Oxytocin in Cocaine Dependence

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01573273
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 12
• Duration (Months): 62.6
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Oxytocin; Drug: Saline	N/A

Detailed Description

Stress is an important predictor of relapse, and targeting stress-activated pathways may lead to therapeutic advancements in the treatment of substance use disorders. Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential effects have not been explored in cocaine-dependent individuals. Oxytocin receptors have been localized to brain regions that are activated by drug-paired cues and preclinical studies have shown that oxytocin attenuates the acute and long-term behavioral effects of psychostimulants. However, little is known about the role of oxytocin in mediating the affective response to cocaine-paired cues and associated neural activity in cocaine-dependent men and women. This project is a direct evolution from our previous SCOR-supported research. Our work has progressed from characterizing sex/gender differences in response to social stressors and cocaine cues in cocaine-dependent men and women, to our on-going work evaluating whether stress potentiates cue-induced craving and the impact of hormones on this response. The proposed study will investigate the role of oxytocin in the sex/gender differences in stress response and craving in cocaine-dependent individuals and preliminarily explore its therapeutic potential.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 19, 2017
• Actual Study Completion Date: Dec 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TSST Women Oxytocin Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.	Drug: Oxytocin; intranasal administration, 40 IUs; Other Names: pitocin
Placebo Comparator: TSST Women Placebo Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.	Drug: Saline; intranasal administration, 40 IUs; Other Names: pitocin
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.	Drug: Oxytocin; intranasal administration, 40 IUs; Other Names: pitocin
Placebo Comparator: MRI 1 Women Placebo Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.	Drug: Saline; intranasal administration, 40 IUs; Other Names: pitocin
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.	Drug: Oxytocin; intranasal administration, 40 IUs; Other Names: pitocin
Placebo Comparator: MRI 2 Women Placebo Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.	Drug: Saline; intranasal administration, 40 IUs; Other Names: pitocin
Experimental: TSST Men Oxytocin Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.	Drug: Oxytocin; intranasal administration, 40 IUs; Other Names: pitocin
Placebo Comparator: TSST Men Placebo Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.	Drug: Saline; intranasal administration, 40 IUs; Other Names: pitocin
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.	Drug: Oxytocin; intranasal administration, 40 IUs; Other Names: pitocin
Placebo Comparator: MRI I Men Placebo Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.	Drug: Saline; intranasal administration, 40 IUs; Other Names: pitocin
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.	Drug: Oxytocin; intranasal administration, 40 IUs; Other Names: pitocin
Placebo Comparator: MRI 2 Men Placebo Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.	Drug: Saline; intranasal administration, 40 IUs; Other Names: pitocin

Outcome Measures

Primary Outcome Measures

1. Subjective Stress Response TSST [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.

2. Subjective Stress Response MRI 1 [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

3. Subjective Stress Response MRI 2 [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.

Secondary Outcome Measures

1. Subject Cocaine Craving TSST [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.

2. Subject Cocaine Craving MRI 1 [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.

3. Subject Cocaine Craving MRI 2 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.

2. Subjects must meet DSM-IV criteria for current cocaine dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days. Alcohol has been known to affect HPA function (Adinoff et al., 1991), however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification. Also, due to the high comorbidity of cocaine and marijuana dependence, and limited evidence that marijuana use affects HPA function, subjects with marijuana dependence will be included.

3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the throughout study procedures.

4. Subjects must consent to random assignment.

5. Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans.

Exclusion Criteria

1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control (not including hormonal contraceptives).

2. Women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies.

3. Women with premenstrual dysphoric disorder who are outside of the follicular phase.

4. Women who have had a complete hysterectomy or are over 50 over one year post-menopausal, as ovarian hormones will be measured in the study.

5. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses. Neurological exclusions include history of stroke, seizure disorders, multiple sclerosis, Parkinson's disease, and Alzheimer's disease.

6. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status.

7. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.

8. Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response.

9. Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.

10. Subjects taking any mood stabilizers, antipsychotics, benzodiazepines, opiates or opiate antagonists because these may affect test response. Subjects taking SSRI's will be included.

11. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.

12. Subjects whose height to weight ratio would preclude them from fitting comfortably in the MRI scanner.

13. Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for three days prior to the stress task procedure.

14. Persons with ferrous metal implants or pacemaker since fMRI will be used.

15. Subjects who are claustrophobic.

16. Subjects with significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.

17. Subjects who require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.

18. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: Aimee McRae-Clark, Pharm.D., Medical University of South Carolina

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2016

More Information

Publications

None provided.

• Responsible Party: Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01573273
• Other Study ID Numbers: 00016890
• First Posted: Apr 9, 2012
• Last Update Posted: Mar 13, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina: cocaine; substance abuse; drug abuse; cocaine dependence; drug addiction
• Additional relevant MeSH terms: Cocaine-Related Disorders; Oxytocin

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	TSST Women Oxytocin	TSST Women Placebo	MRI 1 Women Oxytocin	MRI 1 Women Placebo	MRI 2 Women Oxytocin	MRI 2 Women Placebo	TSST Men Oxytocin	TSST Men Placebo	MRI I Men Oxytocin	MRI I Men Placebo	MRI 2 Men Oxytocin	MRI 2 Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs	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	Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs	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	Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs	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	Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs	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	Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs
Period Title: TSST : Trier Social Stress Task
STARTED	24	25	0	0	0	0	32	31	0	0	0	0
COMPLETED	24	25	0	0	0	0	32	31	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: TSST : Trier Social Stress Task
STARTED	0	0	19	23	0	0	0	0	28	29	0	0
COMPLETED	0	0	19	23	0	0	0	0	28	29	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: TSST : Trier Social Stress Task
STARTED	0	0	0	0	23	18	0	0	0	0	27	28
COMPLETED	0	0	0	0	23	18	0	0	0	0	27	28
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cocaine- Dependent Women Oxytocin	Cocaine- Dependent Men Oxytocin	Cocaine- Dependent Women Placebo	Cocaine -Dependent Men Placebo	Total
Arm/Group Description	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 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 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 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 of all reporting groups
Overall Participants	24	32	25	31	112
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	32 100%	25 100%	31 100%	112 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	24 100%	0 0%	25 100%	0 0%	49 43.8%
Male	0 0%	32 100%	0 0%	31 100%	63 56.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 4%	0 0%	1 0.9%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	18 75%	24 75%	13 52%	24 77.4%	79 70.5%
White	6 25%	8 25%	11 44%	7 22.6%	32 28.6%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%	32 100%	25 100%	31 100%	112 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Stress Response TSST
Description	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.
Time Frame	Subjects rated stress immediately following a Social Stress task on Day 1 of 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TSST Women Oxytocin	TSST Women Placebo	TSST Men Oxytocin	TSST Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs
Measure Participants	24	25	32	31
Mean (Standard Deviation) [units on a scale]	5.33 (3.81)	5.28 (4.09)	2.05 (2.34)	2.13 (2.87)

2. Primary Outcome

Title	Subjective Stress Response MRI 1
Description	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
Time Frame	Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI 1 Women Oxytocin	MRI 1 Women Placebo	MRI 1 Men Oxytocin	MRI 1 Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing the first of two MRI scans. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing the first of two MRI scans. Saline: intranasal administration, 40 IUs
Measure Participants	19	23	28	29
Mean (Standard Deviation) [units on a scale]	2.05 (2.34)	2.13 (2.87)	1.75 (2.40)	2.66 (2.84)

3. Primary Outcome

Title	Subjective Stress Response MRI 2
Description	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.
Time Frame	Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI 2 Women Oxytocin	MRI 2 Women Placebo	MRI 2 Men Oxytocin	MRI 2 Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing the second of two MRI scans. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing the second of two MRI scans. Saline: intranasal administration, 40 IUs
Measure Participants	23	18	27	28
Mean (Standard Deviation) [units on a scale]	0.83 (1.67)	1.83 (2.81)	1.07 (2.07)	1.39 (2.06)

