Pregnenolone for Alcoholism

This trial tests whether pregnenolone, a natural hormone, can safely and effectively help individuals with Alcohol Use Disorder (AUD) reduce alcohol consumption. Participants will randomly receive either pregnenolone or a placebo (a pill with no active ingredients) daily for 12 weeks, followed by a check-up a month later. The trial seeks individuals who drink alcohol at least three times a week and meet the criteria for moderate to severe AUD. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

The trial requires you to stop using certain medications like opioids, anticonvulsants, sedatives, and some steroid medications. However, stable prescribed medications for conditions like high blood pressure, heart issues, diabetes, depression, and anxiety may be allowed after review by the study physician.

Research has shown that pregnenolone is generally safe for people. This treatment is a natural steroid produced by the body to help generate other hormones. It often appears in supplements, usually at lower doses than those tested in this trial.

Some studies have found that pregnenolone users might experience minor side effects, such as headaches, dizziness, or stomach issues. However, these side effects are uncommon and usually mild.

Researchers are excited about pregnenolone for treating alcoholism because it offers a fresh approach compared to standard treatments like naltrexone or acamprosate. Unlike these existing options, pregnenolone is a naturally occurring neurosteroid that may help regulate mood and stress, potentially reducing alcohol cravings. This unique mechanism of action targets the brain's stress response systems, providing a novel way to address the underlying issues of alcohol dependence. Additionally, being a natural compound, pregnenolone might offer a different side effect profile, making it an attractive option for individuals seeking alternatives to conventional medications.

This trial will compare pregnenolone with a placebo to evaluate its effectiveness for Alcohol Use Disorder (AUD). Studies have shown that pregnenolone can help reduce stress-related and alcohol-triggered cravings in people with AUD. It may also help balance the body's stress response, which is often disrupted in those with AUD. Some research suggests it might decrease heavy drinking episodes and improve overall well-being. However, other studies found no significant effect on alcohol consumption and preference. These mixed results indicate that while pregnenolone shows promise, more research is needed to fully understand its effectiveness for AUD.⁶⁷⁸⁹¹⁰