Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Summary

The primary objective of the proposed Stage II study is to examine the efficacy of oxytocin (OT) as compared to placebo in reducing (1) alcohol use disorder (AUD) symptoms, and (2) post-traumatic stress disorder (PTSD) symptoms among Veterans receiving COPE therapy (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure). To evaluate purported neurobiological mechanisms of change, we will employ functional magnetic resonance imaging (fMRI) at pre- and post-treatment.

Timeline

Start

2021-03-29

Primary completion

2026-06-01

Completion

2026-12-01

Publications

• Back SE, Flanagan JC, Killeen T, Saraiya TC, Brown DG, Jarnecke AM, Rothbaum AO, Joseph J, Ana ES, de Arellano A, Shoemaker HL, Dixon RA, Nietert PJ, Brady KT. COPE and oxytocin for the treatment of co-occurring PTSD and alcohol use disorder: Design and methodology of a randomized controlled trial in U.S. military veterans. Contemp Clin Trials. 2023 Mar;126:107084. doi: 10.1016/j.cct.2023.107084. Epub 2023 Jan 13.

Drugs

Indications