Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: saline; Drug: oxytocin

• Registration Number: NCT01963091
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Results First Submitted: 2013-12-18
• Results First Submitted QC: 2013-12-18
• Results First Posted: 2014-02-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	saline	-
oxytocin	oxytocin	-

Primary Outcome Measures

Name	Time	Method
Salivary Cortisol Levels	0 minutes post 15 minute stress task	salivary cortisol

Secondary Outcome Measures

Name	Time	Method
Likert Scale Rating of Subjective Stress	0 minutes post 15 minute stress task	Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
Likert Scale Rating of Subjective Craving	0 mintues post 15 minute stress task	Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'

Trial Locations

Locations (1)

Clinical Neurosciences Division-MUSC; 🇺🇸 Charleston, South Carolina, United States