavior 2.
- Studies have shown that naltrexone is effective in reducing drinking and preventing relapse when used in this manner, with one study finding that naltrexone-treated subjects drank less, took longer to relapse, and had more time between relapses 3.
- Another study found that naltrexone was safe and effective when used as needed, with instructions to take the medication only when drinking was anticipated 2.
Comparison to Other Methods
- The Sinclair method differs from other methods of using naltrexone, such as taking it daily or in combination with supportive therapy.
- Studies have found that naltrexone is less effective when combined with supportive therapy that emphasizes abstinence, as opposed to therapy that accepts the possibility of relapse and teaches coping skills 2.
- The use of naltrexone as needed, as in the Sinclair method, may be more effective than daily use, as it allows the individual to take the medication only when needed, which can help to reduce side effects and improve adherence 2.
Efficacy and Safety
- The evidence suggests that the Sinclair method is safe and effective in reducing drinking and preventing relapse in individuals with alcohol dependence.
- Studies have found that naltrexone is well-tolerated and has a low risk of side effects, making it a viable treatment option for individuals with alcohol dependence 4.
- The use of naltrexone as needed, as in the Sinclair method, may be particularly beneficial for individuals who have difficulty adhering to a daily medication regimen or who experience side effects with daily use 2.