Apremilast for Alcoholism

This trial tests a drug called apremilast to determine its effectiveness in helping people with Alcohol Use Disorders (AUD) reduce their drinking. Participants will be divided into groups to receive either 60mg or 90mg of apremilast, or a placebo (a pill with no active drug), to compare effectiveness. The goal is to gather data on apremilast's efficacy for those struggling with AUD. Individuals who have been drinking heavily (e.g., men consuming more than 14 drinks per week) and meet the criteria for AUD in the past 6 months may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

The trial does not clearly state if you need to stop all current medications, but it excludes those taking certain drugs that could affect the study, like disulfiram, naltrexone, and anticonvulsants. It's best to discuss your specific medications with the study doctor to see if they might interfere with the trial.

Studies have shown that apremilast, a drug already approved for other uses, is being tested to help with alcohol use disorders (AUD). In earlier research, participants taking apremilast experienced fewer issues with excessive alcohol consumption. Importantly, the drug was generally well-tolerated, with most participants not experiencing serious side effects.

Two different doses are being tested: 60mg per day and 90mg per day. Past research suggests that apremilast is safe for humans, as it is already used for other conditions, providing extensive safety information. However, like any medication, some individuals might experience mild side effects.

Researchers are excited about Apremilast for alcoholism because it offers a novel approach compared to traditional treatments like naltrexone or acamprosate, which primarily target neurotransmitter systems directly involved in addiction. Apremilast, originally used for inflammatory conditions like psoriasis, works by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which can modulate inflammation and immune responses, potentially affecting the underlying neurobiological pathways involved in addiction. This unique mechanism might help reduce alcohol cravings and relapse, providing a fresh angle in the fight against alcoholism. Additionally, the treatment is administered orally, making it convenient for daily use.

This trial will compare different dosages of apremilast for Alcohol Use Disorders (AUD). Research has shown that apremilast might help people with AUD reduce alcohol consumption. In previous studies, participants taking apremilast reduced their alcohol intake by more than half, from an average of five drinks per day. Additionally, those on apremilast drank less each day compared to those not taking the medication. Animal tests indicated that apremilast can lower alcohol consumption across different levels of AUD severity. These findings suggest that apremilast could be promising for managing excessive drinking in AUD.¹²⁵⁶⁷