Trial record 2 of 2 for:
heinrichs oxytocin
Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
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ClinicalTrials.gov Identifier: NCT01963091 |
Recruitment Status
:
Completed
First Posted
: October 16, 2013
Results First Posted
: February 5, 2014
Last Update Posted
: February 5, 2014
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Sponsor:
Medical University of South Carolina
Information provided by (Responsible Party):
Megan Moran-Santa Maria, Medical University of South Carolina
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Tracking Information | ||||
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First Submitted Date ICMJE | July 13, 2011 | |||
First Posted Date ICMJE | October 16, 2013 | |||
Results First Submitted Date | December 18, 2013 | |||
Results First Posted Date | February 5, 2014 | |||
Last Update Posted Date | February 5, 2014 | |||
Study Start Date ICMJE | July 2011 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Salivary Cortisol Levels [ Time Frame: 0 minutes post 15 minute stress task ] salivary cortisol
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01963091 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals | |||
Official Title ICMJE | Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) |
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Condition ICMJE | Cocaine Dependence | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
33 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | October 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | 1) General Inclusion / Exclusion Criteria Inclusion Criteria
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01963091 | |||
Other Study ID Numbers ICMJE | Pro00009981 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Megan Moran-Santa Maria, Medical University of South Carolina | |||
Study Sponsor ICMJE | Medical University of South Carolina | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medical University of South Carolina | |||
Verification Date | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |