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Oxytocin in Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Saline
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cocaine Dependence focused on measuring cocaine, substance abuse, drug abuse, cocaine dependence, drug addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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 Description

Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.

Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.

Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.

Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.

Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.

Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.

Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.

Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.

Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.

Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.

Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.

Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.

Outcomes

Primary Outcome Measures

Subjective Stress Response TSST
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 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 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

Subject Cocaine Craving TSST
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 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
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.

Full Information

First Posted
April 5, 2012
Last Updated
March 11, 2019
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01573273
Brief Title
Oxytocin in Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
December 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine, substance abuse, drug abuse, cocaine dependence, drug addiction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TSST Women Oxytocin
Arm Type
Experimental
Arm Description
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Arm Title
TSST Women Placebo
Arm Type
Placebo Comparator
Arm Description
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
Arm Title
MRI 1 Women Oxytocin
Arm Type
Experimental
Arm Description
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
Arm Title
MRI 1 Women Placebo
Arm Type
Placebo Comparator
Arm Description
Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
Arm Title
MRI 2 Women Oxytocin
Arm Type
Experimental
Arm Description
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
Arm Title
MRI 2 Women Placebo
Arm Type
Placebo Comparator
Arm Description
Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
Arm Title
TSST Men Oxytocin
Arm Type
Experimental
Arm Description
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
Arm Title
TSST Men Placebo
Arm Type
Placebo Comparator
Arm Description
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
Arm Title
MRI I Men Oxytocin
Arm Type
Experimental
Arm Description
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
Arm Title
MRI I Men Placebo
Arm Type
Placebo Comparator
Arm Description
Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
Arm Title
MRI 2 Men Oxytocin
Arm Type
Experimental
Arm Description
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
Arm Title
MRI 2 Men Placebo
Arm Type
Placebo Comparator
Arm Description
Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
pitocin
Intervention Description
intranasal administration, 40 IUs
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
pitocin
Intervention Description
intranasal administration, 40 IUs
Primary Outcome Measure Information:
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.
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.
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.
Secondary Outcome Measure Information:
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.
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 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. 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. Subjects must consent to random assignment. Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans. Exclusion Criteria Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control (not including hormonal contraceptives). Women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies. Women with premenstrual dysphoric disorder who are outside of the follicular phase. 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. 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. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements. Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response. 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. Subjects taking any mood stabilizers, antipsychotics, benzodiazepines, opiates or opiate antagonists because these may affect test response. Subjects taking SSRI's will be included. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation. Subjects whose height to weight ratio would preclude them from fitting comfortably in the MRI scanner. 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. Persons with ferrous metal implants or pacemaker since fMRI will be used. Subjects who are claustrophobic. Subjects with significant psychiatric or medical problems that would impair participation or limit ability to participate in scan. Subjects who require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee McRae-Clark, Pharm.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Oxytocin in Cocaine Dependence

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