4. Secondary Outcome

Title	Subject Cocaine Craving TSST
Description	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.
Time Frame	Subjects rated craving immediately following a Social Stress task on Day 1 of 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TSST Women Oxytocin	TSST Women Placebo	TSST Men Oxytocin	TSST Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs
Measure Participants	24	25	32	31
Mean (Standard Deviation) [units on a scale]	3.08 (3.69)	3.24 (3.38)	3.45 (3.35)	3.45 (3.35)

5. Secondary Outcome

Title	Subject Cocaine Craving MRI 1
Description	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.
Time Frame	Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI 1 Women Oxytocin	MRI 1 Women Placebo	MRI 1 Men Oxytocin	MRI 1 Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing the first of two MRI scans. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing the first of two MRI scans. Saline: intranasal administration, 40 IUs
Measure Participants	19	23	28	29
Mean (Standard Deviation) [units on a scale]	2.89 (3.31)	2.65 (2.81)	3.04 (2.70)	3.69 (2.99)

6. Secondary Outcome

Title	Subject Cocaine Craving MRI 2
Description	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.
Time Frame	Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MRI 2 Women Oxytocin	MRI 2 Women Placebo	MRI 2 Men Oxytocin	MRI 2 Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent women received intranasal saline prior to completing the second of two MRI scans. Saline: intranasal administration, 40 IUs	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two MRI scans. Oxytocin: intranasal administration, 40 IUs	Cocaine-dependent men received intranasal saline prior to completing the second of two MRI scans. Saline: intranasal administration, 40 IUs
Measure Participants	23	18	27	28
Mean (Standard Deviation) [units on a scale]	2.17 (2.70)	2.61 (2.78)	2.04 (2.38)	2.29 (2.54)

Adverse Events

Time Frame	Adverse events were collected from consent to the 1 month follow-up. That time period ranged from 6 weeks to 3 months.
Arm/Group Title	TSST Women Oxytocin		TSST Women Placebo		MRI 1 Women Oxytocin		MRI 1 Women Placebo		MRI 2 Women Oxytocin		MRI 2 Women Placebo		TSST Men Oxytocin		TSST Men Placebo		MRI I Men Oxytocin		MRI I Men Placebo		MRI 2 Men Oxytocin		MRI 2 Men Placebo
Arm/Group Description	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs		Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs		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		Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs		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		Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs		Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs		Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs		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		Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs		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		Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs
All Cause Mortality
	TSST Women Oxytocin		TSST Women Placebo		MRI 1 Women Oxytocin		MRI 1 Women Placebo		MRI 2 Women Oxytocin		MRI 2 Women Placebo		TSST Men Oxytocin		TSST Men Placebo		MRI I Men Oxytocin		MRI I Men Placebo		MRI 2 Men Oxytocin		MRI 2 Men Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)		0/19 (0%)		0/23 (0%)		0/23 (0%)		0/18 (0%)		0/32 (0%)		0/31 (0%)		0/28 (0%)		0/29 (0%)		0/27 (0%)		0/28 (0%)
Serious Adverse Events
	TSST Women Oxytocin		TSST Women Placebo		MRI 1 Women Oxytocin		MRI 1 Women Placebo		MRI 2 Women Oxytocin		MRI 2 Women Placebo		TSST Men Oxytocin		TSST Men Placebo		MRI I Men Oxytocin		MRI I Men Placebo		MRI 2 Men Oxytocin		MRI 2 Men Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)		0/19 (0%)		0/23 (0%)		0/23 (0%)		0/18 (0%)		0/32 (0%)		0/31 (0%)		0/28 (0%)		0/29 (0%)		0/27 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	TSST Women Oxytocin		TSST Women Placebo		MRI 1 Women Oxytocin		MRI 1 Women Placebo		MRI 2 Women Oxytocin		MRI 2 Women Placebo		TSST Men Oxytocin		TSST Men Placebo		MRI I Men Oxytocin		MRI I Men Placebo		MRI 2 Men Oxytocin		MRI 2 Men Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)		0/19 (0%)		0/23 (0%)		0/23 (0%)		0/18 (0%)		0/32 (0%)		0/31 (0%)		0/28 (0%)		0/29 (0%)		0/27 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.