Oxytocin to Enhance Integrated Treatment for AUD and PTSD

What Was Tested

The trial (phase 2) is built around Oxytocin.

To evaluate purported neurobiological mechanisms of change, the researchers will employ functional magnetic resonance imaging (fMRI) at pre- and post-treatment.

It had two arms (groups): Oxytocin Treatment Group (experimental) and Placebo Group (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Their group developed an integrated intervention entitled Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE).

COPE incorporates empirically validated cognitive-behavioral techniques for AUD with Prolonged Exposure (PE) therapy for PTSD.

Although the empirical and theoretical support for augmenting psychosocial interventions such as COPE with OT is robust, no studies to date have examined this combined approach.

To accomplish this, the researchers will employ a manualized, evidence-based, cognitive-behavioral intervention (COPE); a randomized, double-blind, placebo-controlled study design; and standardized, repeated dependent measures of clinical outcomes at multiple time points.

Who Took Part

175 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female; U.S. military Veteran, any race or ethnicity; aged 18-70 years. Able to provide written informed consent. Meet DSM-5 diagnostic criteria for current PTSD as assessed by the CAPS-5. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: participants on psychotropic medications which have been initiated during the past 4 weeks; pregnancy or breastfeeding for women; currently enrolled in behavioral treatment for aud or ptsd.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2021-03-29 with completion listed for 2026-04-13.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in PTSD symptom severity - clinician rated (time frame: From baseline to week 12 and 3 and 6 month follow ups). Change in PTSD symptom severity - self report (time frame: From baseline to week 12 and 3 and 6 month follow ups).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 175 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.