Trial Outcomes & Findings for Oxytocin Treatment of Alcohol Dependence (NCT NCT02251912)
NCT ID: NCT02251912
Last Updated: 2017-08-15
Results Overview
Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-08-15
Participant Flow
Participant milestones
| Measure |
Active
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Active
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Oxytocin Treatment of Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Active
n=12 Participants
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
n=10 Participants
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
10 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksMean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).
Outcome measures
| Measure |
Active
n=12 Participants
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
n=10 Participants
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
|---|---|---|
|
Proportion of Heavy Drinking Days
|
0.3072 proportion of days per week
Standard Error 0.094
|
0.5914 proportion of days per week
Standard Error 0.1024
|
PRIMARY outcome
Timeframe: 12 weeksThe mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.
Outcome measures
| Measure |
Active
n=12 Participants
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
n=10 Participants
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
|---|---|---|
|
Mean Weekly Drinks Per Drinking Day
|
4.8929 number of drinks per drinking day
Standard Error 0.5868
|
7.5621 number of drinks per drinking day
Standard Error 0.6108
|
SECONDARY outcome
Timeframe: 12 weeksMean weekly Penn Alcohol Craving Scale (PACS) scores.The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from: Minimum: 0 Maximum: 30 Lower scores are associated with better outcomes.
Outcome measures
| Measure |
Active
n=12 Participants
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
n=10 Participants
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
|---|---|---|
|
Alcohol Craving
|
10.8481 units on a scale
Standard Error 2.1254
|
12.6685 units on a scale
Standard Error 2.3122
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=12 participants at risk
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
|
Control
n=10 participants at risk
Intranasal placebo doses 2-3 times/day for 12 weeks
Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
nosebleed
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
Additional Information
Dr. Cort Pedersen
University of North Carolina at Chapel Hill
Phone: 919-923-3284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place