Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

• 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: Jennifer Mitchell
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Oxytocin	Placebo
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

Baseline Characteristics

Arm/Group Title		Oxytocin	Placebo	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Change in Craving to Use Alcohol Rating (Visual Analog Scale)
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

Outcome Measure Data

Analysis Population Description

All subjects who completed this outcome measure were included.

Arm/Group Title	Oxytocin	Placebo
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)
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

Outcome Measure Data

Analysis Population Description

All subjects who completed this outcome measure were included.

Arm/Group Title	Oxytocin	Placebo
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)

Adverse Events

Time Frame	From enrollment through study completion, an average of 1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Oxytocin	Placebo
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%)
Serious Adverse Events
	Oxytocin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/31 (0.00%)	0/32 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Jennifer Mitchell, PhD
• Organization: University of California, San Francisco
• Phone: 510-985-3921
• EMail: jennifer.mitchell@ucsf.edu

• 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