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Oxytocin 2021-03-29 ClinicalTrials

Oxytocin to be Examined for Efficacy in Reducing AUD and PTSD Symptoms in Veterans Receiving COPE Therapy

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Background

Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD) frequently co-occur, particularly among Veterans, presenting a complex and debilitating challenge. This comorbidity often exacerbates symptoms, complicates treatment, and leads to poorer prognoses compared to either condition alone. Current integrated behavioral therapies, such as COPE (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure), are effective but may not achieve optimal outcomes for all patients. There is a critical need for adjunctive pharmacotherapies to enhance the efficacy of these established treatments. Oxytocin (OT), a neuropeptide with well-documented roles in social bonding, trust, and stress regulation, offers a promising avenue for modulating the neurobiological underpinnings of both AUD and PTSD.

Study Design

This proposed Stage II study will be a randomized, double-masked, placebo-controlled trial. Veterans with co-occurring AUD and PTSD will be enrolled while receiving COPE therapy. Participants will be randomized to receive either oxytocin (OT) or placebo as an adjunct. The primary endpoints are reductions in AUD and PTSD symptom severity. To investigate neurobiological mechanisms, functional magnetic resonance imaging (fMRI) will be conducted at pre- and post-treatment time points, aiming to elucidate how oxytocin impacts brain function related to these conditions.

Why It Matters

If successful, this study could establish oxytocin as a valuable pharmacological adjunct, significantly improving treatment outcomes for Veterans grappling with the complex comorbidity of AUD and PTSD. This population often experiences severe symptoms and high rates of relapse, highlighting the urgent need for enhanced therapeutic strategies. Integrating oxytocin could boost the efficacy of existing behavioral interventions like COPE, offering a more robust and comprehensive approach. Furthermore, the neurobiological insights gained from fMRI could deepen our understanding of how oxytocin modulates stress, fear, and reward pathways, potentially informing future drug development. This research could pave the way for a new, targeted adjunctive therapy for a highly challenging dual diagnosis.


oxytocin aud ptsd veterans co-occurring-disorders phase-2
Source: clinicaltrials:NCT04523922 · Ingested 2026-07-01 · Digest: gemini-2.5-flash