Oxytocin in Cocaine Dependence

Not Applicable

Completed

Conditions: Cocaine Dependence

Interventions: Drug: Saline
Drug: Oxytocin

Registration Number: NCT01573273

Lead Sponsor: Medical University of South Carolina

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TSST Women Placebo	Saline	Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
MRI 1 Women Placebo	Saline	Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
MRI 2 Women Placebo	Saline	Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
TSST Men Placebo	Saline	Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
MRI I Men Placebo	Saline	Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
MRI 2 Men Placebo	Saline	Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
MRI 1 Women Oxytocin	Oxytocin	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
TSST Women Oxytocin	Oxytocin	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
MRI 2 Women Oxytocin	Oxytocin	Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
TSST Men Oxytocin	Oxytocin	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
MRI I Men Oxytocin	Oxytocin	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
MRI 2 Men Oxytocin	Oxytocin	Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.

Primary Outcome Measures

Name	Time	Method
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.
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
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

Name	Time	Method
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.
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.
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.