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Oxytocin in Cocaine Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01573273
First received: April 5, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention
Cocaine Dependence
Drug: Oxytocin
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Stress (as measured by cortisol and subjective report) [ Time Frame: During test procedure (3 days, approximately 18 hours total) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Craving (As measured by neuroimaging and subjective report) [ Time Frame: During test procedures (3 days, approximately 18 hours total) ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: October 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
intranasal administration
Drug: Oxytocin
intranasal administration, 40 IUs
Placebo Comparator: Saline
intranasal administration
Drug: Saline
intranasal administration, 40 IUs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 CTRC admission and throughout study procedures.
  4. Subjects must consent to random assignment.
  5. Subjects must be right-handed.
  6. Subjects must consent to outpatient admission to the CTRC 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 as this may impact on the response to the stress test procedure.
  4. Women who have had a complete hysterectomy or are 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 psychotropic medications, 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 who are obese (³ 20% over ideal weight) as this may interfere with hormonal status.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573273

Contacts
Contact: Lisa M Nunn, MS 843-792-0476 jenkinli@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lisa Nunn, MS    843-792-0476    jenkinli@musc.edu   
Principal Investigator: Aimee McRae-Clark, Pharm.D.         
Sub-Investigator: Kathleen Brady, M.D., Ph.D.         
Sub-Investigator: Megan Moran-Santa Maria, Ph.D.         
Sub-Investigator: Jane Joseph, Ph.D.         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Aimee McRae-Clark, Pharm.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01573273     History of Changes
Other Study ID Numbers: 00016890
Study First Received: April 5, 2012
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
cocaine
substance abuse
drug abuse
cocaine dependence
drug addiction

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014