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NCT02058251 · ClinicalTrials.gov registry record · Phase 1
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
A Phase 1 study of Alcohol Use Disorders, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT02058251 is a Phase 1 study of Alcohol Use Disorders that has completed, run by Medical University of South Carolina. The registered enrollment target is 73 participants, below the 114-participant average among 8 other Alcohol Use Disorders trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02058251, a Phase 1 study of Alcohol Use Disorders, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxytocin
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02058251
The ClinicalTrials.gov registry entry for NCT02058251 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 114-participant average among 8 other Alcohol Use Disorders trials with a reported enrollment target (36% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Use Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02058251 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT02058251 about?
NCT02058251 is a clinical study titled "Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress". 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 woef...
What is the current status of trial NCT02058251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2014-02. Estimated completion is 2017-04.
What conditions does trial NCT02058251 study?
This clinical trial studies the following conditions: Alcohol Use Disorders.
What interventions are being tested in trial NCT02058251?
The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT02058251?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02058251 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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