Naltrexone for Anxiety

(SSO Trial)

This trial explores how naltrexone, a medication typically used to block opioid effects, might affect anxiety by testing its role in fear extinction. Researchers aim to determine if the drug can influence how people unlearn fear when reminded of supportive people in their lives. Eligible participants should be healthy adults fluent in English, with no history of mental health issues or chronic physical illnesses. Participants will receive either naltrexone or a placebo, and researchers will assess the success of the fear extinction process. As an Early Phase 1 trial, this research focuses on understanding how naltrexone works in people, offering participants a chance to contribute to groundbreaking insights.

The trial requires that participants do not have a history of mental illness or take medications related to mental health disorders or liver function. If you are currently taking such medications, you would not be eligible to participate.

Research has shown that the FDA has approved naltrexone for treating opioid and alcohol dependence, confirming its safety in humans. In one study involving about 570 people using naltrexone for alcohol dependence, some reported new side effects such as anxiety (12%), joint pain (12%), and stomach pain (11%).

While these side effects are not rare, they are usually manageable. It's important to note that naltrexone can lead to more serious issues, such as the risk of opioid overdose if someone returns to using opioids. However, this risk applies only to those using opioids, not the healthy participants in this trial.

Unlike standard anxiety treatments that typically involve SSRIs or benzodiazepines, naltrexone offers a novel approach by targeting opioid receptors in the brain. This mechanism is different because it may help regulate mood and stress responses in a way that traditional anxiety medications do not. Researchers are excited about naltrexone because it could potentially offer relief for anxiety with fewer side effects than conventional medications, providing a new option for those who haven't found success with existing treatments.

Research has shown that naltrexone, a medication that blocks opioid effects, can help reduce anxiety and assist in treating addiction. For instance, one study found that people with alcohol addiction and anxiety improved significantly when taking naltrexone. Other studies on opioid addiction have also noted that a long-lasting form of naltrexone helped lower anxiety symptoms. Although most research has focused on addiction, these findings suggest that naltrexone might also help manage anxiety. In this trial, participants will receive either naltrexone or a placebo to evaluate its effectiveness in reducing anxiety. Naltrexone blocks certain brain receptors, which could affect how emotions and fear are processed.⁶⁷⁸⁹¹⁰