Subjective Stress Response TSST
| Group | Value (units on a scale) | Spread |
|---|---|---|
| TSST Women Oxytocin | 5.33 | 3.81 |
| TSST Women Placebo | 5.28 | 4.09 |
| TSST Men Oxytocin | 2.05 | 2.34 |
| TSST Men Placebo | 2.13 | 2.87 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.
Experimental
TSST Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Placebo comparator
TSST Women Placebo
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Experimental
MRI 1 Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
Placebo comparator
MRI 1 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
Experimental
MRI 2 Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
Placebo comparator
MRI 2 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
Experimental
TSST Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Placebo comparator
TSST Men Placebo
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Experimental
MRI I Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
Placebo comparator
MRI I Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
Experimental
MRI 2 Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
Placebo comparator
MRI 2 Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
Outcomes the sponsor listed as primary.
Subjective Stress Response TSST
Time frame · 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.
Subjective Stress Response MRI 1
Time frame · 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
Subjective Stress Response MRI 2
Time frame · 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.
Subject Cocaine Craving TSST
Time frame · 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.
Subject Cocaine Craving MRI 1
Time frame · 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.
Subject Cocaine Craving MRI 2
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (units on a scale) | Spread |
|---|---|---|
| TSST Women Oxytocin | 5.33 | 3.81 |
| TSST Women Placebo | 5.28 | 4.09 |
| TSST Men Oxytocin | 2.05 | 2.34 |
| TSST Men Placebo | 2.13 | 2.87 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| MRI 1 Women Oxytocin | 2.05 | 2.34 |
| MRI 1 Women Placebo | 2.13 | 2.87 |
| MRI 1 Men Oxytocin | 1.75 | 2.40 |
| MRI 1 Men Placebo | 2.66 | 2.84 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| MRI 2 Women Oxytocin | 0.83 | 1.67 |
| MRI 2 Women Placebo | 1.83 | 2.81 |
| MRI 2 Men Oxytocin | 1.07 | 2.07 |
| MRI 2 Men Placebo | 1.39 | 2.06 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| TSST Women Oxytocin | 3.08 | 3.69 |
| TSST Women Placebo | 3.24 | 3.38 |
| TSST Men Oxytocin | 3.45 | 3.35 |
| TSST Men Placebo | 3.45 | 3.35 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| MRI 1 Women Oxytocin | 2.89 | 3.31 |
| MRI 1 Women Placebo | 2.65 | 2.81 |
| MRI 1 Men Oxytocin | 3.04 | 2.70 |
| MRI 1 Men Placebo | 3.69 | 2.99 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| MRI 2 Women Oxytocin | 2.17 | 2.70 |
| MRI 2 Women Placebo | 2.61 | 2.78 |
| MRI 2 Men Oxytocin | 2.04 | 2.38 |
| MRI 2 Men Placebo | 2.29 | 2.54 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TSST Women OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs | 0 / 24 | 0 / 24 | 0 / 24 |
| TSST Women PlaceboCocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs | 0 / 25 | 0 / 25 | 0 / 25 |
| MRI 1 Women OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs | 0 / 19 | 0 / 19 | 0 / 19 |
| MRI 1 Women PlaceboCocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs | 0 / 23 | 0 / 23 | 0 / 23 |
| MRI 2 Women OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs | 0 / 23 | 0 / 23 | 0 / 23 |
| MRI 2 Women PlaceboCocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs | 0 / 18 | 0 / 18 | 0 / 18 |
| TSST Men OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs | 0 / 32 | 0 / 32 | 0 / 32 |
| TSST Men PlaceboCocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs | 0 / 31 | 0 / 31 | 0 / 31 |
| MRI I Men OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs | 0 / 28 | 0 / 28 | 0 / 28 |
| MRI I Men PlaceboCocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs | 0 / 29 | 0 / 29 | 0 / 29 |
| MRI 2 Men OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs | 0 / 27 | 0 / 27 | 0 / 27 |
| MRI 2 Men PlaceboCocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs | 0 / 28 | 0 / 28 | 0 / 28 |
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