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ClinicalTrials.gov Identifier: NCT01011465
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : November 26, 2012
Last Update Posted : November 26, 2012
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Laura Kubzansky, Harvard School of Public Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Oxytocin
Placebo
Interventions: Drug: intranasal oxytocin
Drug: Placebo
Behavioral: Social support
Behavioral: No Social Support

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled in this study from 6/2008 to 4/2012. Initial screening was done by phone and email. Medical screening took place at a hospital clinic and the rest of the study took place at the Harvard School of Public Health.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After initial screening , participants were asked to sign consent form and screened in a medical clinic prior to group assignment. Participants were excluded for violating study criteria, including having BMI>30, high blood pressure, acute illness, smoking or drug use and chronic medical conditions. Refusal to sign consent also led to exclusion.

Reporting Groups
  Description
Female, OT, Alone

Effects of intranasal oxytocin and social support examined among women versus men.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, OT, Friend

Effects of intranasal oxytocin and social support examined among women versus men.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Female, Placebo, Alone

Effects of intranasal oxytocin and social support examined among women versus men.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, Placebo, Friend

Effects of intranasal oxytocin and social support examined among women versus men.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, OT, Alone

Effects of intranasal oxytocin and social support examined among men versus women.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, OT, Friend

Effects of intranasal oxytocin and social support examined among men versus women.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, Placebo, Alone

Effects of intranasal oxytocin and social support examined among men versus women.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, Placebo, Friend

Effects of intranasal oxytocin and social support examined among men versus women.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.

Participant Flow:   Overall Study
    Female, OT, Alone   Female, OT, Friend   Female, Placebo, Alone   Female, Placebo, Friend   Male, OT, Alone   Male, OT, Friend   Male, Placebo, Alone   Male, Placebo, Friend
STARTED   36   20   36   18   47   29   52   32 
COMPLETED   34   19   36   18   46   29   51   32 
NOT COMPLETED   2   1   0   0   1   0   1   0 
Withdrawal by Subject                2                1                0                0                1                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Female, OT, Alone

Effects of intranasal oxytocin and social support examined among women versus men.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, OT, Friend

Effects of intranasal oxytocin and social support examined among women versus men.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Female, Placebo, Alone

Effects of intranasal oxytocin and social support examined among women versus men.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Female, Placebo, Friend

Effects of intranasal oxytocin and social support examined among women versus men.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, OT, Alone

Effects of intranasal oxytocin and social support examined among men versus women.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, OT, Friend

Effects of intranasal oxytocin and social support examined among men versus women.

Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Male, Placebo, Alone

Effects of intranasal oxytocin and social support examined among men versus women.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
Male, Placebo, Friend

Effects of intranasal oxytocin and social support examined among men versus women.

Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.

Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
Total Total of all reporting groups

Baseline Measures
   Female, OT, Alone   Female, OT, Friend   Female, Placebo, Alone   Female, Placebo, Friend   Male, OT, Alone   Male, OT, Friend   Male, Placebo, Alone   Male, Placebo, Friend   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 36   20   36   18   47   29   52   32   270 
Age 
[Units: Participants]
 		                 
<=18 years   0   0   0   0   0   0   0   0   0 
Between 18 and 65 years   36   20   36   18   47   29   52   32   270 
>=65 years   0   0   0   0   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 32.9  (11.2)   28.7  (6.2)   34.3  (10.7)   33.7  (13.2)   34.8  (11.8)   28.4  (9.0)   36.0  (12.1)   32.4  (9.7)   33.2  (11.0) 
Gender 
[Units: Participants]
 		                 
Female   36   20   36   18   0   0   0   0   110 
Male   0   0   0   0   47   29   52   32   160 
Region of Enrollment 
[Units: Participants]
 		                 
United States   36   20   36   18   47   29   52   32   270 


  Outcome Measures

1.  Primary:   Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure   [ Time Frame: within 2 hours of treatment ]
  Show Outcome Measure 1

2.  Primary:   Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure).   [ Time Frame: 2 hours ]
  Show Outcome Measure 2

3.  Primary:   Speech Threat and Challenge   [ Time Frame: 2 hours ]
  Show Outcome Measure 3


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data collected earlier in the study is missing blood pressure data due to technical problems.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Laura Kubzansky
Organization: Harvard School of Public Health
phone: 617-432-3589
e-mail: lkubzans@hsph.harvard.edu


Publications of Results:

Other Publications:


Responsible Party: Laura Kubzansky, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01011465     History of Changes
Other Study ID Numbers: 1R21AG030632-01A2 ( U.S. NIH Grant/Contract )
First Submitted: November 10, 2009
First Posted: November 11, 2009
Results First Submitted: September 13, 2012
Results First Posted: November 26, 2012
Last Update Posted: November 26, 2012