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Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

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ClinicalTrials.gov Identifier: NCT02058251
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alcohol Use Disorders
Interventions Drug: Oxytocin
Drug: Placebo
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxytocin Control
Hide Arm/Group Description

Each participant will self-administer a 40 IU dose of intranasal oxytocin.

Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.

Each participant will self-administer a 40 IU dose of intranasal saline.

Placebo: Each participant will self-administer a 40 IU dose of intranasal saline.

Period Title: Overall Study
Started 35 38
Completed 35 38
Not Completed 0 0
Arm/Group Title Oxytocin Control Total
Hide Arm/Group Description

Each participant will self-administer a 40 IU dose of intranasal oxytocin.

Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.

Each participant will self-administer a 40 IU dose of intranasal saline.

Placebo: Each participant will self-administer a 40 IU dose of intranasal saline.

Total of all reporting groups
Overall Number of Baseline Participants 35 38 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 38 participants 73 participants
48.94  (9.75) 47.82  (11.27) 48.36  (10.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 38 participants 73 participants
Female
3
   8.6%
3
   7.9%
6
   8.2%
Male
32
  91.4%
35
  92.1%
67
  91.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 38 participants 73 participants
American Indian or Alaska Native
1
   2.9%
0
   0.0%
1
   1.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
  71.4%
19
  50.0%
44
  60.3%
White
8
  22.9%
18
  47.4%
26
  35.6%
More than one race
1
   2.9%
1
   2.6%
2
   2.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Alcohol Craving
Hide Description Using the Visual Analogue Scale (VAS), participants provided self-report ratings of subjective alcohol cravings on a scale of 1-10, with one being the lowest/better score, and 10 being the highest/worst outcome.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Main outcomes analyses were limited to male participants.
Arm/Group Title Oxytocin Control
Hide Arm/Group Description:

Each participant will self-administer a 40 IU dose of intranasal oxytocin.

Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.

Each participant will self-administer a 40 IU dose of intranasal saline.

Placebo: Each participant will self-administer a 40 IU dose of intranasal saline.

Overall Number of Participants Analyzed 32 35
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.89  (2.63) 3.08  (2.71)
2.Secondary Outcome
Title Stress Reactivity
Hide Description Salivary Cortisol (μg/dL). Greater cortisol levels are indicative of greater stress reactivity.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Main outcomes analyses were limited to male participants.
Arm/Group Title Oxytocin Control
Hide Arm/Group Description:

Each participant will self-administer a 40 IU dose of intranasal oxytocin.

Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.

Each participant will self-administer a 40 IU dose of intranasal saline.

Placebo: Each participant will self-administer a 40 IU dose of intranasal saline.

Overall Number of Participants Analyzed 32 35
Mean (Standard Deviation)
Unit of Measure: μg/dL
.14  (.10) .10  (.10)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Control
Hide Arm/Group Description

Each participant will self-administer a 40 IU dose of intranasal oxytocin.

Oxytocin: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.

Each participant will self-administer a 40 IU dose of intranasal saline.

Placebo: Each participant will self-administer a 40 IU dose of intranasal saline.

All-Cause Mortality
Oxytocin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/38 (0.00%) 
Hide Serious Adverse Events
Oxytocin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/38 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/38 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Sudie Back
Organization: Medical University of South Carolina
Phone: 843-792-5915
EMail: backs@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02058251    
Other Study ID Numbers: 018127-002 Seq. 1
First Submitted: February 6, 2014
First Posted: February 10, 2014
Results First Submitted: April 27, 2018
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019