Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

Tracking Information
First Submitted Date ICMJE	July 13, 2011
First Posted Date ICMJE	October 16, 2013
Results First Submitted Date	December 18, 2013
Results First Posted Date	February 5, 2014
Last Update Posted Date	February 5, 2014
Study Start Date ICMJE	July 2011
Actual Primary Completion Date	October 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 11, 2013)	Salivary Cortisol Levels [ Time Frame: 0 minutes post 15 minute stress task ]; salivary cortisol
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01963091 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 18, 2013)	Likert Scale Rating of Subjective Stress [ Time Frame: 0 minutes post 15 minute stress task ]Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'; Likert Scale Rating of Subjective Craving [ Time Frame: 0 mintues post 15 minute stress task ]Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
Original Secondary Outcome Measures ICMJE; (submitted: October 11, 2013)	Likert Scale Rating of Subjective Stress [ Time Frame: 0 minutes post 15 minute stress task ]Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'; Likert Scale Rating of Subjective Craving [ Time Frame: 0 mintues post 15 minute stress tasl ]Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
Official Title ICMJE	Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
Brief Summary	Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator)
Condition ICMJE	Cocaine Dependence
Intervention ICMJE	Drug: oxytocin Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary. Other Name: pitocin; Drug: saline Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Study Arms	Experimental: oxytocin Intervention: Drug: oxytocin; Placebo Comparator: placebo Intervention: Drug: saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 11, 2013)	33
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2012
Actual Primary Completion Date	October 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	1) General Inclusion / Exclusion 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 consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the CTRC admission. Nicotine dependence can affect HPA function therefore it would be ideal to exclude subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine dependence, this would seriously compromise the feasibility of recruitment. In addition, because of the high comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse and dependence will be included if they do not require medically supervised detoxification. Due to the high comorbidity of cocaine and marijuana dependence, individuals with marijuana dependence will be included.; Subjects must consent to random assignment.; Subjects must consent to outpatient admission to the CTRC. Exclusion Criteria; Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.; Women with premenstrual dysphoric disorder as this may impact on the response to the stress test procedure.; 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.; 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 psychotropic medications, opiates or opiate antagonists because these may affect test response. Subjects who have been maintained on SSRI's for 8 weeks will not be excluded.; Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.; Subjects who are > 30% over ideal weight or have a BMI greater than 35 will be considered for study participation based on the clinical judgment of study staff.; 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.; Subjects meeting DSM-IV criteria for substance dependence (other than alcohol, nicotine, marijuana orcocaine) within the past 60 days.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01963091
Other Study ID Numbers ICMJE	Pro00009981
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Megan Moran-Santa Maria, Medical University of South Carolina
Study Sponsor ICMJE	Medical University of South Carolina
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Megan Moran-Santa Maria, Ph.D. Medical University of South Carolina
PRS Account	Medical University of South Carolina
Verification Date	December 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP