Intranasal oxytocin's long-term effects on alcohol withdrawal and dependence investigated in follow-up RCT.

Alcohol withdrawal syndrome (AWS) is a serious and potentially life-threatening condition occurring after cessation of heavy alcohol use, often managed with benzodiazepines. While effective for acute withdrawal, benzodiazepines carry risks of dependence and sedation, and don't directly address long-term alcohol dependence or relapse prevention. There's a critical need for novel, non-addictive therapies that can both alleviate acute withdrawal symptoms and support sustained sobriety. Oxytocin, a neuropeptide involved in social bonding and stress regulation, has shown promise in preclinical and early clinical studies for modulating reward pathways and reducing craving, making it a candidate for alcohol use disorder treatment.

This Phase 3, randomized, placebo-controlled clinical trial (NCT03339024) enrolled 38 adults admitted for alcohol detoxification. Participants received either oxytocin nasal spray or placebo nasal spray during a 21-day benzodiazepine tapering period, followed by 4 weeks in an outpatient setting. The study aimed to evaluate oxytocin's ability to reduce withdrawal symptoms during tapering and assess its long-term effects on alcohol withdrawal and dependence at 60 days and 1 year, alongside safety profiling.