Trial Outcomes & Findings for Oxytocin Treatment of Alcohol Withdrawal (NCT NCT01212185)
NCT ID: NCT01212185
Last Updated: 2014-05-13
Results Overview
Total lorazepam (in milligrams) required per subject to complete detoxification
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Days 1 to 5
Results posted on
2014-05-13
Participant Flow
Participant milestones
| Measure |
Intranasal Spray Without Oxytocin
Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days
|
Intranasal Oxytocin Spray
Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Intranasal Spray Without Oxytocin
Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days
|
Intranasal Oxytocin Spray
Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Oxytocin Treatment of Alcohol Withdrawal
Baseline characteristics by cohort
| Measure |
Intranasal Spray Without Oxytocin
n=6 Participants
Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily
|
Intranasal Oxytocin Spray
n=8 Participants
Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.09 years
STANDARD_DEVIATION 8.32 • n=93 Participants
|
42.23 years
STANDARD_DEVIATION 10.87 • n=4 Participants
|
41.27 years
STANDARD_DEVIATION 14.67 • n=27 Participants
|
|
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
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 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
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 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
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (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
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
CIWA-Ar score
|
9.25 units on a scale
STANDARD_DEVIATION 6.6 • n=93 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 5.7 • n=27 Participants
|
|
Standard drinks/day over the past 2 weeks
|
14.5 standard drinks/day
STANDARD_DEVIATION 1.7 • n=93 Participants
|
17.7 standard drinks/day
STANDARD_DEVIATION 6.0 • n=4 Participants
|
16.4 standard drinks/day
STANDARD_DEVIATION 4.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: Days 1 to 5Total lorazepam (in milligrams) required per subject to complete detoxification
Outcome measures
| Measure |
Intranasal Spray Without Oxytocin
n=4 Participants
Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily
|
Intranasal Oxytocin Spray
n=7 Participants
Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
|
|---|---|---|
|
Total Lorazepam Dosage (in Milligrams)
|
16.5 milligrams of lorazepam
Standard Deviation 4.4
|
3.4 milligrams of lorazepam
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: days 1Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.
Outcome measures
| Measure |
Intranasal Spray Without Oxytocin
n=4 Participants
Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily
|
Intranasal Oxytocin Spray
n=7 Participants
Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
|
|---|---|---|
|
CIWA-Ar Scores
|
11.8 units on a scale
Standard Deviation 0.4
|
4.3 units on a scale
Standard Deviation 2.3
|
Adverse Events
Intranasal Spray Without Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intranasal Oxytocin Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intranasal Spray Without Oxytocin
n=6 participants at risk
Twice daily intranasal spray without oxytocin.
intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily
|
Intranasal Oxytocin Spray
n=8 participants at risk
Twice daily intranasal oxytocin spray
intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
|
|---|---|---|
|
Endocrine disorders
electrolyte abnormalities
|
0.00%
0/6
|
0.00%
0/8
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place