Trial Outcomes & Findings for Oxytocin in Cocaine Dependence (NCT NCT01573273)
NCT ID: NCT01573273
Last Updated: 2019-03-13
Results Overview
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Subjects rated stress immediately following a Social Stress task on Day 1 of 3.
Results posted on
2019-03-13
Participant Flow
112 is the total number of participants randomized. 112 completed the TSST, which was between groups. MRIs were within subjects; 99 completed at least MRI 1. 96 completed MRI's 1 and 2. Data is reported per testing condition.
Participant milestones
| Measure |
TSST Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
MRI 1 Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
Oxytocin: intranasal administration, 40 IUs
|
MRI 1 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
Saline: intranasal administration, 40 IUs
|
MRI 2 Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
Oxytocin: intranasal administration, 40 IUs
|
MRI 2 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
MRI I Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
Oxytocin: intranasal administration, 40 IUs
|
MRI I Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
Saline: intranasal administration, 40 IUs
|
MRI 2 Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
Oxytocin: intranasal administration, 40 IUs
|
MRI 2 Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
TSST : Trier Social Stress Task
STARTED
|
24
|
25
|
0
|
0
|
0
|
0
|
32
|
31
|
0
|
0
|
0
|
0
|
|
TSST : Trier Social Stress Task
COMPLETED
|
24
|
25
|
0
|
0
|
0
|
0
|
32
|
31
|
0
|
0
|
0
|
0
|
|
TSST : Trier Social Stress Task
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MRI 1
STARTED
|
0
|
0
|
19
|
23
|
0
|
0
|
0
|
0
|
28
|
29
|
0
|
0
|
|
MRI 1
COMPLETED
|
0
|
0
|
19
|
23
|
0
|
0
|
0
|
0
|
28
|
29
|
0
|
0
|
|
MRI 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MRI 2
STARTED
|
0
|
0
|
0
|
0
|
23
|
18
|
0
|
0
|
0
|
0
|
27
|
28
|
|
MRI 2
COMPLETED
|
0
|
0
|
0
|
0
|
23
|
18
|
0
|
0
|
0
|
0
|
27
|
28
|
|
MRI 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin in Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Cocaine- Dependent Women Oxytocin
n=24 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task on Day 1, and MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
|
Cocaine- Dependent Men Oxytocin
n=32 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task on Day 1, and MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
|
Cocaine- Dependent Women Placebo
n=25 Participants
Cocaine-dependent women received Placebo prior to completing a Social Stress Task on Day 1, and MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
|
Cocaine -Dependent Men Placebo
n=31 Participants
Cocaine-dependent men received Placebo prior to completing a Social Stress Task on Day 1, an MRI on Day 2 and an MRI on Day 3. The TSST task was between subjects; the MRI tasks were within subjects.
|
Total
n=112 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
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
112 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
49 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
63 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 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
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
79 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=93 Participants
|
32 participants
n=4 Participants
|
25 participants
n=27 Participants
|
31 participants
n=483 Participants
|
112 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Subjects rated stress immediately following a Social Stress task on Day 1 of 3.Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Outcome measures
| Measure |
TSST Women Oxytocin
n=24 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
n=25 Participants
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
n=32 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
n=31 Participants
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|
|
Subjective Stress Response TSST
|
5.33 units on a scale
Standard Deviation 3.81
|
5.28 units on a scale
Standard Deviation 4.09
|
2.05 units on a scale
Standard Deviation 2.34
|
2.13 units on a scale
Standard Deviation 2.87
|
PRIMARY outcome
Timeframe: Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels
Outcome measures
| Measure |
TSST Women Oxytocin
n=19 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
n=23 Participants
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
n=28 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
n=29 Participants
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|
|
Subjective Stress Response MRI 1
|
2.05 units on a scale
Standard Deviation 2.34
|
2.13 units on a scale
Standard Deviation 2.87
|
1.75 units on a scale
Standard Deviation 2.40
|
2.66 units on a scale
Standard Deviation 2.84
|
PRIMARY outcome
Timeframe: Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Outcome measures
| Measure |
TSST Women Oxytocin
n=23 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
n=18 Participants
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
n=27 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
n=28 Participants
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|
|
Subjective Stress Response MRI 2
|
0.83 units on a scale
Standard Deviation 1.67
|
1.83 units on a scale
Standard Deviation 2.81
|
1.07 units on a scale
Standard Deviation 2.07
|
1.39 units on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Subjects rated craving immediately following a Social Stress task on Day 1 of 3.Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.
Outcome measures
| Measure |
TSST Women Oxytocin
n=24 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
n=25 Participants
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
n=32 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
n=31 Participants
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|
|
Subject Cocaine Craving TSST
|
3.08 units on a scale
Standard Deviation 3.69
|
3.24 units on a scale
Standard Deviation 3.38
|
3.45 units on a scale
Standard Deviation 3.35
|
3.45 units on a scale
Standard Deviation 3.35
|
SECONDARY outcome
Timeframe: Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.
Outcome measures
| Measure |
TSST Women Oxytocin
n=19 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
n=23 Participants
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
n=28 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
n=29 Participants
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|
|
Subject Cocaine Craving MRI 1
|
2.89 units on a scale
Standard Deviation 3.31
|
2.65 units on a scale
Standard Deviation 2.81
|
3.04 units on a scale
Standard Deviation 2.70
|
3.69 units on a scale
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.
Outcome measures
| Measure |
TSST Women Oxytocin
n=23 Participants
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Women Placebo
n=18 Participants
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
TSST Men Oxytocin
n=27 Participants
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Oxytocin: intranasal administration, 40 IUs
|
TSST Men Placebo
n=28 Participants
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Saline: intranasal administration, 40 IUs
|
|---|---|---|---|---|
|
Subject Cocaine Craving MRI 2
|
2.17 units on a scale
Standard Deviation 2.70
|
2.61 units on a scale
Standard Deviation 2.78
|
2.04 units on a scale
Standard Deviation 2.38
|
2.29 units on a scale
Standard Deviation 2.54
|
Adverse Events
TSST Women Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TSST Women Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI 1 Women Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI 1 Women Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI 2 Women Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI 2 Women Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TSST Men Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TSST Men Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI I Men Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI I Men Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI 2 Men Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI 2 Men 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place