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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
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 17 16
Completed 17 16
Not Completed 0 0
Arm/Group Title Oxytocin Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
6
  35.3%
1
   6.3%
7
  21.2%
Male
11
  64.7%
15
  93.8%
26
  78.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17 16 33
1.Primary Outcome
Title Salivary Cortisol Levels
Hide Description salivary cortisol
Time Frame 0 minutes post 15 minute stress task
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.18  (0.09) 0.22  (0.09)
2.Secondary Outcome
Title Likert Scale Rating of Subjective Stress
Hide Description Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'
Time Frame 0 minutes post 15 minute stress task
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.18  (3.49) 4.25  (2.93)
3.Secondary Outcome
Title Likert Scale Rating of Subjective Craving
Hide Description 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'
Time Frame 0 mintues post 15 minute stress task
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.35  (4.03) 3.13  (2.80)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Oxytocin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxytocin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
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
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