Trial Outcomes & Findings for Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress (NCT NCT02742532)

Last Updated: 2020-10-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Change from baseline to post-drug at 20 minutes

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Oxytocin Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril) Oxytocin: Intranasal oxytocin 40 IU	Placebo Intra-nasal saline placebo (5 puffs in each nostril) Placebo: Intranasal saline solution
Overall Study STARTED	31	32
Overall Study COMPLETED	28	31
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Some subjects declined to complete this data, so the row population differs from the overall.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=31 Participants Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril) Oxytocin: Intranasal oxytocin 40 IU	Placebo n=32 Participants Intra-nasal saline placebo (5 puffs in each nostril) Placebo: Intranasal saline solution	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=63 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=31 Participants	32 Participants n=32 Participants	63 Participants n=63 Participants
Age, Categorical >=65 years	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=63 Participants
Age, Continuous	27.09 years n=31 Participants	27.38 years n=32 Participants	27.24 years n=63 Participants
Sex: Female, Male Female	5 Participants n=31 Participants	3 Participants n=32 Participants	8 Participants n=63 Participants
Sex: Female, Male Male	26 Participants n=31 Participants	29 Participants n=32 Participants	55 Participants n=63 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=31 Participants	1 Participants n=32 Participants	2 Participants n=63 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants	1 Participants n=32 Participants	1 Participants n=63 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=31 Participants	1 Participants n=32 Participants	3 Participants n=63 Participants
Race (NIH/OMB) Black or African American	2 Participants n=31 Participants	0 Participants n=32 Participants	2 Participants n=63 Participants
Race (NIH/OMB) White	25 Participants n=31 Participants	29 Participants n=32 Participants	54 Participants n=63 Participants
Race (NIH/OMB) More than one race	1 Participants n=31 Participants	0 Participants n=32 Participants	1 Participants n=63 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=63 Participants
Region of Enrollment United States	31 participants n=31 Participants	32 participants n=32 Participants	63 participants n=63 Participants
Self-Reported Alcoholic drinks per week	51.2 standard drinks/week STANDARD_DEVIATION 39.9 • n=28 Participants • Some subjects declined to complete this data, so the row population differs from the overall.	43.9 standard drinks/week STANDARD_DEVIATION 45.9 • n=30 Participants • Some subjects declined to complete this data, so the row population differs from the overall.	47.4 standard drinks/week STANDARD_DEVIATION 42.9 • n=58 Participants • Some subjects declined to complete this data, so the row population differs from the overall.

PRIMARY outcome

Timeframe: Change from baseline to post-drug at 20 minutes

Population: All subjects who completed this outcome measure were included.

Outcome measures

Outcome measures
Measure	Oxytocin n=29 Participants Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril) Oxytocin: Intranasal oxytocin 40 IU	Placebo n=32 Participants Intra-nasal saline placebo (5 puffs in each nostril) Placebo: Intranasal saline solution
Change in Craving to Use Alcohol Rating (Visual Analog Scale)	0.076 score on a scale Standard Deviation 1.77	-0.928 score on a scale Standard Deviation 1.42

SECONDARY outcome

Timeframe: Change from baseline to post-drug at 20 minutes

Population: All subjects who completed this outcome measure were included.

Outcome measures

Outcome measures
Measure	Oxytocin n=29 Participants Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril) Oxytocin: Intranasal oxytocin 40 IU	Placebo n=32 Participants Intra-nasal saline placebo (5 puffs in each nostril) Placebo: Intranasal saline solution
Change in Stress Rating (Visual Analog Scale)	-0.755 score on a scale Standard Deviation 1.24	-1.268 score on a scale Standard Deviation 1.82

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Mitchell, PhD

University of California, San Francisco

Phone: 510-985-3921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place