Trial Outcomes & Findings for Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress (NCT NCT02058251)
NCT ID: NCT02058251
Last Updated: 2019-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
2 hours
Results posted on
2019-03-14
Participant Flow
Participant milestones
| Measure |
Oxytocin
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.
|
Control
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 Study
STARTED
|
35
|
38
|
|
Overall Study
COMPLETED
|
35
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Baseline characteristics by cohort
| Measure |
Oxytocin
n=35 Participants
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.
|
Control
n=38 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
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.94 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
47.82 years
STANDARD_DEVIATION 11.27 • n=7 Participants
|
48.36 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Main outcomes analyses were limited to male participants.
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.
Outcome measures
| Measure |
Oxytocin
n=32 Participants
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.
|
Control
n=35 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.
|
|---|---|---|
|
Alcohol Craving
|
2.89 scores on a scale
Standard Deviation 2.63
|
3.08 scores on a scale
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Main outcomes analyses were limited to male participants.
Salivary Cortisol (μg/dL). Greater cortisol levels are indicative of greater stress reactivity.
Outcome measures
| Measure |
Oxytocin
n=32 Participants
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.
|
Control
n=35 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.
|
|---|---|---|
|
Stress Reactivity
|
.14 μg/dL
Standard Deviation .10
|
.10 μg/dL
Standard Deviation .10
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place