Pregnenolone for Alcoholism and Depression

(PREG-AUD-RO1 Trial)

This trial tests pregnenolone, a hormone, to determine if it can improve symptoms in people with both Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will receive either pregnenolone or a placebo for 12 weeks, and researchers will assess its effects on drinking, alcohol cravings, depression, and anxiety. The study will also use MRI to examine brain changes to understand pregnenolone's potential mechanisms. Adults diagnosed with both AUD and MDD may qualify for this trial if they are willing to undergo several tests and assessments. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Research has shown that pregnenolone is under investigation for its safety and effectiveness in individuals with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Earlier studies found that pregnenolone can help reduce alcohol cravings and stress in people with AUD, suggesting it might also improve mood and decrease drinking.

Regarding safety, studies are examining how safe and tolerable pregnenolone is for these conditions, but they do not provide specific details about side effects or negative reactions. Since this study is in a mid-stage phase, pregnenolone has been safe enough in earlier studies to continue, but more information is still being collected.

Unlike the standard treatments for alcoholism and depression, such as SSRIs, SNRIs, and behavioral therapy, pregnenolone is unique because it is a naturally occurring neurosteroid. Researchers are excited about pregnenolone because it may offer a new way to address these conditions by modulating the brain's stress response and mood regulation differently than traditional medications. This fresh approach could potentially lead to improved outcomes for individuals who haven't found success with existing therapies, offering new hope for those affected by these challenging conditions.

Research has shown that pregnenolone might help reduce cravings triggered by stress and alcohol in people with Alcohol Use Disorder (AUD). Studies suggest it can balance the body's stress response, potentially leading to fewer cravings and less anxiety. Pregnenolone might also alleviate depression symptoms, which often accompany AUD. Early findings indicate it could improve both alcohol-related and mood-related issues. In this trial, participants will receive either pregnenolone or a placebo to evaluate its potential impact on brain areas involved in addiction and mood control.²³⁵⁶⁷