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Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

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ClinicalTrials.gov Identifier: NCT02742532
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
United States Department of Defense
Congressionally Directed Medical Research Programs
Eisenhower Army Medical Center
Information provided by (Responsible Party):
Jennifer Mitchell, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Conditions Alcohol Use Disorder
Stress Disorders, Post-Traumatic
Anxiety Disorders
Substance Use Disorders
Interventions Drug: Oxytocin
Drug: Placebo
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Oxytocin: Intranasal oxytocin 40 IU

Intra-nasal saline placebo (5 puffs in each nostril)

Placebo: Intranasal saline solution

Period Title: Overall Study
Started 31 32
Completed 28 31
Not Completed 3 1
Arm/Group Title Oxytocin Placebo Total
Hide Arm/Group Description

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Oxytocin: Intranasal oxytocin 40 IU

Intra-nasal saline placebo (5 puffs in each nostril)

Placebo: Intranasal saline solution

Total of all reporting groups
Overall Number of Baseline Participants 31 32 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
 100.0%
32
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 63 participants
27.09
(19 to 45)
27.38
(20 to 42)
27.24
(19 to 45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Female
5
  16.1%
3
   9.4%
8
  12.7%
Male
26
  83.9%
29
  90.6%
55
  87.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
American Indian or Alaska Native
1
   3.2%
1
   3.1%
2
   3.2%
Asian
0
   0.0%
1
   3.1%
1
   1.6%
Native Hawaiian or Other Pacific Islander
2
   6.5%
1
   3.1%
3
   4.8%
Black or African American
2
   6.5%
0
   0.0%
2
   3.2%
White
25
  80.6%
29
  90.6%
54
  85.7%
More than one race
1
   3.2%
0
   0.0%
1
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 32 participants 63 participants
31 32 63
Self-Reported Alcoholic drinks per week   [1] 
Mean (Standard Deviation)
Unit of measure:  Standard drinks/week
Number Analyzed 28 participants 30 participants 58 participants
51.2  (39.9) 43.9  (45.9) 47.4  (42.9)
[1]
Measure Analysis Population Description: Some subjects declined to complete this data, so the row population differs from the overall.
1.Primary Outcome
Title Change in Craving to Use Alcohol Rating (Visual Analog Scale)
Hide Description The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher cravings.
Time Frame Change from baseline to post-drug at 20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed this outcome measure were included.
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description:

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Oxytocin: Intranasal oxytocin 40 IU

Intra-nasal saline placebo (5 puffs in each nostril)

Placebo: Intranasal saline solution

Overall Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.076  (1.77) -0.928  (1.42)
2.Secondary Outcome
Title Change in Stress Rating (Visual Analog Scale)
Hide Description The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher stress.
Time Frame Change from baseline to post-drug at 20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed this outcome measure were included.
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description:

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Oxytocin: Intranasal oxytocin 40 IU

Intra-nasal saline placebo (5 puffs in each nostril)

Placebo: Intranasal saline solution

Overall Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.755  (1.24) -1.268  (1.82)
Time Frame From enrollment through study completion, an average of 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxytocin Placebo
Hide Arm/Group Description

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Oxytocin: Intranasal oxytocin 40 IU

Intra-nasal saline placebo (5 puffs in each nostril)

Placebo: Intranasal saline solution

All-Cause Mortality
Oxytocin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
Hide Serious Adverse Events
Oxytocin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxytocin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Mitchell, PhD
Organization: University of California, San Francisco
Phone: 510-985-3921
EMail: jennifer.mitchell@ucsf.edu
Layout table for additonal information
Responsible Party: Jennifer Mitchell, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02742532    
Other Study ID Numbers: NMCSD Oxytocin
First Submitted: April 14, 2016
First Posted: April 19, 2016
Results First Submitted: August 19, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020