Posttraumatic stress disorder (
PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE)
therapy is one of the most widely used evidence-based treatments for
PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that
oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of
oxytocin (vs. placebo) administration combined with PE
therapy to (1) reduce
PTSD symptom severity, (2) accelerate the rate of
PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal
oxytocin (40 IU) will be administered directly prior to each PE
therapy session. Findings from this study will provide critical new information regarding the efficacy of
oxytocin to augment psychosocial treatment for
PTSD, as well as information regarding the physiological mechanisms underlying
PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.