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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 : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Megan Moran-Santa Maria, Medical University of South Carolina

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition: Cocaine Dependence
Interventions: Drug: oxytocin
Drug: saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Oxytocin oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Placebo saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.

Participant Flow:   Overall Study
    Oxytocin   Placebo
STARTED   17   16 
COMPLETED   17   16 
NOT COMPLETED   0   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
Oxytocin oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Placebo saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Total Total of all reporting groups

Baseline Measures
   Oxytocin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   16   33 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      17 100.0%      16 100.0%      33 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  35.3%      1   6.3%      7  21.2% 
Male      11  64.7%      15  93.8%      26  78.8% 
Region of Enrollment 
[Units: Participants]
     
United States   17   16   33 


  Outcome Measures

1.  Primary:   Salivary Cortisol Levels   [ Time Frame: 0 minutes post 15 minute stress task ]

2.  Secondary:   Likert Scale Rating of Subjective Stress   [ Time Frame: 0 minutes post 15 minute stress task ]

3.  Secondary:   Likert Scale Rating of Subjective Craving   [ Time Frame: 0 mintues post 15 minute stress task ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Moran-Santa Maria
Organization: MUSC
phone: 843-792-8187
e-mail: moranm@musc.edu



Responsible Party: Megan Moran-Santa Maria, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01963091     History of Changes
Other Study ID Numbers: Pro00009981
First Submitted: July 13, 2011
First Posted: October 16, 2013
Results First Submitted: December 18, 2013
Results First Posted: February 5, 2014
Last Update Posted: June 4, 2018