CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02058251
NCT02058251Phase 1Completed

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Medical University of South Carolina·interventional·Posted Feb 10, 2014·Updated Mar 14, 2019

In Brief

A Phase 1 clinical trial evaluating Oxytocin and Placebo for Alcohol Use Disorders. Completed, enrolled 73 participants across 1 site.

Detailed Summary

In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or systemic OT administration decreases activation of the amygdala in response to visual fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little attention has been focused on whether OT decreases SUD vulnerability after exposure to traumatic stress in preclinical or clinical studies. This clinical project will determine whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2014
Enrollment StartFeb 1, 2014
Primary CompletionJan 1, 2017
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.4 years ago

Interventions

Oxytocindrug

One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.

Placebodrug

Each participant will self-administer a 40 IU dose of intranasal saline.